JOB PURPOSE Sana Biotechnology is looking for a highly motivated scientist to join a dynamic, rapidly growing, and collaborative team in the Analytical Development Group. This individual will be at the forefront of gene therapy approaches utilizing a novel biological platform, and we are seeking a creative and hardworking individual that shares our excitement in the potential of this platform. He/she will drive the development of potency methods for our gene therapy programs and contribute to the analytical characterization of viral vectors for in-vitro research-based experiments. The candidate will execute assay development and testing activities as well as cell process efforts that lead to a robust and scalable manufacturing process. This position represents an excellent opportunity for career development, working closely with experienced cell and gene therapy scientists in a highly collaborative environment. DUTIES AND RESPONSIBILITIES Drive potency assay development for gene therapy programs, including flow cytometry, ELISA, Luminex or MSD, and gene expression assays. Develop MOA-reflective methodologies for use in both regulated (e.g. lot release, in-process, and stability testing) and unregulated environments (e.g. characterization, high throughput screening). Develop vector characterization assays, such as sizing and particle aggregation Develop, optimize, and execute robust and reproducible assays in support of both discovery research and pre-clinical development. Integrate data with cross-functional R&D teams and present data regularly at team meetings. Coordinate with various internal groups for evaluation of emerging vector products. Implement superb documentation of procedures and experiments to support tech transfer. Train and mentor junior associates. Contribute to Sana's mission and culture. QUALIFICATIONS Basic Qualifications Ph.D. in immunology, cell/molecular biology, virology or related field and up to 2+ yrs academic or industry experience. BA and/or MS plus 7+ yrs or equivalent combination of education and work experience. Strong knowledge of flow cytometry principles, method development & optimization and data analysis. Familiarity with development and /or qualification of cell-based and gene therapy therapeutics, including the development of analytical methods. Prior experience in development and execution of assays to characterize and measure proteins and DNA using a variety of methodologies including qPCR, ddPCR, electrophoresis, and ELISA. Excellent bench skills with attention to detail and high standards for data integrity and quality. Able to critically analyze data and troubleshoot methods and equipment. The candidate should be a team player, highly organized with excellent communication skills, demonstrate curiosity and scientific rigor and excellent problem-solving skills. Ability to engage in crucial conversations - providing and receiving feedback Demonstrated effective management of research associates. Preferred Qualifications Experience with cell-based viral titration assays (e.g. flow cytometry, PCR, ELISA). Experience with viral vector systems, production and/or purification. Experience with liquid handler automation platforms (e.g. Integra, Hamilton, Tecan) Familiarity with GxP principles and regulations as demonstrated by assay and/or technology transfer to GxP manufacturing, or significant laboratory support of IND/BLA submissions. Experience in authoring and reviewing documentation including technical documents, protocols and reports connected to assay development, validation and sample testing in IND filing documents. WORKING CONDITIONS Flexibility to work some evenings or weekends in support of cell culture processing Ability to travel PHYSICAL REQUIREMENTS Ability to perform assays, standard cell culture in a development lab.
04/21/2021
Full time
JOB PURPOSE Sana Biotechnology is looking for a highly motivated scientist to join a dynamic, rapidly growing, and collaborative team in the Analytical Development Group. This individual will be at the forefront of gene therapy approaches utilizing a novel biological platform, and we are seeking a creative and hardworking individual that shares our excitement in the potential of this platform. He/she will drive the development of potency methods for our gene therapy programs and contribute to the analytical characterization of viral vectors for in-vitro research-based experiments. The candidate will execute assay development and testing activities as well as cell process efforts that lead to a robust and scalable manufacturing process. This position represents an excellent opportunity for career development, working closely with experienced cell and gene therapy scientists in a highly collaborative environment. DUTIES AND RESPONSIBILITIES Drive potency assay development for gene therapy programs, including flow cytometry, ELISA, Luminex or MSD, and gene expression assays. Develop MOA-reflective methodologies for use in both regulated (e.g. lot release, in-process, and stability testing) and unregulated environments (e.g. characterization, high throughput screening). Develop vector characterization assays, such as sizing and particle aggregation Develop, optimize, and execute robust and reproducible assays in support of both discovery research and pre-clinical development. Integrate data with cross-functional R&D teams and present data regularly at team meetings. Coordinate with various internal groups for evaluation of emerging vector products. Implement superb documentation of procedures and experiments to support tech transfer. Train and mentor junior associates. Contribute to Sana's mission and culture. QUALIFICATIONS Basic Qualifications Ph.D. in immunology, cell/molecular biology, virology or related field and up to 2+ yrs academic or industry experience. BA and/or MS plus 7+ yrs or equivalent combination of education and work experience. Strong knowledge of flow cytometry principles, method development & optimization and data analysis. Familiarity with development and /or qualification of cell-based and gene therapy therapeutics, including the development of analytical methods. Prior experience in development and execution of assays to characterize and measure proteins and DNA using a variety of methodologies including qPCR, ddPCR, electrophoresis, and ELISA. Excellent bench skills with attention to detail and high standards for data integrity and quality. Able to critically analyze data and troubleshoot methods and equipment. The candidate should be a team player, highly organized with excellent communication skills, demonstrate curiosity and scientific rigor and excellent problem-solving skills. Ability to engage in crucial conversations - providing and receiving feedback Demonstrated effective management of research associates. Preferred Qualifications Experience with cell-based viral titration assays (e.g. flow cytometry, PCR, ELISA). Experience with viral vector systems, production and/or purification. Experience with liquid handler automation platforms (e.g. Integra, Hamilton, Tecan) Familiarity with GxP principles and regulations as demonstrated by assay and/or technology transfer to GxP manufacturing, or significant laboratory support of IND/BLA submissions. Experience in authoring and reviewing documentation including technical documents, protocols and reports connected to assay development, validation and sample testing in IND filing documents. WORKING CONDITIONS Flexibility to work some evenings or weekends in support of cell culture processing Ability to travel PHYSICAL REQUIREMENTS Ability to perform assays, standard cell culture in a development lab.
JOB TYPE: Direct SALARY RANGE: $43,000 - $63,000 Day shift - 4, 10 hour shifts per week with rotating on-call and weekend rotation Base pay range is $ depending upon education and experience JOB DESCRIPTION: Reports To: Laboratory Director General Summary: -Assists and performs various clinical laboratory procedures, including chemical, microscopic, bacteriologic tests to obtain data for the use in the diagnosis and treatment of diseases. Performs patient specimen analysis for diagnostic purposes, under the direct supervision of a Medical Technologist. Enters all results into the computer system. Responsible for cleaning, disinfecting and sterilizing various equipment and work areas in the laboratory. Maintains laboratory inventory. Participates in performance improvement activities. Essential Functions: o Conduct blood tests for transfusion purposes and perform blood counts. Dependability o Regular and Reliable Attendance. o Set up, maintain, calibrate, clean, and test sterility of medical laboratory equipment. Independence o Prepare standard volumetric solutions or reagents to be combined with samples, following standardized formulas or experimental procedures Analytical Thinking o Conduct chemical analyses of body fluids, such as blood or urine, using microscope or automatic analyzer to detect abnormalities or diseases and enter findings into computer. o Examine cells stained with dye to locate abnormalities. Initiative LAB TECHNICIAN/LAB TECHNOLOGIST - LOCATION: Cambridge, NE What sets us apart amont other rural healthcare providers is the integrated services with a wide range of of high quality care and advanced technology. Benefits include medical/dental insurance, vision insurance, life insurance, disability insurance, retirement plan, and critical illness insurance. REQUIREMENTS: Education and Experience: Successful completion of an accredited Medical Technology or Medical Laboratory Technician program or equivalent training, education and experience and a nationally recognized certification required. Two or three years laboratory equivalent experience preferred
04/21/2021
Full time
JOB TYPE: Direct SALARY RANGE: $43,000 - $63,000 Day shift - 4, 10 hour shifts per week with rotating on-call and weekend rotation Base pay range is $ depending upon education and experience JOB DESCRIPTION: Reports To: Laboratory Director General Summary: -Assists and performs various clinical laboratory procedures, including chemical, microscopic, bacteriologic tests to obtain data for the use in the diagnosis and treatment of diseases. Performs patient specimen analysis for diagnostic purposes, under the direct supervision of a Medical Technologist. Enters all results into the computer system. Responsible for cleaning, disinfecting and sterilizing various equipment and work areas in the laboratory. Maintains laboratory inventory. Participates in performance improvement activities. Essential Functions: o Conduct blood tests for transfusion purposes and perform blood counts. Dependability o Regular and Reliable Attendance. o Set up, maintain, calibrate, clean, and test sterility of medical laboratory equipment. Independence o Prepare standard volumetric solutions or reagents to be combined with samples, following standardized formulas or experimental procedures Analytical Thinking o Conduct chemical analyses of body fluids, such as blood or urine, using microscope or automatic analyzer to detect abnormalities or diseases and enter findings into computer. o Examine cells stained with dye to locate abnormalities. Initiative LAB TECHNICIAN/LAB TECHNOLOGIST - LOCATION: Cambridge, NE What sets us apart amont other rural healthcare providers is the integrated services with a wide range of of high quality care and advanced technology. Benefits include medical/dental insurance, vision insurance, life insurance, disability insurance, retirement plan, and critical illness insurance. REQUIREMENTS: Education and Experience: Successful completion of an accredited Medical Technology or Medical Laboratory Technician program or equivalent training, education and experience and a nationally recognized certification required. Two or three years laboratory equivalent experience preferred
We are looking for positive, outgoing, team-oriented staff with a strong work ethic and a desire to learn. Previous service experience is required. Our servers will: Take fantastic care of our guests Learn our menus and systems Be great team players and help as needed We offer flexible scheduling....
04/21/2021
Full time
We are looking for positive, outgoing, team-oriented staff with a strong work ethic and a desire to learn. Previous service experience is required. Our servers will: Take fantastic care of our guests Learn our menus and systems Be great team players and help as needed We offer flexible scheduling....
You don't need a culinary degree to work with Clover (though many of your colleagues will have them). Our employees have backgrounds ranging from fast food to fine dining, from kayaking instructor to photographer, recently-graduated college student to farmer to construction worker. We're looking for people who share our love...
04/21/2021
Full time
You don't need a culinary degree to work with Clover (though many of your colleagues will have them). Our employees have backgrounds ranging from fast food to fine dining, from kayaking instructor to photographer, recently-graduated college student to farmer to construction worker. We're looking for people who share our love...
At Dunkin' Donuts, we work hard and we have fun! We serve our guests the best, freshest coffee, made just the way they like it. Equally as important, we make sure our guests feel welcome, appreciated, and leave the store feeling just a little bit happier than when they walked...
04/21/2021
Full time
At Dunkin' Donuts, we work hard and we have fun! We serve our guests the best, freshest coffee, made just the way they like it. Equally as important, we make sure our guests feel welcome, appreciated, and leave the store feeling just a little bit happier than when they walked...
Overview: We are a Management Services company seeking a Legal Assistant to assist our Head of Advisory and Corporate Counsel. We offer a dynamic and rewarding work environment with growth opportunities and professional development support. This person will work on administrative, corporate, tax and banking matters for our clients. Main Responsibilities: ADMINISTRATIVE: Daily update and maintenance of internal records and compliance calendars for clients listing corporate, tax, banking and business registration tasks for such clients. CORPORATE: Maintain accurate and updated corporate records for US companies Register US companies with Secretary of State in states where they carry out business. File annual reports for US companies in state of incorporation/formation and states where they carry out business. Withdraw companies from states where they are registered. Dissolve companies. Identify any issues with above matters and find a timely solution by working with State administrative agencies by phone and email. Prepare minutes of US companies: to approve the annual accounts, to update officers and directors, to change the name of the company, capital increase, etc. Prepare basic corporate documentation (affidavit of domiciliation, non-disclosure agreement, etc.). TAX: Register US companies for corporate and sales tax in states where they have business/sales. Register US companies for withholding and unemployment insurance in states where they have employees. Close tax registrations when they are no longer needed by the US companies. Identify any issues with tax registrations and closures and find a timely solution by working with state administrative agencies by phone and email. Prepare and file IRS forms. BANKING: Open bank accounts for US companies. Bank account maintenance issues (update signatories on bank accounts, update change of address or change of name, etc.). Process credit/debit card requests. Close bank accounts. Work with our relationship manager at bank by email and phone to resolve issues in the above matters. Required Qualifications and Skills: Bachelor's degree in business or legal studies or Paralegal degree 1+ years of experience in an administrative, clerical position or Legal Assistant/Paralegal position (law firm is a plus) Proficiency in MS Office applications (Outlook, Word, Excel, PowerPoint) and Google applications (spreadsheets) Excellent organizational and time management skills Detail oriented with the ability to multitask and prioritize competing demands Ability to manage short term and long-term projects Ability to work independently and also collaboratively Outstanding interpersonal, verbal and written communication skills High level of confidentiality and discretion Besides their technical skills and experience, our most successful team members are customer-oriented, team players with positive attitudes. About Axelia Partners: US expansion comes with opportunities, but also challenges. Axelia Partners provides the support entrepreneurs need to expand and succeed in the US. Our cross-Atlantic business expertise enables foreign companies to set up their US operations efficiently and manage them compliantly. Our services include: Accounting ǀ Financial Control ǀ Tax Compliance ǀ Payroll Operations Setup ǀ HR Services ǀ Talent Search ǀ M&A With a personalized approach to delivering comprehensive business solutions and consulting services, Axelia Partners has become the trusted partner of hundreds of companies at every stage of their US venture. Learn more about Axelia Partners by visiting
04/21/2021
Full time
Overview: We are a Management Services company seeking a Legal Assistant to assist our Head of Advisory and Corporate Counsel. We offer a dynamic and rewarding work environment with growth opportunities and professional development support. This person will work on administrative, corporate, tax and banking matters for our clients. Main Responsibilities: ADMINISTRATIVE: Daily update and maintenance of internal records and compliance calendars for clients listing corporate, tax, banking and business registration tasks for such clients. CORPORATE: Maintain accurate and updated corporate records for US companies Register US companies with Secretary of State in states where they carry out business. File annual reports for US companies in state of incorporation/formation and states where they carry out business. Withdraw companies from states where they are registered. Dissolve companies. Identify any issues with above matters and find a timely solution by working with State administrative agencies by phone and email. Prepare minutes of US companies: to approve the annual accounts, to update officers and directors, to change the name of the company, capital increase, etc. Prepare basic corporate documentation (affidavit of domiciliation, non-disclosure agreement, etc.). TAX: Register US companies for corporate and sales tax in states where they have business/sales. Register US companies for withholding and unemployment insurance in states where they have employees. Close tax registrations when they are no longer needed by the US companies. Identify any issues with tax registrations and closures and find a timely solution by working with state administrative agencies by phone and email. Prepare and file IRS forms. BANKING: Open bank accounts for US companies. Bank account maintenance issues (update signatories on bank accounts, update change of address or change of name, etc.). Process credit/debit card requests. Close bank accounts. Work with our relationship manager at bank by email and phone to resolve issues in the above matters. Required Qualifications and Skills: Bachelor's degree in business or legal studies or Paralegal degree 1+ years of experience in an administrative, clerical position or Legal Assistant/Paralegal position (law firm is a plus) Proficiency in MS Office applications (Outlook, Word, Excel, PowerPoint) and Google applications (spreadsheets) Excellent organizational and time management skills Detail oriented with the ability to multitask and prioritize competing demands Ability to manage short term and long-term projects Ability to work independently and also collaboratively Outstanding interpersonal, verbal and written communication skills High level of confidentiality and discretion Besides their technical skills and experience, our most successful team members are customer-oriented, team players with positive attitudes. About Axelia Partners: US expansion comes with opportunities, but also challenges. Axelia Partners provides the support entrepreneurs need to expand and succeed in the US. Our cross-Atlantic business expertise enables foreign companies to set up their US operations efficiently and manage them compliantly. Our services include: Accounting ǀ Financial Control ǀ Tax Compliance ǀ Payroll Operations Setup ǀ HR Services ǀ Talent Search ǀ M&A With a personalized approach to delivering comprehensive business solutions and consulting services, Axelia Partners has become the trusted partner of hundreds of companies at every stage of their US venture. Learn more about Axelia Partners by visiting
TEAM: GENERAL & ADMINISTRATIVE What You'll Do The Legal Administrator will assist the legal department with managing contract workflow, including processing of contracts from initial request to document execution, and entry into our contract management system. You will review certain standard agreement types, such as Confidential Disclosure Agreements, Statements of Work, Consulting Agreements, as well as manage other contract templates with guidance from attorneys. You will interact with internal departments as well as external vendors with respect to various contract inquiries. You will coordinate with our finance department on various corporate governance matters, including state filings, stock ledger management, and other related matters. The Legal Administrator will also assist with legal budget management, including external counsel, vendor invoicing and other legal department special projects as needed. The Impact You Will Have This is not your average legal administration role. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first. Your Superpowers You have a BSc or BA; paralegal or similar legal certification. You have experience working in a pharmaceutical company or big law firm. You are highly proficient in MS Office. You can handle a very fast-paced, high-volume workflow and can quickly assimilate internal systems. You are a great communicator. If you can speak Mandarin that is a plus. You can communicate with various levels of the organization, including senior management You can participate and work effectively on multiple cross-functional teams You understand relationships are key and have strong interpersonal skills. You can thrive in a smaller company environment and love the pace of a true startup. You're a team player who is willing to roll-up your sleeves and get the job done.
04/21/2021
Full time
TEAM: GENERAL & ADMINISTRATIVE What You'll Do The Legal Administrator will assist the legal department with managing contract workflow, including processing of contracts from initial request to document execution, and entry into our contract management system. You will review certain standard agreement types, such as Confidential Disclosure Agreements, Statements of Work, Consulting Agreements, as well as manage other contract templates with guidance from attorneys. You will interact with internal departments as well as external vendors with respect to various contract inquiries. You will coordinate with our finance department on various corporate governance matters, including state filings, stock ledger management, and other related matters. The Legal Administrator will also assist with legal budget management, including external counsel, vendor invoicing and other legal department special projects as needed. The Impact You Will Have This is not your average legal administration role. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first. Your Superpowers You have a BSc or BA; paralegal or similar legal certification. You have experience working in a pharmaceutical company or big law firm. You are highly proficient in MS Office. You can handle a very fast-paced, high-volume workflow and can quickly assimilate internal systems. You are a great communicator. If you can speak Mandarin that is a plus. You can communicate with various levels of the organization, including senior management You can participate and work effectively on multiple cross-functional teams You understand relationships are key and have strong interpersonal skills. You can thrive in a smaller company environment and love the pace of a true startup. You're a team player who is willing to roll-up your sleeves and get the job done.
Principal Scientist, Medicinal Chemistry US-MA-Cambridge Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Research & Development Nuvalent Overview With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Nuvalent is funded by Deerfield Management. Job Summary: We seek an entrepreneurial Medicinal Chemist with strong technical and problem-solving skills in organic and medicinal chemistry. The scientist in this position will work with the Nuvalent team, including the scientific founder, and will be responsible for leading medicinal chemistry efforts on at least one early-stage project operating under a virtual/CRO model. As a member of a small team, the Principal Scientist is expected to execute across all aspects of medicinal chemistry. Key initial responsibilities will include data analysis, SAR hypothesis generation, empirical and structure-based target design, and synthetic design and troubleshooting. Further, the scientist will be responsible for external CRO team management and interfacing with Nuvalent's internal biology, computational chemistry, and DMPK teams. The ideal candidate is well-versed and experienced in organic synthesis and medicinal chemistry; has experience managing chemistry outsourcing; and has exceptional written and oral communication skills, interpersonal skills, and critical thinking skills. The candidate will have experience applying structure-based drug design to hits and leads in the kinase space, including optimization of potency, selectivity and ADMET properties (including CNS exposure). Experience participating in and possibly leading programs from hit identification to candidate nomination is highly desirable. Responsibilities Opportunity and Responsibilities: Drive medicinal chemistry efforts and structure-based drug discovery on kinase projects: designing high quality small molecules to enable and progress projects, from hit identification to candidate selection. Drive exploratory chemistry efforts to enable new target selection. Manage outsourced chemistry resources: establishing and maintaining working relationships with external providers. Creatively solve project issues (synthetic routes, logistics etc.) to ensure on-track delivery of project objectives. Opportunity to lead drug discovery projects. Qualifications Minimum Requirements Ph.D. in organic chemistry with 7+ years of hands-on Medicinal Chemistry experience in the (bio)pharmaceutical industry Deep knowledge and demonstrated problem-solving skills in organic and medicinal chemistry Significant experience applying structural information and molecular modeling to drug design in the kinase inhibitor space Understanding of the drug discovery process and a proven track record of contributing to the iden-tification of lead compounds and clinical candidates Excellent communication and presentation skills: capable of conveying scientific information in a clear and thorough manner Experience in managing outsourced chemistry teams (CRO teams) Ability to think critically with strong attention to detail Ability to work independently and determine appropriate resources to overcome challenges Sound knowledge of related disciplines (DMPK, biology, tox, etc.) Cheminformatics experience is a plus Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI PI
04/20/2021
Full time
Principal Scientist, Medicinal Chemistry US-MA-Cambridge Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Research & Development Nuvalent Overview With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Nuvalent is funded by Deerfield Management. Job Summary: We seek an entrepreneurial Medicinal Chemist with strong technical and problem-solving skills in organic and medicinal chemistry. The scientist in this position will work with the Nuvalent team, including the scientific founder, and will be responsible for leading medicinal chemistry efforts on at least one early-stage project operating under a virtual/CRO model. As a member of a small team, the Principal Scientist is expected to execute across all aspects of medicinal chemistry. Key initial responsibilities will include data analysis, SAR hypothesis generation, empirical and structure-based target design, and synthetic design and troubleshooting. Further, the scientist will be responsible for external CRO team management and interfacing with Nuvalent's internal biology, computational chemistry, and DMPK teams. The ideal candidate is well-versed and experienced in organic synthesis and medicinal chemistry; has experience managing chemistry outsourcing; and has exceptional written and oral communication skills, interpersonal skills, and critical thinking skills. The candidate will have experience applying structure-based drug design to hits and leads in the kinase space, including optimization of potency, selectivity and ADMET properties (including CNS exposure). Experience participating in and possibly leading programs from hit identification to candidate nomination is highly desirable. Responsibilities Opportunity and Responsibilities: Drive medicinal chemistry efforts and structure-based drug discovery on kinase projects: designing high quality small molecules to enable and progress projects, from hit identification to candidate selection. Drive exploratory chemistry efforts to enable new target selection. Manage outsourced chemistry resources: establishing and maintaining working relationships with external providers. Creatively solve project issues (synthetic routes, logistics etc.) to ensure on-track delivery of project objectives. Opportunity to lead drug discovery projects. Qualifications Minimum Requirements Ph.D. in organic chemistry with 7+ years of hands-on Medicinal Chemistry experience in the (bio)pharmaceutical industry Deep knowledge and demonstrated problem-solving skills in organic and medicinal chemistry Significant experience applying structural information and molecular modeling to drug design in the kinase inhibitor space Understanding of the drug discovery process and a proven track record of contributing to the iden-tification of lead compounds and clinical candidates Excellent communication and presentation skills: capable of conveying scientific information in a clear and thorough manner Experience in managing outsourced chemistry teams (CRO teams) Ability to think critically with strong attention to detail Ability to work independently and determine appropriate resources to overcome challenges Sound knowledge of related disciplines (DMPK, biology, tox, etc.) Cheminformatics experience is a plus Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI PI
Human Resources Business Partner Cambridge, OH 43725, USA Req #10444 Friday, March 26, 2021 Cornerstone Building Brands is the largest manufacturer of exterior building products in North America. Our comprehensive portfolio spans the breadth of the residential and commercial markets, while our expansive footprint enables us to serve customers and communities across North America. Our relentless focus on excellence combined with our ongoing commitment to innovation and R&D has driven us to become the #1 manufacturer of windows, vinyl siding, insulated metal panels, metal roofing and wall systems, and metal accessories. We believe every building we create, and every part of that building, positively contributes to communities where people live, work and play. Summary We are currently seeking a Human Resources Business Partner (HRBP) in our Cambridge Ohio location. HRBP's responsibilities include full-scale HR Generalist support associated with a manufacturing facility. The HRBP will be involved in the development and implementation of strategic HR programs in partnership with the plant leadership and HR teams. The role provides expertise in the areas of employee relations, workforce planning, talent acquisition, performance management, employee retention, coaching/development, conflict management and ad hoc projects, as necessary. This is an exempt day shift position; however, candidates must be flexible to provide HR assistance to multiple shift personnel. Education and Experience * Bachelor level in Human Resources, Business, or Related Degree; or equivalent work experience required. * 1+ years of progressive experience within the HR function as a business partner * Experience objectively coaching employees and management through complex, difficult and emotional issues * Experience within a unionized environment required * Demonstrated ability to interact with all levels of employees in the organization including senior leaders * Must be proficient with MS Office (MS Word, Excel, PowerPoint, and Outlook). * Excellent organizational, analytical, problem solving, interpersonal, and communication skills * Ability to collaborate in a matrix organization, prioritize and provide excellent customer service in a fast-paced environment. * An advanced related degree is a plus. Essential Functions and Responsibility * Proactively provides strategic HR partnership to assigned client groups in a manufacturing environment to achieve company goals * Work with business leaders to build cohesive working relations and ensure the effective implementation and execution of HR initiatives * Proactively identify opportunities and assess improvements to the employee experience and partner with leadership to develop and implement innovative and lasting solutions. * Serve as internal consultant and change agent by analyzing current HR programs and recommending solutions * Coach leaders on complex employee relations matters and collaborate with HR operations to ensure compliance * execute performance management programs and procedures, including but not limited to performance appraisals and performance improvement plans * Partner with the Talent Acquisition team to identify staffing requirements needed to meet the goals and objectives of the organization * Understands and solicits employee feedback and anticipates their needs and concerns * Partner with HR COEs/Shared Services to deliver leadership and employee development, talent acquisition and management, total rewards, and operational activities. * Foster a high performing and highly engaged culture Benefits Offered * Benefits start day one! * Share in the Rewards for our Performance: Quarterly Gainsharing Bonus based on the performance of our plant * Recharge: 11 Company paid Holidays, Paid Sick and vacation time * Save for the future: 401k with Company Match * Continue to learn and grow: Tuition Reimbursement, Company Training to improve your skills * Be well: Medical, Dental, Vision, Wellness programs, Employee Assistance Program, Flexible Spending Account. * Short and Long-Term disability * Paid life insurance * Refer a friend sign on bonus Cornerstone Building Brands is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of age, race, religion, color, protected veteran status, disability, sex, gender identity, sexual orientation or national origin. Recruitment Fraud We have been made aware of multiple scams whereby unauthorized individuals are using Cornerstone Building Brand's name and logo to solicit potential job-seekers for employment. In some cases, job-seekers are being contacted directly, both by phone and e-mail. In other instances, these unauthorized individuals are placing advertisements for fake positions with both legitimate websites and fabricated ones. These individuals are typically promising high-paying jobs with the requirement that the job-seeker send money to pay for things such as visa applications or processing fees. Please be advised that Cornerstone Building Brands will never ask potential job-seekers for any sort of advance payment or bank account information as part of the recruiting or hiring process. Other details * Job Family Human Resources * Pay Type Salary * Travel Required No * Required Education Equivalent Experience
04/20/2021
Full time
Human Resources Business Partner Cambridge, OH 43725, USA Req #10444 Friday, March 26, 2021 Cornerstone Building Brands is the largest manufacturer of exterior building products in North America. Our comprehensive portfolio spans the breadth of the residential and commercial markets, while our expansive footprint enables us to serve customers and communities across North America. Our relentless focus on excellence combined with our ongoing commitment to innovation and R&D has driven us to become the #1 manufacturer of windows, vinyl siding, insulated metal panels, metal roofing and wall systems, and metal accessories. We believe every building we create, and every part of that building, positively contributes to communities where people live, work and play. Summary We are currently seeking a Human Resources Business Partner (HRBP) in our Cambridge Ohio location. HRBP's responsibilities include full-scale HR Generalist support associated with a manufacturing facility. The HRBP will be involved in the development and implementation of strategic HR programs in partnership with the plant leadership and HR teams. The role provides expertise in the areas of employee relations, workforce planning, talent acquisition, performance management, employee retention, coaching/development, conflict management and ad hoc projects, as necessary. This is an exempt day shift position; however, candidates must be flexible to provide HR assistance to multiple shift personnel. Education and Experience * Bachelor level in Human Resources, Business, or Related Degree; or equivalent work experience required. * 1+ years of progressive experience within the HR function as a business partner * Experience objectively coaching employees and management through complex, difficult and emotional issues * Experience within a unionized environment required * Demonstrated ability to interact with all levels of employees in the organization including senior leaders * Must be proficient with MS Office (MS Word, Excel, PowerPoint, and Outlook). * Excellent organizational, analytical, problem solving, interpersonal, and communication skills * Ability to collaborate in a matrix organization, prioritize and provide excellent customer service in a fast-paced environment. * An advanced related degree is a plus. Essential Functions and Responsibility * Proactively provides strategic HR partnership to assigned client groups in a manufacturing environment to achieve company goals * Work with business leaders to build cohesive working relations and ensure the effective implementation and execution of HR initiatives * Proactively identify opportunities and assess improvements to the employee experience and partner with leadership to develop and implement innovative and lasting solutions. * Serve as internal consultant and change agent by analyzing current HR programs and recommending solutions * Coach leaders on complex employee relations matters and collaborate with HR operations to ensure compliance * execute performance management programs and procedures, including but not limited to performance appraisals and performance improvement plans * Partner with the Talent Acquisition team to identify staffing requirements needed to meet the goals and objectives of the organization * Understands and solicits employee feedback and anticipates their needs and concerns * Partner with HR COEs/Shared Services to deliver leadership and employee development, talent acquisition and management, total rewards, and operational activities. * Foster a high performing and highly engaged culture Benefits Offered * Benefits start day one! * Share in the Rewards for our Performance: Quarterly Gainsharing Bonus based on the performance of our plant * Recharge: 11 Company paid Holidays, Paid Sick and vacation time * Save for the future: 401k with Company Match * Continue to learn and grow: Tuition Reimbursement, Company Training to improve your skills * Be well: Medical, Dental, Vision, Wellness programs, Employee Assistance Program, Flexible Spending Account. * Short and Long-Term disability * Paid life insurance * Refer a friend sign on bonus Cornerstone Building Brands is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of age, race, religion, color, protected veteran status, disability, sex, gender identity, sexual orientation or national origin. Recruitment Fraud We have been made aware of multiple scams whereby unauthorized individuals are using Cornerstone Building Brand's name and logo to solicit potential job-seekers for employment. In some cases, job-seekers are being contacted directly, both by phone and e-mail. In other instances, these unauthorized individuals are placing advertisements for fake positions with both legitimate websites and fabricated ones. These individuals are typically promising high-paying jobs with the requirement that the job-seeker send money to pay for things such as visa applications or processing fees. Please be advised that Cornerstone Building Brands will never ask potential job-seekers for any sort of advance payment or bank account information as part of the recruiting or hiring process. Other details * Job Family Human Resources * Pay Type Salary * Travel Required No * Required Education Equivalent Experience
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. How you will Achieve More with Intellia: As an Associate Director of Financial Planning & Analysis, you will lead business partnering across the Clinical and CMC organizations. In this highly visible role, you will be instrumental in developing best-in-class processes and building robust reporting and analytics to support the business. In this opportunity, your main responsibilities will include: Leading the overall annual budget and forecasting processes for the Clinical and CMC organiza tions Serving as a strategic business partner to our Clinical and CMC Teams delivering timely and accurate monthly reporting on key areas of the business, including analysis of actual results vs plan, key trends impacting the business and projections of future spend in alignment with the company's corporate and functional goals Preparing a monthly reporting package that includes dashboards and analysis for CFO review; including commentary for trends and variances Building analytical tools and creating reports on non-financial metrics including: Headcount, Time Allocation, Purchase commitments and others Working closely with the accounting team during the month and quarter end close to ensure adherence to timelines and compliance with SOX Controls requirements Managing and continuing to develop our planning system, Adaptive Insights Interfacing extensively with cross-functional leadership and having the opportunity to present at Executive team meetings If you enjoy working in Biotech, and are a strategic finance partner with strong Financial Planning and ERP systems experience, then this could be just the job for you! Meet your future team: This role will report directly to the Vice President, Financial Planning and Analysis. The FP&A team is made up of three other individuals, who bring a range of experience and knowledge. While a small team, you will join a group of passionate individuals who enjoying working with one another. In addition to the FP&A team, you will have the opportunity to be a part of the larger group of people under the CFO, which is comprised of: Procurement, Accounting, Payroll/Equity, IT, Investor Relations, Corporate Communications, and Operations. While the Finance team is currently working virtually, we are tentatively planning a return to the office in June. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community. This includes virtual happy hours, team all-hands meetings, game nights, and more! You can expect to join a hardworking, collaborative environment. EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
04/20/2021
Full time
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. How you will Achieve More with Intellia: As an Associate Director of Financial Planning & Analysis, you will lead business partnering across the Clinical and CMC organizations. In this highly visible role, you will be instrumental in developing best-in-class processes and building robust reporting and analytics to support the business. In this opportunity, your main responsibilities will include: Leading the overall annual budget and forecasting processes for the Clinical and CMC organiza tions Serving as a strategic business partner to our Clinical and CMC Teams delivering timely and accurate monthly reporting on key areas of the business, including analysis of actual results vs plan, key trends impacting the business and projections of future spend in alignment with the company's corporate and functional goals Preparing a monthly reporting package that includes dashboards and analysis for CFO review; including commentary for trends and variances Building analytical tools and creating reports on non-financial metrics including: Headcount, Time Allocation, Purchase commitments and others Working closely with the accounting team during the month and quarter end close to ensure adherence to timelines and compliance with SOX Controls requirements Managing and continuing to develop our planning system, Adaptive Insights Interfacing extensively with cross-functional leadership and having the opportunity to present at Executive team meetings If you enjoy working in Biotech, and are a strategic finance partner with strong Financial Planning and ERP systems experience, then this could be just the job for you! Meet your future team: This role will report directly to the Vice President, Financial Planning and Analysis. The FP&A team is made up of three other individuals, who bring a range of experience and knowledge. While a small team, you will join a group of passionate individuals who enjoying working with one another. In addition to the FP&A team, you will have the opportunity to be a part of the larger group of people under the CFO, which is comprised of: Procurement, Accounting, Payroll/Equity, IT, Investor Relations, Corporate Communications, and Operations. While the Finance team is currently working virtually, we are tentatively planning a return to the office in June. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community. This includes virtual happy hours, team all-hands meetings, game nights, and more! You can expect to join a hardworking, collaborative environment. EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Senior Manager, Business Integrated Insights; Rare Disease Company: Ipsen Biopharmaceuticals Inc. Job Description: Position Summary The Business Integrated Insights Sr. Manager - Rare Disease serves as the strategic partner to the Rare Disease Business Unit and Brand Teams by generating customer, market, and product insights derived from primary market research, secondary data analytics, and competitive intelligence. This position will be involved with the three brands in the portfolio: Increlex, Somatuline Depot (Acromegaly indication) and Palovarotene, which is preparing for potential launch. The individual in this role is expected to identify, prioritize, execute, and present the analyses needed to make strategic decisions that improve the performance of aligned brands. The role will also measure brand performance, support brand planning, and act as a key stakeholder in developing brand strategy. The Business Integrated Insights Sr. Manager - Rare Disease must have experience with a variety of measurement and research methods, strategic planning, project management, data evaluation, market research, and customer insight generation. The individual in this role will also have a strong understanding of the pharmaceutical business, pharmaceutical marketing, and the role of cross-functional brand partners. This person will interact directly with Marketing, Finance, Forecasting, Value & Access, Sales and Commercial Excellence, Medical, and Patient Services. The Business Integrated Insights Sr. Manager - Rare Disease reports to the Head of Business Integrated Insights, with dotted line reporting to the Insights Lead - Rare Disease. This is a critical role in helping the Integrated Insights team to deliver on its mission to provide not only facts and data, but insights and implications that drive growth. This role will directly contribute to the performance of the inline and launch brands in our Rare Disease portfolio and represent the voices of our stakeholders (patients and HCPs) in making critical business decisions. This is an exciting opportunity for an individual to work across in-line brands at different lifecycle stages, as well as support the potential launch of a groundbreaking new treatment. Essential Functions Responsibilities will include, but are not limited to, the following: Collaborate closely with the Integrated Insights team and cross-functional partners across the brand and business Define and manage scope of work and budget for all brand insights and analytics needs and requirements Drive business need identification, qualification, and resolution while leveraging business analytics and other data-driven resources, for example: regular reporting, advanced analytics, primary and secondary market research, customer intelligence, competitive intelligence, ROI analytics and analysis of the impact of all marketing expenditures, and field force execution Deliver effective presentations of findings and recommendations to multiple levels of leadership, creating visual displays of quantitative information Collaborate with and influence internal stakeholders to process and prioritize new insights and analytics requests, provide feedback on vendor performance, and review data quality assurance policies and procedures As appropriate, collect the forecasting inputs, elaborate on forecasting assumptions, and facilitate the forecasting process in collaboration with the Business Analytics Forecasting team Participate as a key thought leader of the business planning team by challenging assumptions and identifying key risks and opportunities Comply with all laws, regulations, and policies that govern the conduct of Ipsen U.S. staff Qualifications Education Bachelor's degree or equivalent experience required Master's degree in Business Administration or a quantitative field preferred Experience 10 years work experience / 8 years work experience with an MBA Minimum 5+ years of pharmaceuticals and life sciences experience, including at least 2 years of client-side experience in data analytics/forecasting, primary market research, and/or competitive intelligence Experience Rare Diseases preferred, but not required Vendor side experience in primary market research, data analytics, or consulting is a plus Demonstrated success using research to drive insights and strategic implications that lead to business decisions Thorough understanding of the commercialization of biopharmaceuticals, including brand management, sales planning and execution, market access, and regulatory environments Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) Ability to transition easily from data and observations to practical business considerations Ability to anticipate internal and external business challenges and recommend process, product, or service improvements High degree of creativity and innovation in developing new approaches, processes, and methodologies Clear understanding of the changing healthcare marketplace Ability to effectively perform all functions in adherence with legal, compliance, and regulatory guidelines in the pharmaceutical industry Ability to contribute to the development of functional strategy to assist business areas in defining their information strategy Significant experience in leading cross functional, matrixed project teams to achieve milestones and objectives Advanced oral and written communication, interpersonal, public relations, facilitation, management, decision making, collaboration, and organizational skills IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
04/20/2021
Full time
Title: Senior Manager, Business Integrated Insights; Rare Disease Company: Ipsen Biopharmaceuticals Inc. Job Description: Position Summary The Business Integrated Insights Sr. Manager - Rare Disease serves as the strategic partner to the Rare Disease Business Unit and Brand Teams by generating customer, market, and product insights derived from primary market research, secondary data analytics, and competitive intelligence. This position will be involved with the three brands in the portfolio: Increlex, Somatuline Depot (Acromegaly indication) and Palovarotene, which is preparing for potential launch. The individual in this role is expected to identify, prioritize, execute, and present the analyses needed to make strategic decisions that improve the performance of aligned brands. The role will also measure brand performance, support brand planning, and act as a key stakeholder in developing brand strategy. The Business Integrated Insights Sr. Manager - Rare Disease must have experience with a variety of measurement and research methods, strategic planning, project management, data evaluation, market research, and customer insight generation. The individual in this role will also have a strong understanding of the pharmaceutical business, pharmaceutical marketing, and the role of cross-functional brand partners. This person will interact directly with Marketing, Finance, Forecasting, Value & Access, Sales and Commercial Excellence, Medical, and Patient Services. The Business Integrated Insights Sr. Manager - Rare Disease reports to the Head of Business Integrated Insights, with dotted line reporting to the Insights Lead - Rare Disease. This is a critical role in helping the Integrated Insights team to deliver on its mission to provide not only facts and data, but insights and implications that drive growth. This role will directly contribute to the performance of the inline and launch brands in our Rare Disease portfolio and represent the voices of our stakeholders (patients and HCPs) in making critical business decisions. This is an exciting opportunity for an individual to work across in-line brands at different lifecycle stages, as well as support the potential launch of a groundbreaking new treatment. Essential Functions Responsibilities will include, but are not limited to, the following: Collaborate closely with the Integrated Insights team and cross-functional partners across the brand and business Define and manage scope of work and budget for all brand insights and analytics needs and requirements Drive business need identification, qualification, and resolution while leveraging business analytics and other data-driven resources, for example: regular reporting, advanced analytics, primary and secondary market research, customer intelligence, competitive intelligence, ROI analytics and analysis of the impact of all marketing expenditures, and field force execution Deliver effective presentations of findings and recommendations to multiple levels of leadership, creating visual displays of quantitative information Collaborate with and influence internal stakeholders to process and prioritize new insights and analytics requests, provide feedback on vendor performance, and review data quality assurance policies and procedures As appropriate, collect the forecasting inputs, elaborate on forecasting assumptions, and facilitate the forecasting process in collaboration with the Business Analytics Forecasting team Participate as a key thought leader of the business planning team by challenging assumptions and identifying key risks and opportunities Comply with all laws, regulations, and policies that govern the conduct of Ipsen U.S. staff Qualifications Education Bachelor's degree or equivalent experience required Master's degree in Business Administration or a quantitative field preferred Experience 10 years work experience / 8 years work experience with an MBA Minimum 5+ years of pharmaceuticals and life sciences experience, including at least 2 years of client-side experience in data analytics/forecasting, primary market research, and/or competitive intelligence Experience Rare Diseases preferred, but not required Vendor side experience in primary market research, data analytics, or consulting is a plus Demonstrated success using research to drive insights and strategic implications that lead to business decisions Thorough understanding of the commercialization of biopharmaceuticals, including brand management, sales planning and execution, market access, and regulatory environments Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) Ability to transition easily from data and observations to practical business considerations Ability to anticipate internal and external business challenges and recommend process, product, or service improvements High degree of creativity and innovation in developing new approaches, processes, and methodologies Clear understanding of the changing healthcare marketplace Ability to effectively perform all functions in adherence with legal, compliance, and regulatory guidelines in the pharmaceutical industry Ability to contribute to the development of functional strategy to assist business areas in defining their information strategy Significant experience in leading cross functional, matrixed project teams to achieve milestones and objectives Advanced oral and written communication, interpersonal, public relations, facilitation, management, decision making, collaboration, and organizational skills IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: As Director Regulatory Affairs, Oncology you will be accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products. Your role will involve: Product/Project Leadership Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs within the assigned portfolio, either directly or through the supervision of the Regulatory Team: Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics). Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets. Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Franchise, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible. With R&D, Franchise, Operations and Project Teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions. Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics. With Franchise, contribute to the definition of the appropriate strategy for the assigned product. Consider regulatory avenues to maximize intellectual property protection and data exclusivity. In collaboration with other GMRS functions ensure the establishment of CCDS and required safety plans for the assigned product. Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available. Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards). Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making. Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes. Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues. Review and input to all key documentation relevant to Franchise plans as required. Responsible for conducting regulatory due diligence assessment on external opportunities Lead operational excellence initiatives within GRA Regulatory Intelligence Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates external environment into plans. Accountable for collecting, recording and sharing of competitive regulatory information for Ipsen competitor products for the assigned disease areas within the therapeutic area. Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way Responsible for promoting activities and processes to reinforce good external influencing behaviors in the GRA organization Building Relationships with Regulators Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Communication Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). Budget Contribute towards effective planning of the GRA budget. Ethics and Compliance Accountable for ensuring all activities are conducted in line with Ipsen's ethics and compliance policies. In return, you will bring: Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Track record of building excellent relationships with FDA. Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus. Knowledge of medical device / drug device combination regulations would be a plus. Prior experience with hematological malignancies and solid tumors helpful. Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences). Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
04/20/2021
Full time
Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: As Director Regulatory Affairs, Oncology you will be accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products. Your role will involve: Product/Project Leadership Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs within the assigned portfolio, either directly or through the supervision of the Regulatory Team: Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics). Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets. Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Franchise, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible. With R&D, Franchise, Operations and Project Teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions. Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics. With Franchise, contribute to the definition of the appropriate strategy for the assigned product. Consider regulatory avenues to maximize intellectual property protection and data exclusivity. In collaboration with other GMRS functions ensure the establishment of CCDS and required safety plans for the assigned product. Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available. Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards). Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making. Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes. Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues. Review and input to all key documentation relevant to Franchise plans as required. Responsible for conducting regulatory due diligence assessment on external opportunities Lead operational excellence initiatives within GRA Regulatory Intelligence Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates external environment into plans. Accountable for collecting, recording and sharing of competitive regulatory information for Ipsen competitor products for the assigned disease areas within the therapeutic area. Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way Responsible for promoting activities and processes to reinforce good external influencing behaviors in the GRA organization Building Relationships with Regulators Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Communication Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). Budget Contribute towards effective planning of the GRA budget. Ethics and Compliance Accountable for ensuring all activities are conducted in line with Ipsen's ethics and compliance policies. In return, you will bring: Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Track record of building excellent relationships with FDA. Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus. Knowledge of medical device / drug device combination regulations would be a plus. Prior experience with hematological malignancies and solid tumors helpful. Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences). Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
You don't need a culinary degree to work with Clover (though many of your colleagues will have them). Our employees have backgrounds ranging from fast food to fine dining, from kayaking instructor to photographer, recently-graduated college student to farmer to construction worker. We're looking for people who share our love...
04/20/2021
Full time
You don't need a culinary degree to work with Clover (though many of your colleagues will have them). Our employees have backgrounds ranging from fast food to fine dining, from kayaking instructor to photographer, recently-graduated college student to farmer to construction worker. We're looking for people who share our love...
What's in it for you?. We are seeking a highly skilled and motivated scientist to join the Translational Biology Group. The primary responsibility for this position will be to develop, optimize, and validate bioanalytical assays to support late stage preclinical and clinical studies. This hire will have a significant role in contributing towards validating therapeutic potential of different drug candidates targeting the TGF-beta superfamily signaling pathway to help us achieve our goal of transforming patients' lives. What will you be doing?: Develop, optimize, and troubleshoot ligand binding, enzymatic activity, and cell-based assays using various techniques. Perform routine and non-routine analytical testing of study samples. Collecting and processing tissue samples from various animal models and humans. Assist in maintaining general laboratory functionality, including lab equipment maintenance, and ordering and receipt of lab supplies. Maintain clear, accurate written records of laboratory procedures, results and diligent and timely documentation of experiments in ELN and reports. Communicate findings with internal and external teams/partners in a clear and concise manner. What are we looking for?: S/M.S in biological sciences or related discipline. Minimum of 3 years of research experience, preferably related to drug discovery and translational sciences. Prior industry experience is a plus. Experience with proteins/antibodies and development and optimization of ligand binding assays across multiple platforms (ELISA, MSD and Luminex). Experience in RNA isolation, quantitative PCR and other RNA based technologies. Exceptional research, organizational, and communication skills (both written and oral) coupled with a strong attention to details. Experience with technology transfers of assays to CRO's is highly valuable. How will you grow with us?. It is truly an exciting time to join the Acceleron team with our robust pipeline and innovative science. As a part of the Translational and Exploratory Biology group, you will get a meaningful, hands-on experience where you will learn and expand upon your skills alongside a knowledgeable and supportive team. If you are looking for a new challenge and the opportunity to contribute to cutting-edge science, then join us!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
04/19/2021
Full time
What's in it for you?. We are seeking a highly skilled and motivated scientist to join the Translational Biology Group. The primary responsibility for this position will be to develop, optimize, and validate bioanalytical assays to support late stage preclinical and clinical studies. This hire will have a significant role in contributing towards validating therapeutic potential of different drug candidates targeting the TGF-beta superfamily signaling pathway to help us achieve our goal of transforming patients' lives. What will you be doing?: Develop, optimize, and troubleshoot ligand binding, enzymatic activity, and cell-based assays using various techniques. Perform routine and non-routine analytical testing of study samples. Collecting and processing tissue samples from various animal models and humans. Assist in maintaining general laboratory functionality, including lab equipment maintenance, and ordering and receipt of lab supplies. Maintain clear, accurate written records of laboratory procedures, results and diligent and timely documentation of experiments in ELN and reports. Communicate findings with internal and external teams/partners in a clear and concise manner. What are we looking for?: S/M.S in biological sciences or related discipline. Minimum of 3 years of research experience, preferably related to drug discovery and translational sciences. Prior industry experience is a plus. Experience with proteins/antibodies and development and optimization of ligand binding assays across multiple platforms (ELISA, MSD and Luminex). Experience in RNA isolation, quantitative PCR and other RNA based technologies. Exceptional research, organizational, and communication skills (both written and oral) coupled with a strong attention to details. Experience with technology transfers of assays to CRO's is highly valuable. How will you grow with us?. It is truly an exciting time to join the Acceleron team with our robust pipeline and innovative science. As a part of the Translational and Exploratory Biology group, you will get a meaningful, hands-on experience where you will learn and expand upon your skills alongside a knowledgeable and supportive team. If you are looking for a new challenge and the opportunity to contribute to cutting-edge science, then join us!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
Job Title: Sales AssociateReports To: Assistant Store ManagerJob Location: Store LocationFLSA Status: Hourly Non-Exempt. Positions may be Full or Part-Time; Seasonal or Non-SeasonalJOB DUTIES AND ESSENTIAL FUNCTIONS Assist customers with purchasing decisions and load outs Give consistent quality customer service ensuring a successful shopping experience Merchandise, stock, and assemble merchandise Be familiar with all advertised items and their locations Greet all customers who are within ten feet of you Practice sound safety knowledge & best practices for materials handling Maintain a clean and organized department including recovery Use general office equipment such as telephone, copy machine, fax machine, calculator, computer Operate Telxon gun, forklift, pallet jack, ladder, and other retail equipment. May be required to cross train and perform other dutiesQUALIFICATIONS Ability to interact with the team in a fast-paced environment, remaining flexible, proactive, resourceful and efficient Ability to work independently without supervision Ability to access and use the in-store computer, scanning system, and wireless handheld unit Ability to participate in our online applicant and new hire onboarding process remotely Ability to complete computer-based trainingSUPERVISORY RESPONSIBILITIES NonePHYSICAL REQUIREMENTS Good visual acuity Ability to lift, push, and/or pull a minimum of 30 pounds repetitively and 31-50 pounds intermittently Ability to stand and/or walk for long periods of time Ability to use a ladder and/or pallet jack Close vision for computer work Repetitive wrist movements on keyboard Ability to walk up and down stairs multiple times per day Ability to verbally communicate effectively and professionally with all audiences (in-person or via handheld transceiver)Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
04/19/2021
Full time
Job Title: Sales AssociateReports To: Assistant Store ManagerJob Location: Store LocationFLSA Status: Hourly Non-Exempt. Positions may be Full or Part-Time; Seasonal or Non-SeasonalJOB DUTIES AND ESSENTIAL FUNCTIONS Assist customers with purchasing decisions and load outs Give consistent quality customer service ensuring a successful shopping experience Merchandise, stock, and assemble merchandise Be familiar with all advertised items and their locations Greet all customers who are within ten feet of you Practice sound safety knowledge & best practices for materials handling Maintain a clean and organized department including recovery Use general office equipment such as telephone, copy machine, fax machine, calculator, computer Operate Telxon gun, forklift, pallet jack, ladder, and other retail equipment. May be required to cross train and perform other dutiesQUALIFICATIONS Ability to interact with the team in a fast-paced environment, remaining flexible, proactive, resourceful and efficient Ability to work independently without supervision Ability to access and use the in-store computer, scanning system, and wireless handheld unit Ability to participate in our online applicant and new hire onboarding process remotely Ability to complete computer-based trainingSUPERVISORY RESPONSIBILITIES NonePHYSICAL REQUIREMENTS Good visual acuity Ability to lift, push, and/or pull a minimum of 30 pounds repetitively and 31-50 pounds intermittently Ability to stand and/or walk for long periods of time Ability to use a ladder and/or pallet jack Close vision for computer work Repetitive wrist movements on keyboard Ability to walk up and down stairs multiple times per day Ability to verbally communicate effectively and professionally with all audiences (in-person or via handheld transceiver)Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
Amazon is looking for team members to join their warehouse in Cambridge, MA! You will be selecting, packing and shipping customer orders, full time or part time, being able to work overnight, sunrise, day, evening and weekend shifts and earn $15-17 per hour. There are several positions available, with different duties, workdays and working hours. It is an entry-level jobs, with no experience required, that you can start as soon as 7 days. Apply now and start immediately!
04/18/2021
Amazon is looking for team members to join their warehouse in Cambridge, MA! You will be selecting, packing and shipping customer orders, full time or part time, being able to work overnight, sunrise, day, evening and weekend shifts and earn $15-17 per hour. There are several positions available, with different duties, workdays and working hours. It is an entry-level jobs, with no experience required, that you can start as soon as 7 days. Apply now and start immediately!
What's in it for you?. We are seeking a highly skilled and motivated Senior Analyst, reporting to the Senior Manager, Commercial Finance, who has an accounting background, however, is eager to be involved in the finance arm of the Accounting/Finance function. As a member of the Finance team, you will interact with all levels of Company management and serve as a trusted business partner to the Company's Commercial function in conjunction with the Senior Manager. By supporting the Commercial team, you will have an opportunity to understand the strategic commercial thinking and initiatives that are unfolding around our lead product candidate and other pipeline assets. The Finance/Accounting team is a fun, collaborative, and supportive group that works diligently to achieve its goals. If you are excited to join a fast-pace and growing organization where you can gain invaluable operational exposure and contribute to the success story of Acceleron, then this role could be a great fit for you!. What will you be doing?: Active member in the financial planning and forecasting function in support of the Commercial team by assisting in the annual budget and quarterly reforecast processes. Thinks critically on the best method to generate reports that analyze budget versus actual results, and review with key internal stakeholders: Work closely with the Commercial team to understand commercial strategy and key financial metrics and collaborate with accounting to identify potential financial impacts to ensure financial data is properly recorded. Work independently on maintaining and improving financial reports/models that track and analyze functional costs and their impact on the Commercial function and overall company performance. Work strategically on various projects to assess where value-add financial information can be provided and discussed with key Commercial personnel to assist in their decision-making. Identify risks and opportunities that drive financial results and effectively communicate to Finance: Review requisitions and contracts to ensure proper coding and alignment to departments' budgets. Take ownership of key quarterly close activities such as preparing journal entries, reconciling balance sheet and P&L accounts, and performing analytical reviews: Assist in the maintenance of an effective system of controls and Sarbanes-Oxley compliance. Participate in process improvement activities including enhancing current financial processes, and leverage technology to increase effectiveness: Assisting with ad hoc projects as they may arise. What are we looking for?: Bachelor's degree in Accounting or Finance. Minimum of 5 years of progressive experience in finance and/or accounting environment, whether that is directly at a public accounting firm or an industry-specific firm. CPA preferred, but not required. Life science (pharmaceutical or biotech) experience preferred, but not required. Must possess a strong knowledge of accounting principles, including GAAP and Sarbanes-Oxley. Must possess strong analytical skills and solid business acumen. Experience with ERP systems; Oracle Fusion and Adaptive preferred. Advanced knowledge in Microsoft Excel, Word and PowerPoint are required. Attention to detail and accuracy, and ability to manage time effectively and efficiently. Strong interpersonal, verbal, and written communication skills. Ability to proactively manage competing priorities with deadlines, without sacrificing quality. Must demonstrate leadership and initiative and be able to work independently and collaboratively across the organization. Embrace our core values: Team collaboration, Accelerating drug discovery, Commitment to patients, Employee development. How will you grow with us?. Our active pipeline and fast pace provide an exciting opportunity to join a dynamic team and take on a hands-on role where you will be able to significantly contribute to the strategy and initiatives within the Finance group.We are looking for someone to bring fresh perspectives and ideas as you partner with dynamic teams, take on new challenges and grow in your career. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history.This opportunity will allow you to develop your skills by taking on new challenges and partnering with sharp and dedicated team members within the organization who will motivate and support you. Join our team and apply today!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT: .
04/18/2021
Full time
What's in it for you?. We are seeking a highly skilled and motivated Senior Analyst, reporting to the Senior Manager, Commercial Finance, who has an accounting background, however, is eager to be involved in the finance arm of the Accounting/Finance function. As a member of the Finance team, you will interact with all levels of Company management and serve as a trusted business partner to the Company's Commercial function in conjunction with the Senior Manager. By supporting the Commercial team, you will have an opportunity to understand the strategic commercial thinking and initiatives that are unfolding around our lead product candidate and other pipeline assets. The Finance/Accounting team is a fun, collaborative, and supportive group that works diligently to achieve its goals. If you are excited to join a fast-pace and growing organization where you can gain invaluable operational exposure and contribute to the success story of Acceleron, then this role could be a great fit for you!. What will you be doing?: Active member in the financial planning and forecasting function in support of the Commercial team by assisting in the annual budget and quarterly reforecast processes. Thinks critically on the best method to generate reports that analyze budget versus actual results, and review with key internal stakeholders: Work closely with the Commercial team to understand commercial strategy and key financial metrics and collaborate with accounting to identify potential financial impacts to ensure financial data is properly recorded. Work independently on maintaining and improving financial reports/models that track and analyze functional costs and their impact on the Commercial function and overall company performance. Work strategically on various projects to assess where value-add financial information can be provided and discussed with key Commercial personnel to assist in their decision-making. Identify risks and opportunities that drive financial results and effectively communicate to Finance: Review requisitions and contracts to ensure proper coding and alignment to departments' budgets. Take ownership of key quarterly close activities such as preparing journal entries, reconciling balance sheet and P&L accounts, and performing analytical reviews: Assist in the maintenance of an effective system of controls and Sarbanes-Oxley compliance. Participate in process improvement activities including enhancing current financial processes, and leverage technology to increase effectiveness: Assisting with ad hoc projects as they may arise. What are we looking for?: Bachelor's degree in Accounting or Finance. Minimum of 5 years of progressive experience in finance and/or accounting environment, whether that is directly at a public accounting firm or an industry-specific firm. CPA preferred, but not required. Life science (pharmaceutical or biotech) experience preferred, but not required. Must possess a strong knowledge of accounting principles, including GAAP and Sarbanes-Oxley. Must possess strong analytical skills and solid business acumen. Experience with ERP systems; Oracle Fusion and Adaptive preferred. Advanced knowledge in Microsoft Excel, Word and PowerPoint are required. Attention to detail and accuracy, and ability to manage time effectively and efficiently. Strong interpersonal, verbal, and written communication skills. Ability to proactively manage competing priorities with deadlines, without sacrificing quality. Must demonstrate leadership and initiative and be able to work independently and collaboratively across the organization. Embrace our core values: Team collaboration, Accelerating drug discovery, Commitment to patients, Employee development. How will you grow with us?. Our active pipeline and fast pace provide an exciting opportunity to join a dynamic team and take on a hands-on role where you will be able to significantly contribute to the strategy and initiatives within the Finance group.We are looking for someone to bring fresh perspectives and ideas as you partner with dynamic teams, take on new challenges and grow in your career. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history.This opportunity will allow you to develop your skills by taking on new challenges and partnering with sharp and dedicated team members within the organization who will motivate and support you. Join our team and apply today!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT: .
Sr Research Associate**job details:**+ location:Cambridge, MA+ salary:$39.95 - $47 per hour+ date posted:Monday, March 29, 2021+ experience:3 Years+ job type:Contract+ industry:Professional, Scientific, and Technical Services+ reference:35831**job description**Sr Research Associatejob summary:**As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!**location: Cambridge, Massachusettsjob type: Contractsalary: $39.95 - 47.00 per hourwork hours: 9 to 5education: Bachelorsresponsibilities:**OBJECTIVES/PURPOSE**- Perform analytical characterization and binding kinetics studies for potential biologics drug candidates- Operate wide range of state of art analytical and biophysical equipment in high throughput workflow- Multitask and run experiments in timeline driven matrix organization- Communicate data clearly to program team- Work collaboratively in teams with diverse expertise**ACCOUNTABILITIES ?**- Run binding kinetics experiments to understand binding affinities of potential biologics drug candidates- Support high throughput biologics protein analytics workflow to support large number of diverse programs- Generate high quality analytical data in a timely manner to enable biologics drug discovery programs- Excellent oral and written communication skills to present data in program team meetings- Excellent interpersonal skills to foster collaboration and work with colleagues from different parts of the organization**DIMENSIONS AND ASPECTS**Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)- Desirable: Operational expertise in wide range of biophysical and analytical methods:o Biacore, Octet, MSD or other binding kinetics analysiso UPLC/HPLC based methods, e.g., Size Exclusion Chromatography(SEC), Ion exchange (IEX), Reverse phase (RP), Hydrophobic interaction chromatography (HIC)o CE-SDS, cIEFo Light scattering: DLS and MALSo Thermal stability(Tm, Tagg) and protein foldingLeadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)Influence without authority: Ability to work in a team and influence team to make data driven decisionsDecision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)- Manages workload and expectations with minimum supervision- Ability to search literature and come up with innovative solution to difficult problemsInteraction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)- Team player- Work collaboratively within the functional area and across the networkInnovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)- Determines methods on new assignments; perform literature search as needed to propose innovative solutionsComplexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)qualifications:**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**- BS, MS or PhD from Science or Engineering background with 5 years of overall experience-skills: Analytical Chemistry, ChromatographyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
04/18/2021
Full time
Sr Research Associate**job details:**+ location:Cambridge, MA+ salary:$39.95 - $47 per hour+ date posted:Monday, March 29, 2021+ experience:3 Years+ job type:Contract+ industry:Professional, Scientific, and Technical Services+ reference:35831**job description**Sr Research Associatejob summary:**As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!**location: Cambridge, Massachusettsjob type: Contractsalary: $39.95 - 47.00 per hourwork hours: 9 to 5education: Bachelorsresponsibilities:**OBJECTIVES/PURPOSE**- Perform analytical characterization and binding kinetics studies for potential biologics drug candidates- Operate wide range of state of art analytical and biophysical equipment in high throughput workflow- Multitask and run experiments in timeline driven matrix organization- Communicate data clearly to program team- Work collaboratively in teams with diverse expertise**ACCOUNTABILITIES ?**- Run binding kinetics experiments to understand binding affinities of potential biologics drug candidates- Support high throughput biologics protein analytics workflow to support large number of diverse programs- Generate high quality analytical data in a timely manner to enable biologics drug discovery programs- Excellent oral and written communication skills to present data in program team meetings- Excellent interpersonal skills to foster collaboration and work with colleagues from different parts of the organization**DIMENSIONS AND ASPECTS**Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)- Desirable: Operational expertise in wide range of biophysical and analytical methods:o Biacore, Octet, MSD or other binding kinetics analysiso UPLC/HPLC based methods, e.g., Size Exclusion Chromatography(SEC), Ion exchange (IEX), Reverse phase (RP), Hydrophobic interaction chromatography (HIC)o CE-SDS, cIEFo Light scattering: DLS and MALSo Thermal stability(Tm, Tagg) and protein foldingLeadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)Influence without authority: Ability to work in a team and influence team to make data driven decisionsDecision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)- Manages workload and expectations with minimum supervision- Ability to search literature and come up with innovative solution to difficult problemsInteraction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)- Team player- Work collaboratively within the functional area and across the networkInnovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)- Determines methods on new assignments; perform literature search as needed to propose innovative solutionsComplexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)qualifications:**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**- BS, MS or PhD from Science or Engineering background with 5 years of overall experience-skills: Analytical Chemistry, ChromatographyEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
JOB PURPOSE Sana Biotechnology is seeking a creative and highly-motivated individual to join our Gene Therapy Vector Design team. This Senior Scientist will be responsible for advancing our targeted viral vector platform by applying high-throughput pooled selection methods. The candidate will collaborate with other research program teams and technology sciences groups across the company to design and engineer pooled selection strategies to meet project needs. This work will require expertise in synthetic biology, molecular biology, gene editing, viral vector biology and high-throughput screening, as well as excellent collaboration skills. DUTIES AND RESPONSIBILITIES Supervise and participate in the design, construction and testing of pooled selection strategies Collaborate with research functional leaders and program leaders to ensure that the selection strategies are designed and constructed to meet specifications, and communicate robustly with them throughout development Planning, designing and executing complex experiments Building genetic libraries of variants, using high-throughput molecular cloning methods Working closely with other members of the gene therapy, computational biology and process development teams to share and apply knowledge advancements Reviewing and presenting data cross-functionally at department meetings and larger forums. Comply with standard laboratory practices and company policies, including strict notebook documentation and biosafety policies Contribute to the overall Sana mission and culture QUALIFICATIONS Basic Qualifications PhD. in Cell Biology, Synthetic Biology, Biophysics, Molecular Biology, Bioengineering or related discipline with a minimum of 5 years of directly related experience in the academic research and/or biotech industry Publication record demonstrating proficiency in high-throughput pooled screening methods, including the generation of high-complexity combinatorial libraries Direct hands-on experience with gene and genome editing such as CRISPR-Cas9 or equivalent, lentiviral biology and/or gene therapy vector and payload design Skills in synthetic biology, genetic engineering or gene circuit design (knock-ins and knock-outs), cell biology, cloning and molecular biology Excellent bench skills with attention to detail and high standards for data integrity and quality. Must be detail oriented, self-motivated, flexible, and able to prioritize and manage several fast-paced projects concurrently Outstanding verbal and written communication skills for technical and non-technical audiences Demonstrated ability to work in cross-functional teams as a strong team player as well as independently Known for his/her/their delivery of projects within a timeframe Preferred Qualifications Experience with liquid handler automation platforms (e.g. Integra, Hamilton, Tecan) Experience working with barcoding systems and/or single cell analysis Facility with one or more programming languages, such as R or Python
04/17/2021
Full time
JOB PURPOSE Sana Biotechnology is seeking a creative and highly-motivated individual to join our Gene Therapy Vector Design team. This Senior Scientist will be responsible for advancing our targeted viral vector platform by applying high-throughput pooled selection methods. The candidate will collaborate with other research program teams and technology sciences groups across the company to design and engineer pooled selection strategies to meet project needs. This work will require expertise in synthetic biology, molecular biology, gene editing, viral vector biology and high-throughput screening, as well as excellent collaboration skills. DUTIES AND RESPONSIBILITIES Supervise and participate in the design, construction and testing of pooled selection strategies Collaborate with research functional leaders and program leaders to ensure that the selection strategies are designed and constructed to meet specifications, and communicate robustly with them throughout development Planning, designing and executing complex experiments Building genetic libraries of variants, using high-throughput molecular cloning methods Working closely with other members of the gene therapy, computational biology and process development teams to share and apply knowledge advancements Reviewing and presenting data cross-functionally at department meetings and larger forums. Comply with standard laboratory practices and company policies, including strict notebook documentation and biosafety policies Contribute to the overall Sana mission and culture QUALIFICATIONS Basic Qualifications PhD. in Cell Biology, Synthetic Biology, Biophysics, Molecular Biology, Bioengineering or related discipline with a minimum of 5 years of directly related experience in the academic research and/or biotech industry Publication record demonstrating proficiency in high-throughput pooled screening methods, including the generation of high-complexity combinatorial libraries Direct hands-on experience with gene and genome editing such as CRISPR-Cas9 or equivalent, lentiviral biology and/or gene therapy vector and payload design Skills in synthetic biology, genetic engineering or gene circuit design (knock-ins and knock-outs), cell biology, cloning and molecular biology Excellent bench skills with attention to detail and high standards for data integrity and quality. Must be detail oriented, self-motivated, flexible, and able to prioritize and manage several fast-paced projects concurrently Outstanding verbal and written communication skills for technical and non-technical audiences Demonstrated ability to work in cross-functional teams as a strong team player as well as independently Known for his/her/their delivery of projects within a timeframe Preferred Qualifications Experience with liquid handler automation platforms (e.g. Integra, Hamilton, Tecan) Experience working with barcoding systems and/or single cell analysis Facility with one or more programming languages, such as R or Python
About Omega Therapeutics: Omega Therapeutics is a privately held, development-stage biotechnology company leveraging its proprietary epigenomic programming platform to biologically engineer a new class of programmable epigenetic medicines, known as Omega Epigenomic Controllers. Using these epigenomic controllers, Omega is seeking to transform the practice of human medicine through highly selective and direct control of the human genome to treat and cure disease. Omega Therapeutics leverages its pioneering Epigenomic Programming™ platform to identify novel targets, develop first-in-class programmable epigenetic medicines, and enable rational drug development and manufacturing. Omega examines Insulated Genomic Domains (IGDs), the three-dimensional architecture of the human genome and its accompanying regulators and has identified and classified thousands of genomic "zip codes" across the ~15,000 IGDs as new drug targets. Omega's new class of medicine, called Omega Epigenomic Controllers™, modulate IGDs using therapeutics that can be programmed to precisely up or down regulate single or multi-gene expression with controlled durability. These epigenomic controllers intervene at the pre-transcriptional level and they function without altering the native human genetic code or nucleic acid sequences. Using a rational and robust target identification and validation process, enhanced by a strong computational and data driven foundation, Omega is able to efficiently design and optimize potential epigenomic controllers from its platform. This entirely new and breakthrough approach allows the Company's product candidates to also drug previously 'undruggable' targets across a broad range of diseases. The Company is strategically pursuing specific disease targets that have not been successfully addressed through conventional modalities, including certain oncology indications, liver disease, serious inflammatory conditions, and acute respiratory distress syndrome (ARDS) among others. Omega's mission is to deliver the transformative therapies of tomorrow. About the Role: Omega Therapeutics, Inc. is seeking a Director/Associate Director, Supply Chain ( commensurate with experience) to join our Technical Operations team. Reporting to the VP and Head, Technical Operations, this role leads a team responsible for establishing, implementing and managing supply chain activities within the organization and across a network of external vendors used for the clinical supply of Omega's portfolio of products. This role will drive the activities leading to the implementation of clinical inventory management and distribution systems consistent with meeting cGMP and cGCP, clinical development programs and corporate objectives. He/She will be responsible for the management of vendors including performance metrics and contractual agreements and manage clinical supplies documentation. The Director/Assoc. Director, Supply Chain works with a minimal level of supervision that will support programs and protocols; label creation, labelling activities, shipment and drug return logistical operation by interacting with internal and external customers and suppliers in order to accomplish project objectives. Key Responsibilities: Work actively and align with Clinical Operation/Study team to create forecast for each study and program including enrollment rate Support country logistics for shipping and importation Responsible for developing and formalizing robust processes/procedures related to Clinical Supply Chain activities in compliance with global regulations Develop an Inventory strategy per program, study and region Regularly monitor drug expiry and the appropriate inventory re-supply Monitoring of enrolment, drop-out rates and actual supply needs; ensure continuous re-assessment of Project needs Responsible for the sourcing of comparators and matching placebo as needed Design, develop, implement and drive processes for label creation and approvals, including translations for all countries Capable of developing a budget for each study Develop and support a vendor management process including Vendor selection for each program/study, RFP and SOWs with vendors; develop and support the governance process with external vendors Work with vendors to generate inventory reports and regularly review budget and spending Support of regulatory filings including IND submission information Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards Design, implement and oversee return and destruction of IMPs from sites Hire, train, mentor and retain Supply Chain team; plan, direct and monitor work activities such that goals and objectives are accomplished efficiently, completely within established timeframes and compliance Required Skills: Complete and advanced understanding cGMP and cGCP requirements for clinical supply chain Strong leadership skills; demonstrated ability to lead a team and influence at all levels of the organization Ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion Strong analytical, problem solving and critical thinking skills Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners Required Qualifications: Bachelor's degree in scientific/pharmacy field A minimum 12+ years of leadership experience in Clinical Supply and Supply Chain operations required, along with strong understanding of cGMP and cGCP practices Comprehensive knowledge of IRT design for control of drug distribution and inventory management Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance Strong understanding for IMP QP requirements Experience in managing third-party clinical supply operations Experience in building and managing inventory management systems Experience in building and managing strong teams Available to travel if/when needed
04/16/2021
Full time
About Omega Therapeutics: Omega Therapeutics is a privately held, development-stage biotechnology company leveraging its proprietary epigenomic programming platform to biologically engineer a new class of programmable epigenetic medicines, known as Omega Epigenomic Controllers. Using these epigenomic controllers, Omega is seeking to transform the practice of human medicine through highly selective and direct control of the human genome to treat and cure disease. Omega Therapeutics leverages its pioneering Epigenomic Programming™ platform to identify novel targets, develop first-in-class programmable epigenetic medicines, and enable rational drug development and manufacturing. Omega examines Insulated Genomic Domains (IGDs), the three-dimensional architecture of the human genome and its accompanying regulators and has identified and classified thousands of genomic "zip codes" across the ~15,000 IGDs as new drug targets. Omega's new class of medicine, called Omega Epigenomic Controllers™, modulate IGDs using therapeutics that can be programmed to precisely up or down regulate single or multi-gene expression with controlled durability. These epigenomic controllers intervene at the pre-transcriptional level and they function without altering the native human genetic code or nucleic acid sequences. Using a rational and robust target identification and validation process, enhanced by a strong computational and data driven foundation, Omega is able to efficiently design and optimize potential epigenomic controllers from its platform. This entirely new and breakthrough approach allows the Company's product candidates to also drug previously 'undruggable' targets across a broad range of diseases. The Company is strategically pursuing specific disease targets that have not been successfully addressed through conventional modalities, including certain oncology indications, liver disease, serious inflammatory conditions, and acute respiratory distress syndrome (ARDS) among others. Omega's mission is to deliver the transformative therapies of tomorrow. About the Role: Omega Therapeutics, Inc. is seeking a Director/Associate Director, Supply Chain ( commensurate with experience) to join our Technical Operations team. Reporting to the VP and Head, Technical Operations, this role leads a team responsible for establishing, implementing and managing supply chain activities within the organization and across a network of external vendors used for the clinical supply of Omega's portfolio of products. This role will drive the activities leading to the implementation of clinical inventory management and distribution systems consistent with meeting cGMP and cGCP, clinical development programs and corporate objectives. He/She will be responsible for the management of vendors including performance metrics and contractual agreements and manage clinical supplies documentation. The Director/Assoc. Director, Supply Chain works with a minimal level of supervision that will support programs and protocols; label creation, labelling activities, shipment and drug return logistical operation by interacting with internal and external customers and suppliers in order to accomplish project objectives. Key Responsibilities: Work actively and align with Clinical Operation/Study team to create forecast for each study and program including enrollment rate Support country logistics for shipping and importation Responsible for developing and formalizing robust processes/procedures related to Clinical Supply Chain activities in compliance with global regulations Develop an Inventory strategy per program, study and region Regularly monitor drug expiry and the appropriate inventory re-supply Monitoring of enrolment, drop-out rates and actual supply needs; ensure continuous re-assessment of Project needs Responsible for the sourcing of comparators and matching placebo as needed Design, develop, implement and drive processes for label creation and approvals, including translations for all countries Capable of developing a budget for each study Develop and support a vendor management process including Vendor selection for each program/study, RFP and SOWs with vendors; develop and support the governance process with external vendors Work with vendors to generate inventory reports and regularly review budget and spending Support of regulatory filings including IND submission information Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards Design, implement and oversee return and destruction of IMPs from sites Hire, train, mentor and retain Supply Chain team; plan, direct and monitor work activities such that goals and objectives are accomplished efficiently, completely within established timeframes and compliance Required Skills: Complete and advanced understanding cGMP and cGCP requirements for clinical supply chain Strong leadership skills; demonstrated ability to lead a team and influence at all levels of the organization Ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion Strong analytical, problem solving and critical thinking skills Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners Required Qualifications: Bachelor's degree in scientific/pharmacy field A minimum 12+ years of leadership experience in Clinical Supply and Supply Chain operations required, along with strong understanding of cGMP and cGCP practices Comprehensive knowledge of IRT design for control of drug distribution and inventory management Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance Strong understanding for IMP QP requirements Experience in managing third-party clinical supply operations Experience in building and managing inventory management systems Experience in building and managing strong teams Available to travel if/when needed
trustaff is currently seeking an experienced OR Registered Nurse for a 13-week travel contract. The Operating Room Nurse (OR RN) will be responsible for patient care in the preoperative, intraoperative, and postoperative phases of a patient's surgical experience. Duties of the Operating Room Nurse include patient education, circulating and/or scrubbing, and working closely with surgeons, anesthesiologists, and surgical technologists during and after surgical procedures. 1+ year of recent operating room experience is required *Most travel contracts include: - 13-week contracts - Multiple Shifts Available; Days & Nights - Guaranteed Hours Since 2002, trustaff has specialized in matching skilled healthcare professionals like you with high-paying jobs at the best facilities all across the country. As one of the nation's leading travel nursing agencies, not only are trustaff's travel nurses some of the highest-paid in the industry, you'll enjoy great employee benefits, premier access to hundreds of jobs, and unmatched personal service. Here are just some of the top-tier benefits you'll enjoy while traveling with trustaff: - Great selection of jobs - All 50 states, all specialties and modalities - Great pay - Earn as much as $2,800 per week depending on your specialty and experience! - Weekly pay through direct deposit - Guaranteed hours - Medical/Dental/Vision insurance - Health insurance options start at just $23 a week! - 24/7 service, including personal support from your recruiter, travel advocate, and clinical liaison - 401k with employer match - Assistance with travel and planning - Licensure reimbursement - Exclusive employee discount program - Earn great bonuses & refer your friends Minimum Requirements: - 1+ years recent specialty experience - Must have active RN license - Must have current BLS & ACLS
04/16/2021
Contractor
trustaff is currently seeking an experienced OR Registered Nurse for a 13-week travel contract. The Operating Room Nurse (OR RN) will be responsible for patient care in the preoperative, intraoperative, and postoperative phases of a patient's surgical experience. Duties of the Operating Room Nurse include patient education, circulating and/or scrubbing, and working closely with surgeons, anesthesiologists, and surgical technologists during and after surgical procedures. 1+ year of recent operating room experience is required *Most travel contracts include: - 13-week contracts - Multiple Shifts Available; Days & Nights - Guaranteed Hours Since 2002, trustaff has specialized in matching skilled healthcare professionals like you with high-paying jobs at the best facilities all across the country. As one of the nation's leading travel nursing agencies, not only are trustaff's travel nurses some of the highest-paid in the industry, you'll enjoy great employee benefits, premier access to hundreds of jobs, and unmatched personal service. Here are just some of the top-tier benefits you'll enjoy while traveling with trustaff: - Great selection of jobs - All 50 states, all specialties and modalities - Great pay - Earn as much as $2,800 per week depending on your specialty and experience! - Weekly pay through direct deposit - Guaranteed hours - Medical/Dental/Vision insurance - Health insurance options start at just $23 a week! - 24/7 service, including personal support from your recruiter, travel advocate, and clinical liaison - 401k with employer match - Assistance with travel and planning - Licensure reimbursement - Exclusive employee discount program - Earn great bonuses & refer your friends Minimum Requirements: - 1+ years recent specialty experience - Must have active RN license - Must have current BLS & ACLS
What's in it for you?. The Clinical Research Coordinator will be an individual responsible for supporting Clinical Operations Team members with project-specific support related to the conduct of clinical trials activities. As a Clinical Research Coordinator, you will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. What will you be doing?: Provides Clinical Operations Team members with administrative and project-specific support related to the conduct of clinical trials. Responsible for maintaining clinical study trackers. Adheres to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines. Helps coordinate and contributes to reviewing study documents. Helps coordinate project team meetings, agenda & minutes. Helps coordinate distribution of clinical trial supplies. Assists in supporting review of clinical trial data. Assists with auditing and maintaining TMF. Verifies and tracks invoices. Tracks the collection, shipment, and analysis of clinical samples. Attending study team and department meetings while assisting with meeting logistics (scheduling, room and equipment set up, attendance tracking), agenda preparation, draft meeting minutes, and collating materials for meetings. Developing an understanding of clinical trial research through exposure to research protocols, the drug development process, clinical meetings, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCP). What are we looking for?: Bachelor's Degree or equivalent experience. 1-2 years of experience working in academic study center, pharmaceutical/biotechnology or CRO organization. Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint). Ability to work independently and excellent written communication, oral communication, and organizational skills are required. Ability to work on multiple clinical projects and manage priorities effectively. Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility. Minimal travel required. How will you grow with us?. As a member of the Clinical Operations team during this time of dynamic growth, you will directly impact the success of multiple programs. This role provides a tremendous opportunity to gain experience in clinical development in a dynamic, fast-paced, and innovative company. Join our team and help us in our mission of transforming the lives of patients!.
04/15/2021
Full time
What's in it for you?. The Clinical Research Coordinator will be an individual responsible for supporting Clinical Operations Team members with project-specific support related to the conduct of clinical trials activities. As a Clinical Research Coordinator, you will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. What will you be doing?: Provides Clinical Operations Team members with administrative and project-specific support related to the conduct of clinical trials. Responsible for maintaining clinical study trackers. Adheres to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines. Helps coordinate and contributes to reviewing study documents. Helps coordinate project team meetings, agenda & minutes. Helps coordinate distribution of clinical trial supplies. Assists in supporting review of clinical trial data. Assists with auditing and maintaining TMF. Verifies and tracks invoices. Tracks the collection, shipment, and analysis of clinical samples. Attending study team and department meetings while assisting with meeting logistics (scheduling, room and equipment set up, attendance tracking), agenda preparation, draft meeting minutes, and collating materials for meetings. Developing an understanding of clinical trial research through exposure to research protocols, the drug development process, clinical meetings, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCP). What are we looking for?: Bachelor's Degree or equivalent experience. 1-2 years of experience working in academic study center, pharmaceutical/biotechnology or CRO organization. Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint). Ability to work independently and excellent written communication, oral communication, and organizational skills are required. Ability to work on multiple clinical projects and manage priorities effectively. Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility. Minimal travel required. How will you grow with us?. As a member of the Clinical Operations team during this time of dynamic growth, you will directly impact the success of multiple programs. This role provides a tremendous opportunity to gain experience in clinical development in a dynamic, fast-paced, and innovative company. Join our team and help us in our mission of transforming the lives of patients!.
On the way to become a high-throughput wizard! The scale-up team at Arbor Biotechnologies is looking for a senior Research Associate, (Sr. RA), interested in applying technologies to make biology high-throughput. Our team is leveraging technologies, such as automation and microfluidics, to increase productivity and consistency of labor-intensive biological processes, and to provide high-throughput core service for other groups in the Arbor. The Senior Research Associate, Automation & NGS, will have a rare opportunity to make a broad impact on Arbor's critical path and overall productivity. This role will have an exposure to different projects, interact with different teams, and operate different instruments. The main responsibility of the Sr. RA is to provide NGS core service to many internal teams using lab automation equipment. Other responsibilities are to develop, optimize, and trouble-shoot high-throughput protocols and write Standard Operation Procedures (SOP). The successful candidates will bring their hands-on experience in molecular biology, automation, programming, and a continued desire to learn additional skills. Successful applicants will have demonstrated skills in executing a protocol with an eye to find its weaknesses and provide suggestions. Key Responsibilities: Operates lab automation equipment and conducts laboratory experiments following a protocol with limited guidance Trouble shoots and provides feedback to update protocols; write SOPs Evaluates and summarizes results, prepares electronic lab notebook, reports, and presents data; Write and modify protocols of lab automation equipment, such as liquid handlers; Cross-team communication and training Other duties as assigned Bachelor's degree in biology, bio-engineering, or a related life science with 3+ years relevant industry experience, or Master's degree in biology, engineering or related life science with 2+ years of relevant experience. Skills Hands-on experience in molecular biology: Cloning, Transfection, Next Generation Sequencing (NGS), NGS library preparation, library construction, PCR, DNA purification Interest to learn and tinker with instruments Able to troubleshoot problems, determine causes, interact with technical support, and fix problems if possible Ability to work well in a highly cross-functional, and fast-paced team environment, and a mentality to collaborate and serve others. Exercises good time management and prioritization skills Familiar with Office Suite or Google GSuite, especially Excel, Word, PowerPoint Great verbal and writing skills Self-motivated and hard-working Preferred Qualifications: Hands-on experience to operate and program liquid handlers Work experience in a high-throughput screening facility Familiar with programming language such as Python Familiar with library Information Management System (LIMS) About Arbor: Arbor Biotechnologies is a venture-backed startup based in Cambridge, MA, composed of a small team of scientists and engineers pushing the boundaries of discovery at the intersection of computer science and biotechnology. Using our diverse backgrounds ranging from machine learning to genome engineering to protein biochemistry, we are building a platform to uncover and characterize nature's inventions on an unprecedented scale to generate impactful applications in human health and sustainability. We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional. Arbor Biotechnologies is proud to be an inclusive workplace and an Equal Opportunity Employer. recblid bldveq8n7ak2xg4gwq3cc9dx37mhnn
04/15/2021
Full time
On the way to become a high-throughput wizard! The scale-up team at Arbor Biotechnologies is looking for a senior Research Associate, (Sr. RA), interested in applying technologies to make biology high-throughput. Our team is leveraging technologies, such as automation and microfluidics, to increase productivity and consistency of labor-intensive biological processes, and to provide high-throughput core service for other groups in the Arbor. The Senior Research Associate, Automation & NGS, will have a rare opportunity to make a broad impact on Arbor's critical path and overall productivity. This role will have an exposure to different projects, interact with different teams, and operate different instruments. The main responsibility of the Sr. RA is to provide NGS core service to many internal teams using lab automation equipment. Other responsibilities are to develop, optimize, and trouble-shoot high-throughput protocols and write Standard Operation Procedures (SOP). The successful candidates will bring their hands-on experience in molecular biology, automation, programming, and a continued desire to learn additional skills. Successful applicants will have demonstrated skills in executing a protocol with an eye to find its weaknesses and provide suggestions. Key Responsibilities: Operates lab automation equipment and conducts laboratory experiments following a protocol with limited guidance Trouble shoots and provides feedback to update protocols; write SOPs Evaluates and summarizes results, prepares electronic lab notebook, reports, and presents data; Write and modify protocols of lab automation equipment, such as liquid handlers; Cross-team communication and training Other duties as assigned Bachelor's degree in biology, bio-engineering, or a related life science with 3+ years relevant industry experience, or Master's degree in biology, engineering or related life science with 2+ years of relevant experience. Skills Hands-on experience in molecular biology: Cloning, Transfection, Next Generation Sequencing (NGS), NGS library preparation, library construction, PCR, DNA purification Interest to learn and tinker with instruments Able to troubleshoot problems, determine causes, interact with technical support, and fix problems if possible Ability to work well in a highly cross-functional, and fast-paced team environment, and a mentality to collaborate and serve others. Exercises good time management and prioritization skills Familiar with Office Suite or Google GSuite, especially Excel, Word, PowerPoint Great verbal and writing skills Self-motivated and hard-working Preferred Qualifications: Hands-on experience to operate and program liquid handlers Work experience in a high-throughput screening facility Familiar with programming language such as Python Familiar with library Information Management System (LIMS) About Arbor: Arbor Biotechnologies is a venture-backed startup based in Cambridge, MA, composed of a small team of scientists and engineers pushing the boundaries of discovery at the intersection of computer science and biotechnology. Using our diverse backgrounds ranging from machine learning to genome engineering to protein biochemistry, we are building a platform to uncover and characterize nature's inventions on an unprecedented scale to generate impactful applications in human health and sustainability. We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional. Arbor Biotechnologies is proud to be an inclusive workplace and an Equal Opportunity Employer. recblid bldveq8n7ak2xg4gwq3cc9dx37mhnn
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. RESPONSIBILITIES: Work with General Counsel, other executive management, the board of directors, and legal and finance teams to manage corporate, governance, including SEC reporting requirements, and compliance matters for Intellia, including Prepare, organize and file resolutions, annual reports, appointments, powers of attorney and other statutory filings or documents. Coordinate and prepare materials for the board of directors and its committees' meetings, as well as annual shareholder meetings, including agendas, resolutions, minutes, scripts and other documentation as requested. Help with the meetings' logistics. Coordinate, prepare and maintain meeting material books and the board of directors' online portal. Maintain accurate and current officer, director and corporate governance information on Intellia's websites. Prepare and maintain director and officer agreements, questionnaires (including D&O Questionnaires), forms and information charts. Assist with officer and director onboarding and offboarding. Assist with preparing, and managing compliance with, Intellia's Code of Business Conduct and Ethics and other corporate policies, including insider trading policy and pre-clearance approvals, and maintain appropriate records. Assist with M&A, collaborations arrangements and financings by preparing due diligence and closing materials and related corporate files. Support the preparation of calendars for board, committee and shareholder meetings and compliance with SEC and Nasdaq reporting obligations, including Form 8-Ks, proxy statements, registration statements and annual and quarterly reports, to ensure timely completion. Help prepare SEC and Nasdaq related documents and filings as requested. Manage and populate the Section 16 online filing system (Computershare). Prepare and file Forms 3, 4 and 5 via Computershare, maintain SEC filing codes, and assists new officers and directors with obtaining Section 16 filing codes. Assist the company's accounting firms by providing documentation and reports relating to audits, due diligence requests and SEC filings. Stay current and help educate management and the finance and legal teams on new regulatory requirements and corporate best practices. Assist in researching SEC law, Nasdaq rules and Massachusetts corporate law. Provides information to and coordinates with other departments as requested. Help with other general corporate and legal matters, as requested. QUALIFICATIONS: At least 5 years of experience as a corporate governance paralegal or similar function in the legal department of publicly traded companies, preferably in the biotechnology/pharmaceutical industry, or at a law firm. Paralegal degree or certification, or legal degree preferred. Demonstrated understanding of handling confidential or sensitive matters. Demonstrated ability to handle a wide variety of corporate matters and excellent understanding of requirements, processes and procedures related to Corporate Secretary function, including corporate governance and SEC reporting. Ability to manage duties and additional projects assigned within specified timeframes with little to no supervision. Sound business judgment; strategic and analytical thinking. Self-motivated, flexible and interested in working on a wide range of legal, governance and compliance matters. Experience working with board of directors, senior management and cross-functional teams with a demonstrated ability to effectively communicate and manage governance requirements. Excellent organizational skills and able to work independently or with a team, as necessary, to meet critical deadlines; flexible and capable of managing multiple projects simultaneously. COMPETENCIES: Knowledge of corporate governance requirements Attention to details Exceptional time management Effective communication skills (oral and written) Intermediate or advanced skills in Microsoft Office suite of tools ((Word, Excel, PowerPoint, Visio, Project, Access, SharePoint, etc.) and Diligent Boards EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
04/15/2021
Full time
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. RESPONSIBILITIES: Work with General Counsel, other executive management, the board of directors, and legal and finance teams to manage corporate, governance, including SEC reporting requirements, and compliance matters for Intellia, including Prepare, organize and file resolutions, annual reports, appointments, powers of attorney and other statutory filings or documents. Coordinate and prepare materials for the board of directors and its committees' meetings, as well as annual shareholder meetings, including agendas, resolutions, minutes, scripts and other documentation as requested. Help with the meetings' logistics. Coordinate, prepare and maintain meeting material books and the board of directors' online portal. Maintain accurate and current officer, director and corporate governance information on Intellia's websites. Prepare and maintain director and officer agreements, questionnaires (including D&O Questionnaires), forms and information charts. Assist with officer and director onboarding and offboarding. Assist with preparing, and managing compliance with, Intellia's Code of Business Conduct and Ethics and other corporate policies, including insider trading policy and pre-clearance approvals, and maintain appropriate records. Assist with M&A, collaborations arrangements and financings by preparing due diligence and closing materials and related corporate files. Support the preparation of calendars for board, committee and shareholder meetings and compliance with SEC and Nasdaq reporting obligations, including Form 8-Ks, proxy statements, registration statements and annual and quarterly reports, to ensure timely completion. Help prepare SEC and Nasdaq related documents and filings as requested. Manage and populate the Section 16 online filing system (Computershare). Prepare and file Forms 3, 4 and 5 via Computershare, maintain SEC filing codes, and assists new officers and directors with obtaining Section 16 filing codes. Assist the company's accounting firms by providing documentation and reports relating to audits, due diligence requests and SEC filings. Stay current and help educate management and the finance and legal teams on new regulatory requirements and corporate best practices. Assist in researching SEC law, Nasdaq rules and Massachusetts corporate law. Provides information to and coordinates with other departments as requested. Help with other general corporate and legal matters, as requested. QUALIFICATIONS: At least 5 years of experience as a corporate governance paralegal or similar function in the legal department of publicly traded companies, preferably in the biotechnology/pharmaceutical industry, or at a law firm. Paralegal degree or certification, or legal degree preferred. Demonstrated understanding of handling confidential or sensitive matters. Demonstrated ability to handle a wide variety of corporate matters and excellent understanding of requirements, processes and procedures related to Corporate Secretary function, including corporate governance and SEC reporting. Ability to manage duties and additional projects assigned within specified timeframes with little to no supervision. Sound business judgment; strategic and analytical thinking. Self-motivated, flexible and interested in working on a wide range of legal, governance and compliance matters. Experience working with board of directors, senior management and cross-functional teams with a demonstrated ability to effectively communicate and manage governance requirements. Excellent organizational skills and able to work independently or with a team, as necessary, to meet critical deadlines; flexible and capable of managing multiple projects simultaneously. COMPETENCIES: Knowledge of corporate governance requirements Attention to details Exceptional time management Effective communication skills (oral and written) Intermediate or advanced skills in Microsoft Office suite of tools ((Word, Excel, PowerPoint, Visio, Project, Access, SharePoint, etc.) and Diligent Boards EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Black Diamond Therapeutics, Inc.
Cambridge, Massachusetts
Overview Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company's proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations. Director of Corporate Strategy & Business Development at Black Diamond will be responsible for defining, finding, and executing on value creating partnerships to strengthen our therapeutic pipeline and bolster our growing arsenal of cutting-edge drug discovery technology suite. The candidate will work closely with the R&D team to 1) develop strategy to position company's internal pipeline and platform technology, 2) evaluate and negotiate potential partnerships through to deal signing, 3) develop and position potential value creating new venture concepts. This Director of Corporate Strategy & Business Development position will report to the Chief Business Officer. Responsibilities Closely collaborate with R&D and finance leadership to conduct scientific, commercial and market assessments for pipeline products and BD opportunities Identifying and prioritizing external opportunities that support Black Diamond's R&D strategy and nurture scientific and business relationships Developing and maintaining competitive landscape to guide strategy and prioritize actionable business development opportunities through a strong understanding of disease biology, treatment paradigms, and emerging trends in targeted oncology therapy Triaging most compelling opportunities for further internal review based on quality of the science, commercial opportunity and the fit with strategy. Leading due diligence teams to evaluate external therapeutic programs, including risks associated with clinical and regulatory pathways, manufacturing, and commercialization of the product opportunities Developing and recommending proposed deal structures and financial terms, and leading negotiations of term sheets and contracts with potential partners in collaboration with Legal and Finance Managing on-going partnership and alliance activities, including the tracking, documentation and status reporting of all collaborations along the business development pipeline. Representing Black Diamond at some scientific conferences and key partnering events Qualifications Advanced science degree required (e.g. PhD, MD, PharmD, MS); degree in business or legal (e.g. MBA, JD) is helpful but not required 4 or more years of experience supporting business development, licensing, mergers & acquisition in innovative life science companies (Pharma and/or Biotech) Prior consulting/investment banking experience as well as R&D or project management roles are highly valued Advanced understanding of scientific and clinical data and a passion for staying abreast of the latest advancements in targeted oncology therapies Energetic, team oriented, self-motivating individual with strong analytical and solid understanding of business strategy Superb verbal and written communication skills, with an ability to influence decision making and manage stakeholders Proven ability to work effectively with project teams in a matrix environment Highly organized with excellent follow-up abilities and able to manage multiple projects and priorities Work Environment : This job operates in a professional office and lab environment. This role routinely uses standard office equipment. Physical Demands : The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs. Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
04/15/2021
Full time
Overview Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company's proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations. Director of Corporate Strategy & Business Development at Black Diamond will be responsible for defining, finding, and executing on value creating partnerships to strengthen our therapeutic pipeline and bolster our growing arsenal of cutting-edge drug discovery technology suite. The candidate will work closely with the R&D team to 1) develop strategy to position company's internal pipeline and platform technology, 2) evaluate and negotiate potential partnerships through to deal signing, 3) develop and position potential value creating new venture concepts. This Director of Corporate Strategy & Business Development position will report to the Chief Business Officer. Responsibilities Closely collaborate with R&D and finance leadership to conduct scientific, commercial and market assessments for pipeline products and BD opportunities Identifying and prioritizing external opportunities that support Black Diamond's R&D strategy and nurture scientific and business relationships Developing and maintaining competitive landscape to guide strategy and prioritize actionable business development opportunities through a strong understanding of disease biology, treatment paradigms, and emerging trends in targeted oncology therapy Triaging most compelling opportunities for further internal review based on quality of the science, commercial opportunity and the fit with strategy. Leading due diligence teams to evaluate external therapeutic programs, including risks associated with clinical and regulatory pathways, manufacturing, and commercialization of the product opportunities Developing and recommending proposed deal structures and financial terms, and leading negotiations of term sheets and contracts with potential partners in collaboration with Legal and Finance Managing on-going partnership and alliance activities, including the tracking, documentation and status reporting of all collaborations along the business development pipeline. Representing Black Diamond at some scientific conferences and key partnering events Qualifications Advanced science degree required (e.g. PhD, MD, PharmD, MS); degree in business or legal (e.g. MBA, JD) is helpful but not required 4 or more years of experience supporting business development, licensing, mergers & acquisition in innovative life science companies (Pharma and/or Biotech) Prior consulting/investment banking experience as well as R&D or project management roles are highly valued Advanced understanding of scientific and clinical data and a passion for staying abreast of the latest advancements in targeted oncology therapies Energetic, team oriented, self-motivating individual with strong analytical and solid understanding of business strategy Superb verbal and written communication skills, with an ability to influence decision making and manage stakeholders Proven ability to work effectively with project teams in a matrix environment Highly organized with excellent follow-up abilities and able to manage multiple projects and priorities Work Environment : This job operates in a professional office and lab environment. This role routinely uses standard office equipment. Physical Demands : The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs. Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
This is a front desk admin opening with a manufacturing company. This individual will be the face of the company in this role answering phone and greeting customer/vendors. This is a fast paced position and looking for the right candidate who knows how to prioritize tasks.Duties:+ Answer phone calls promptly, and direct to the correct individual/department as necessary+ Submit labor entry cards for 170 internal employees in software system (repetitive task that can take up to 2+ hours per day)+ Answer questions from employees about PTO, switching 401k/benefits info and referring to HR if it's something they cannot address+ Basic data entry tasking in Microsoft Excel+ Administrative duties to help HR in down time**About Aerotek:**We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
04/15/2021
Full time
This is a front desk admin opening with a manufacturing company. This individual will be the face of the company in this role answering phone and greeting customer/vendors. This is a fast paced position and looking for the right candidate who knows how to prioritize tasks.Duties:+ Answer phone calls promptly, and direct to the correct individual/department as necessary+ Submit labor entry cards for 170 internal employees in software system (repetitive task that can take up to 2+ hours per day)+ Answer questions from employees about PTO, switching 401k/benefits info and referring to HR if it's something they cannot address+ Basic data entry tasking in Microsoft Excel+ Administrative duties to help HR in down time**About Aerotek:**We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Regulatory Affairs Manager III**job details:**+ location:Cambridge, MA+ salary:$71.86 - $84.55 per hour+ date posted:Tuesday, April 13, 2021+ experience:7 Years+ job type:Contract+ industry:Professional, Scientific, and Technical Services+ reference:36020**job description**Regulatory Affairs Manager IIIjob summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!location: Cambridge, Massachusettsjob type: Contractsalary: $71.86 - 84.55 per hourwork hours: 9 to 5education: Bachelorsresponsibilities:The Global Regulatory CMC Early Development Lead, Gene Therapy is responsible for the line management of the team members reporting into him/her, with responsibilities for early stage of development activities for the gene therapy products portfolio. The Global Regulatory CMC Development Lead assigns projects to the team members, supports the team members in setting regulatory CMC strategies and their daily work. He/she ensures coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities. The Global Regulatory CMC Development Lead also acts as Global Reg CMC Lead for assigned programs as needed.This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development gene therapy programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific gene therapy programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program. The role is also responsible to support the evaluation of business development activities including due diligence.The CMC GRL provides regulatory CMC leadership on the cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices and/or supports PDCs.This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required.1) Accountable for line management and development of direct reports.2) Developing soft and technical skills, ensuring coaching and mentoring of the assigned team, and conduct performance assessment.3) Managing team resources efficiently - ensure proper resources allocation, enhance knowledge sharing and support the team to prioritize activities.4) Ensure the development of the Global RegCMC team members by identifying challenging objectives and enhance team visibility as key experts in submissions excellence (including Health Authority interaction and influence).5) Participate in technical and soft skill development, coaching, and performance feedback of the people working in Global RegCMC community, if requested by their management.6) As part of Global RegCMC, participate in the development of working processes and activities to increase the efficiency within Global RegCMC function.7) Accountable for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions.8) Ensures that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.9) Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.10) Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.11) Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.12) Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.13) Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.14) Facilitates capture and communication (within and outside of Global RegCMC) of CMC lessons learned from major submissions for assigned projects/products.15) Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions.16) Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products.17) Partners with regulatory regional leads for exchange of project/product related information and submission planning.18) Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.19) Monitors and influences changes in the global Regulatorily CMC environment in alignment with business needs.20) Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC LT as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.21) Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.22) Represents Global RegCMC on due diligence and divestment teams as assigned by the Global RegCMC LT.23) Leads or provides input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT.24) Participates in skill development and coaching of other Global RegCMC Team members as required.25) Responsible for management, coaching and development of direct reports as applicable.**KEY CONTACTS & INTERACTIONS:**+ Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.**CUSTOMER FOCUSED:**+ Interacts with key stakeholders both internally and externally, including subject matter experts, partners and regulatory agency personnel.qualifications:**1) Regulatory Skills**- At least 10+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 7+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.- Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.- Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics- Knowledge of global guidance, regulations and ICH/GMP requirements- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure**2) Leadership/Management Skills**- Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.- Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.- Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.- Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.- Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.- Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.- Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.- Competence in people development and management.**PREFEFRED/ADDITIONAL:** Recognized experience in project and people management.**EDUCATION:** BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.skills: CMC, IND, Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
04/15/2021
Full time
Regulatory Affairs Manager III**job details:**+ location:Cambridge, MA+ salary:$71.86 - $84.55 per hour+ date posted:Tuesday, April 13, 2021+ experience:7 Years+ job type:Contract+ industry:Professional, Scientific, and Technical Services+ reference:36020**job description**Regulatory Affairs Manager IIIjob summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!location: Cambridge, Massachusettsjob type: Contractsalary: $71.86 - 84.55 per hourwork hours: 9 to 5education: Bachelorsresponsibilities:The Global Regulatory CMC Early Development Lead, Gene Therapy is responsible for the line management of the team members reporting into him/her, with responsibilities for early stage of development activities for the gene therapy products portfolio. The Global Regulatory CMC Development Lead assigns projects to the team members, supports the team members in setting regulatory CMC strategies and their daily work. He/she ensures coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities. The Global Regulatory CMC Development Lead also acts as Global Reg CMC Lead for assigned programs as needed.This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development gene therapy programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific gene therapy programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program. The role is also responsible to support the evaluation of business development activities including due diligence.The CMC GRL provides regulatory CMC leadership on the cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices and/or supports PDCs.This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required.1) Accountable for line management and development of direct reports.2) Developing soft and technical skills, ensuring coaching and mentoring of the assigned team, and conduct performance assessment.3) Managing team resources efficiently - ensure proper resources allocation, enhance knowledge sharing and support the team to prioritize activities.4) Ensure the development of the Global RegCMC team members by identifying challenging objectives and enhance team visibility as key experts in submissions excellence (including Health Authority interaction and influence).5) Participate in technical and soft skill development, coaching, and performance feedback of the people working in Global RegCMC community, if requested by their management.6) As part of Global RegCMC, participate in the development of working processes and activities to increase the efficiency within Global RegCMC function.7) Accountable for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions.8) Ensures that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.9) Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.10) Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.11) Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.12) Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.13) Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.14) Facilitates capture and communication (within and outside of Global RegCMC) of CMC lessons learned from major submissions for assigned projects/products.15) Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions.16) Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products.17) Partners with regulatory regional leads for exchange of project/product related information and submission planning.18) Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.19) Monitors and influences changes in the global Regulatorily CMC environment in alignment with business needs.20) Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC LT as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.21) Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.22) Represents Global RegCMC on due diligence and divestment teams as assigned by the Global RegCMC LT.23) Leads or provides input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT.24) Participates in skill development and coaching of other Global RegCMC Team members as required.25) Responsible for management, coaching and development of direct reports as applicable.**KEY CONTACTS & INTERACTIONS:**+ Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.**CUSTOMER FOCUSED:**+ Interacts with key stakeholders both internally and externally, including subject matter experts, partners and regulatory agency personnel.qualifications:**1) Regulatory Skills**- At least 10+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 7+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.- Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.- Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics- Knowledge of global guidance, regulations and ICH/GMP requirements- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure**2) Leadership/Management Skills**- Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.- Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.- Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.- Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.- Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.- Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.- Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.- Competence in people development and management.**PREFEFRED/ADDITIONAL:** Recognized experience in project and people management.**EDUCATION:** BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.skills: CMC, IND, Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Company Summary: Founded by Flagship Pioneering, Cellarity is the first company developing medicines through an understanding of cell behaviors. The company's broad platform harnesses single-cell technologies and machine learning to digitize and quantify cellular behaviors, unravel the network dynamics that govern those behaviors, and generate medicines that can direct them. Cellarity is using its platform to design medicines targeting the full cellular and molecular complexity of disease, enabling a quantum leap in the success rate and speed of drug discovery, design and development. For additional information, visit . Position Summary: The Sequencing, Innovation, and Technology group at Cellarity Inc. seeks a Laboratory Automation Engineer to work as the primary engineering resource at a small (50 person) and growing drug discovery startup. The role is focused on laboratory automation and instrumentation, including programming lab automation, as well as designing, building, integrating, maintaining and improving automated methodologies for laboratory biological processes. The work is hands-on, and will require skills in a broad range of engineering disciplines including liquid handling, protocol development, troubleshooting electrical and mechanical systems, and providing operating system validation/verification. The successful candidate will work closely with other researchers in biology, chemistry, technology, sequencing, and machine learning. The candidate must be a creative problem solver, be detail and process oriented, have excellent communication skills, and be eager to work in a dynamic entrepreneurial environment. Key Responsibilities: Manage, plan, develop, and execute laboratory automation projects for molecular biology, genomics, next generation sequencing and cell culture applications from start-up to completion Act as point person for laboratory hardware, QC and preventative maintenance across the organization Implement laboratory instrument software and tools to drive high-throughput processes Optimize and validate protocols to support scale-up Serve as an expert resource to communicate and advise on strategic and tactical issues in automation and engineering Explore, test and as appropriate bring in technology capabilities Requirements: Degree or equivalent professional experience in mechanical or electrical engineering, or biological science related fields. 2+ years' experience in implementation and operation of automated systems, including designing, building and deploying automated laboratory workflows in life sciences or clinical laboratory setting Professional level knowledge of engineering and biological principles, particularly in genomics and DNA sequencing. Expertise in programming Hamilton instrumentation required Familiarity with a wide range of biological laboratory instrumentation 3D printing and fabrication a plus; CAD/Solidworks preferred Proven ability to troubleshoot technical and scientific issues, both individually and as part of a team Recruitment & Staffing Agencies : Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto
04/15/2021
Full time
Company Summary: Founded by Flagship Pioneering, Cellarity is the first company developing medicines through an understanding of cell behaviors. The company's broad platform harnesses single-cell technologies and machine learning to digitize and quantify cellular behaviors, unravel the network dynamics that govern those behaviors, and generate medicines that can direct them. Cellarity is using its platform to design medicines targeting the full cellular and molecular complexity of disease, enabling a quantum leap in the success rate and speed of drug discovery, design and development. For additional information, visit . Position Summary: The Sequencing, Innovation, and Technology group at Cellarity Inc. seeks a Laboratory Automation Engineer to work as the primary engineering resource at a small (50 person) and growing drug discovery startup. The role is focused on laboratory automation and instrumentation, including programming lab automation, as well as designing, building, integrating, maintaining and improving automated methodologies for laboratory biological processes. The work is hands-on, and will require skills in a broad range of engineering disciplines including liquid handling, protocol development, troubleshooting electrical and mechanical systems, and providing operating system validation/verification. The successful candidate will work closely with other researchers in biology, chemistry, technology, sequencing, and machine learning. The candidate must be a creative problem solver, be detail and process oriented, have excellent communication skills, and be eager to work in a dynamic entrepreneurial environment. Key Responsibilities: Manage, plan, develop, and execute laboratory automation projects for molecular biology, genomics, next generation sequencing and cell culture applications from start-up to completion Act as point person for laboratory hardware, QC and preventative maintenance across the organization Implement laboratory instrument software and tools to drive high-throughput processes Optimize and validate protocols to support scale-up Serve as an expert resource to communicate and advise on strategic and tactical issues in automation and engineering Explore, test and as appropriate bring in technology capabilities Requirements: Degree or equivalent professional experience in mechanical or electrical engineering, or biological science related fields. 2+ years' experience in implementation and operation of automated systems, including designing, building and deploying automated laboratory workflows in life sciences or clinical laboratory setting Professional level knowledge of engineering and biological principles, particularly in genomics and DNA sequencing. Expertise in programming Hamilton instrumentation required Familiarity with a wide range of biological laboratory instrumentation 3D printing and fabrication a plus; CAD/Solidworks preferred Proven ability to troubleshoot technical and scientific issues, both individually and as part of a team Recruitment & Staffing Agencies : Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Summary: This role will be the statistical lead for Clinical Serology, a key statistical resource for discovery research and a member of the Data Science Center of Excellence with interfaces across the related Research and Development functions. This cross-functional group has members across Biostatistics, Data Management, Programing and Medical Writing. Integration within this team allows for greater impact across the company. The incumbent will be responsible for ensuring a consistent statistical approach to clinical assay validation that meets regulatory requirements by providing the statistical strategy, guidance and hands on support for clinical assay development and validations at Seqirus and contract testing facilities. In addition, as time permits, the incumbent will provide statistical guidance and support for the development of research assays. Their efforts will drive strategy for successful clinical testing and will be instrumental for the successful growth of the Clinical Serology Group. They will support bridging Research immunological assay development to Clinical Serology validatable assays. They will interact directly with regulatory agencies to represent Seqirus' statistical strategies for assay development and to solve key programmatic issues that would affect licensure. Major Accountabilities: Lead strategic approaches to statistical plans for assays that define key clinical trial success/failure endpoints. Provide technical statistical expertise and guidance for clinical assay validation, including reagent qualification, and testing whether at Seqirus or a contract laboratory. Perform statistical analyses or author/review statistical sections of project reports or key regulatory filings to agencies around the world (FDA, EMEA, TGA, etc.). Provide strategic oversite of clinical serology statistical approaches to ensure consistent approaches are applied across assays, facilities and programs by liaising with internal clinical teams and statisticians as well as external contract clinical testing laboratories. Key aspects involving balancing expectations and needs of internal customers (Clinical, Regulatory, Operations, Research) with the capabilities and methods available at a series of independent, external contract clinical testing laboratories. Efforts will include both work for late stage programs, but also the statistical design and analysis plan required for bridging Research designed assays that are to be used in the Proof-of-concept clinical setting. Lead clinical assay statistical discussions with key internal stakeholders (Clinical, Operations, Regulatory, Research) to assure experimental designs are setup properly and clinical testing strategies will support their relevant endpoints. Similar essential interactions will also be needed for external stakeholders (FDA, EMEA, TGA) where results will support licensure. From time to time, these discussions may include senior leadership (SQLT) to drive programmatic company decisions. Act as the clinical serology statistical resource to provide training and guidance on the application of basic statistical methodology to members of R&D. As the key statistical assay related resource, guidance will be specifically provided for new assays designed in Research intended for use in Proof-of-Concept human clinical trials. Maintain comprehensive knowledge and awareness of developments and trends in statistics and regulatory requirements in relation to the statistical methods applicable to assay development and validation Minimum Requirements: Master's in Statistics and 5+ years experience OR PhD in Statistics with 3+ years in industry providing statistical support; preferably for assay development and validation Requires in-depth conceptual and practical expertise in biostatistics; preferred to have related experience applied to assay development and validation Excellent communication skills both verbally and written; able to explain complex, technical analyses to non-experts In depth GLP understanding and experience Creativity and the ability to generate accurate and reproducible results along with multi-tasking and working effectively in a fast-paced environment are critical. Ability to generate written reports or publications, to prepare and present data at cross-functional meetings and to internal and external stakeholders, and to demonstrate ownership, understanding, and accountability of assigned projects. Demonstration of intellectual and scientific curiosity, a high level of engagement, and initiative to conduct literature review to improve personal understanding and to troubleshoot & advance projects.
04/15/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Summary: This role will be the statistical lead for Clinical Serology, a key statistical resource for discovery research and a member of the Data Science Center of Excellence with interfaces across the related Research and Development functions. This cross-functional group has members across Biostatistics, Data Management, Programing and Medical Writing. Integration within this team allows for greater impact across the company. The incumbent will be responsible for ensuring a consistent statistical approach to clinical assay validation that meets regulatory requirements by providing the statistical strategy, guidance and hands on support for clinical assay development and validations at Seqirus and contract testing facilities. In addition, as time permits, the incumbent will provide statistical guidance and support for the development of research assays. Their efforts will drive strategy for successful clinical testing and will be instrumental for the successful growth of the Clinical Serology Group. They will support bridging Research immunological assay development to Clinical Serology validatable assays. They will interact directly with regulatory agencies to represent Seqirus' statistical strategies for assay development and to solve key programmatic issues that would affect licensure. Major Accountabilities: Lead strategic approaches to statistical plans for assays that define key clinical trial success/failure endpoints. Provide technical statistical expertise and guidance for clinical assay validation, including reagent qualification, and testing whether at Seqirus or a contract laboratory. Perform statistical analyses or author/review statistical sections of project reports or key regulatory filings to agencies around the world (FDA, EMEA, TGA, etc.). Provide strategic oversite of clinical serology statistical approaches to ensure consistent approaches are applied across assays, facilities and programs by liaising with internal clinical teams and statisticians as well as external contract clinical testing laboratories. Key aspects involving balancing expectations and needs of internal customers (Clinical, Regulatory, Operations, Research) with the capabilities and methods available at a series of independent, external contract clinical testing laboratories. Efforts will include both work for late stage programs, but also the statistical design and analysis plan required for bridging Research designed assays that are to be used in the Proof-of-concept clinical setting. Lead clinical assay statistical discussions with key internal stakeholders (Clinical, Operations, Regulatory, Research) to assure experimental designs are setup properly and clinical testing strategies will support their relevant endpoints. Similar essential interactions will also be needed for external stakeholders (FDA, EMEA, TGA) where results will support licensure. From time to time, these discussions may include senior leadership (SQLT) to drive programmatic company decisions. Act as the clinical serology statistical resource to provide training and guidance on the application of basic statistical methodology to members of R&D. As the key statistical assay related resource, guidance will be specifically provided for new assays designed in Research intended for use in Proof-of-Concept human clinical trials. Maintain comprehensive knowledge and awareness of developments and trends in statistics and regulatory requirements in relation to the statistical methods applicable to assay development and validation Minimum Requirements: Master's in Statistics and 5+ years experience OR PhD in Statistics with 3+ years in industry providing statistical support; preferably for assay development and validation Requires in-depth conceptual and practical expertise in biostatistics; preferred to have related experience applied to assay development and validation Excellent communication skills both verbally and written; able to explain complex, technical analyses to non-experts In depth GLP understanding and experience Creativity and the ability to generate accurate and reproducible results along with multi-tasking and working effectively in a fast-paced environment are critical. Ability to generate written reports or publications, to prepare and present data at cross-functional meetings and to internal and external stakeholders, and to demonstrate ownership, understanding, and accountability of assigned projects. Demonstration of intellectual and scientific curiosity, a high level of engagement, and initiative to conduct literature review to improve personal understanding and to troubleshoot & advance projects.
Amgen is the world's leading biotechnology company. Nurtured on a foundation of strong values, Amgen is deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Our mission is to serve patients, and we encompass this with each initiative, goal and task we have in mind! It guides us as we continue to research, manufacture and deliver new medicines and reach millions of patients. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. At Amgen, there is a strong correlation between our high level of diversity and performance. We use our global talent to achieve together-to transform the promise of science and biotechnology into therapies that have the power to restore health. Amgen: We live the mission. We win together. We thrive on continual challenge We are seeking a 6-month co-op from July to Decemfor the Cambridge, MA Pilot Plant to help onboard automated manufacturing equipment to support next-gen manufacturing paradigms. The Co-op project will focus on mapping automated processes and functional troubleshooting. Training in distributed control systems (DCSs), Process and Instrumentation Diagrams (P&ID), and other process documents will be provided as needed. Additional responsibilities include cross-training in process and operations engineering functions in the pilot lab. The position is expected to be performed remotely. Basic Qualifications Amgen requires that all individuals applying for an undergraduate internship or an undergraduate co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Preferred Qualifications Degree concentration(s) in chemical engineering, bioengineering, electrical engineering or related field Coursework in process controls engineering At least one programming language Graduation by summer 2022 Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Only candidates who apply via will be considered. Please search for Keyword 112649 #LI-DNP Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
04/15/2021
Full time
Amgen is the world's leading biotechnology company. Nurtured on a foundation of strong values, Amgen is deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Our mission is to serve patients, and we encompass this with each initiative, goal and task we have in mind! It guides us as we continue to research, manufacture and deliver new medicines and reach millions of patients. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. At Amgen, there is a strong correlation between our high level of diversity and performance. We use our global talent to achieve together-to transform the promise of science and biotechnology into therapies that have the power to restore health. Amgen: We live the mission. We win together. We thrive on continual challenge We are seeking a 6-month co-op from July to Decemfor the Cambridge, MA Pilot Plant to help onboard automated manufacturing equipment to support next-gen manufacturing paradigms. The Co-op project will focus on mapping automated processes and functional troubleshooting. Training in distributed control systems (DCSs), Process and Instrumentation Diagrams (P&ID), and other process documents will be provided as needed. Additional responsibilities include cross-training in process and operations engineering functions in the pilot lab. The position is expected to be performed remotely. Basic Qualifications Amgen requires that all individuals applying for an undergraduate internship or an undergraduate co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Preferred Qualifications Degree concentration(s) in chemical engineering, bioengineering, electrical engineering or related field Coursework in process controls engineering At least one programming language Graduation by summer 2022 Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Only candidates who apply via will be considered. Please search for Keyword 112649 #LI-DNP Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Director Sales Operations & OVAS Company: Ipsen Biopharmaceuticals Inc. Job Description: Job Title: Director, Oncology Sales Operations & OVAS Division / Function: Oncology Manager (Name, Job Title): David Cummins, Vice President Oncology Sales Location: Cambridge Summary The Director, Oncology Sales Operations & OVAS will serve as the Business Operations Lead for the Oncology sales organization. This role serves as a key point of contact and subject matter expert for Sales Leadership and the Oncology Field Salesforce. This position will also lead a team of account specialists with a high focus on executing effective virtual customer engagements. This position is responsible for the field planning process for Somatuline Depot, Onivyde and future launch products. The Director, Oncology Sales Operations & OVAS is also responsible for aligning field and home office management and communications. This role will ensure sizing recommendations are consistent with current workload assumptions. This role is also responsible for ensuring that the strategy and field execution is effective and compliant. This position will have significant interaction with sales leadership, Marketing leadership and all key internal stakeholders impacting the Oncology sales Team. Main Responsibilities Operational accountabilities Support VP Oncology sales Create executive presentations Develop and QC key sales presentations and deliverables. Staff, business review process execution Lead coordination and development of POA meetings- Semester Planning Process & Execution Lead coordination of key oncology meetings and events. Collaborate with brand teams and operations team to manage and deploy marketing materials utilized the by field, accountable for the CRM system and other field deployed technologies. Sales data and analytics, performance reports and budget management Support business and process related inquiries Provide Nation, Region, Territory and business analytics. Work with internal team to manage and execute incentive compensation plans for the sales force Refine/ develop brand dashboards, reporting, analytics Review size, structure and performance of field team- participate in targeting and size and structure meetings Manage all Oncology-specific field communications. Drive development of strategic resources to meet Business Unit goals. Deliver on Call Planning & Alignment Operations of Account Planning. Support business and process related inquiries. Liaison with brand leads on strategic imperative execution & planning future launch products/ indications. Leadership accountabilities Drive execution of customer field facing activities including continuous learning plan Co-Lead Virtual Customer Engagement (OVAS) team to represent Ipsen's Oncology product in the U.S. marketplace. Collaborate with RBDs to provide support with sales force execution and business needs Collaborate with Director of CNE team to review execution and resource support Lead development projects for the field. Assess training needs and collaborate with internal and external providers on the creation of new resources. Cross functional team lead-stakeholder management. Participate in cross functional meetings to provide Oncology specific system requirements. Collaborate with RBDs to provide analytics and support -review Call Plan and Field Execution, make recommendations as appropriate. Collaborate with HR to manage development and year end performance review cycle requirements. Build/coach to highly effective virtual selling competencies. Assess effective use of available technology platforms, marketing assets, and multi-channel communications to engage with customers virtually Ensure field adherence to compliance/legal regulations. Complies with all laws regulations and policies that govern the conduct of Ipsen U.S. staff. Knowledge, Abilities & Experience Education / Certifications: Bachelor's degree from accredited college or university; Masters a plus Experience: Minimum 10 years of experience in progressively responsible roles in Business Operations/Analytics in Pharmaceutical/Biotech industry. Minimum 3 years demonstrated success in the Oncology marketplace. Minimum 3 years of experience in the planning and management of Sales meetings such as quarterly POAs and annual meetings. Minimum 3 years of experience of direct team leadership/management. Expertise in computer technology and all related digital platforms specific to virtual engagement. Launch experience (Oncology preferred). Demonstrated strong capability in account management, superior selling competencies and proven sales performance track record of meeting or exceeding goals. Demonstrated strong business analytics to understand and analyze business and market drivers, and develop, execute and adjust customer business plans. Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network. Work effectively in a matrix environment maintaining collaborative relationships with all internal and external stakeholders. Proven ability to manage multiple tasks, set priorities and meet deadlines. Key Technical Competencies Required Demonstrated knowledge of Sales Analytics including but not limited to: Territory analysis; business planning, staffing planning Proven ability to work collaboratively and in a leadership role across functions including: Marketing; Medical Affairs; Clinical Education; Human Resources; Regulatory/Compliance. Excellent written and verbal English communication skills; excellent presentation skills to groups of diverse size and make up. Proven ability to work well with leadership team, and the ability to lead and influence across multiple levels and functions of the organization without direct authority. Demonstrated strong knowledge of biopharma government and compliance regulations enabling individual to work with limited risk within an environment of strict compliance and appropriate regulatory guidelines to successfully design and execute tactics, programs and tools that achieve business objectives. Demonstrated commitment to working within compliance and regulatory mandates. Demonstrated proficiency in use of sales analytics software, experience with VEEVA preferred. Willingness and ability to travel by private and public transportation up to 20%. Demonstrated ability to effectively communicate with customers, internal and external contacts at all levels Experienced with current video tools like Teams, Zoom, Webex, etc. Learning agility to quickly adapt and being proficient on new tools and technology Presenting visual materials in a comprehensive and efficient way Strong proficiency with virtual tools to enable the customer experience such as Calendly or other scheduling tools (easier for client to book meeting, provides automatic reminders, etc. and logistical aspects like setting up a call or signing a contract with tools like Docusign or Pandadoc.) IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
04/14/2021
Full time
Title: Director Sales Operations & OVAS Company: Ipsen Biopharmaceuticals Inc. Job Description: Job Title: Director, Oncology Sales Operations & OVAS Division / Function: Oncology Manager (Name, Job Title): David Cummins, Vice President Oncology Sales Location: Cambridge Summary The Director, Oncology Sales Operations & OVAS will serve as the Business Operations Lead for the Oncology sales organization. This role serves as a key point of contact and subject matter expert for Sales Leadership and the Oncology Field Salesforce. This position will also lead a team of account specialists with a high focus on executing effective virtual customer engagements. This position is responsible for the field planning process for Somatuline Depot, Onivyde and future launch products. The Director, Oncology Sales Operations & OVAS is also responsible for aligning field and home office management and communications. This role will ensure sizing recommendations are consistent with current workload assumptions. This role is also responsible for ensuring that the strategy and field execution is effective and compliant. This position will have significant interaction with sales leadership, Marketing leadership and all key internal stakeholders impacting the Oncology sales Team. Main Responsibilities Operational accountabilities Support VP Oncology sales Create executive presentations Develop and QC key sales presentations and deliverables. Staff, business review process execution Lead coordination and development of POA meetings- Semester Planning Process & Execution Lead coordination of key oncology meetings and events. Collaborate with brand teams and operations team to manage and deploy marketing materials utilized the by field, accountable for the CRM system and other field deployed technologies. Sales data and analytics, performance reports and budget management Support business and process related inquiries Provide Nation, Region, Territory and business analytics. Work with internal team to manage and execute incentive compensation plans for the sales force Refine/ develop brand dashboards, reporting, analytics Review size, structure and performance of field team- participate in targeting and size and structure meetings Manage all Oncology-specific field communications. Drive development of strategic resources to meet Business Unit goals. Deliver on Call Planning & Alignment Operations of Account Planning. Support business and process related inquiries. Liaison with brand leads on strategic imperative execution & planning future launch products/ indications. Leadership accountabilities Drive execution of customer field facing activities including continuous learning plan Co-Lead Virtual Customer Engagement (OVAS) team to represent Ipsen's Oncology product in the U.S. marketplace. Collaborate with RBDs to provide support with sales force execution and business needs Collaborate with Director of CNE team to review execution and resource support Lead development projects for the field. Assess training needs and collaborate with internal and external providers on the creation of new resources. Cross functional team lead-stakeholder management. Participate in cross functional meetings to provide Oncology specific system requirements. Collaborate with RBDs to provide analytics and support -review Call Plan and Field Execution, make recommendations as appropriate. Collaborate with HR to manage development and year end performance review cycle requirements. Build/coach to highly effective virtual selling competencies. Assess effective use of available technology platforms, marketing assets, and multi-channel communications to engage with customers virtually Ensure field adherence to compliance/legal regulations. Complies with all laws regulations and policies that govern the conduct of Ipsen U.S. staff. Knowledge, Abilities & Experience Education / Certifications: Bachelor's degree from accredited college or university; Masters a plus Experience: Minimum 10 years of experience in progressively responsible roles in Business Operations/Analytics in Pharmaceutical/Biotech industry. Minimum 3 years demonstrated success in the Oncology marketplace. Minimum 3 years of experience in the planning and management of Sales meetings such as quarterly POAs and annual meetings. Minimum 3 years of experience of direct team leadership/management. Expertise in computer technology and all related digital platforms specific to virtual engagement. Launch experience (Oncology preferred). Demonstrated strong capability in account management, superior selling competencies and proven sales performance track record of meeting or exceeding goals. Demonstrated strong business analytics to understand and analyze business and market drivers, and develop, execute and adjust customer business plans. Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network. Work effectively in a matrix environment maintaining collaborative relationships with all internal and external stakeholders. Proven ability to manage multiple tasks, set priorities and meet deadlines. Key Technical Competencies Required Demonstrated knowledge of Sales Analytics including but not limited to: Territory analysis; business planning, staffing planning Proven ability to work collaboratively and in a leadership role across functions including: Marketing; Medical Affairs; Clinical Education; Human Resources; Regulatory/Compliance. Excellent written and verbal English communication skills; excellent presentation skills to groups of diverse size and make up. Proven ability to work well with leadership team, and the ability to lead and influence across multiple levels and functions of the organization without direct authority. Demonstrated strong knowledge of biopharma government and compliance regulations enabling individual to work with limited risk within an environment of strict compliance and appropriate regulatory guidelines to successfully design and execute tactics, programs and tools that achieve business objectives. Demonstrated commitment to working within compliance and regulatory mandates. Demonstrated proficiency in use of sales analytics software, experience with VEEVA preferred. Willingness and ability to travel by private and public transportation up to 20%. Demonstrated ability to effectively communicate with customers, internal and external contacts at all levels Experienced with current video tools like Teams, Zoom, Webex, etc. Learning agility to quickly adapt and being proficient on new tools and technology Presenting visual materials in a comprehensive and efficient way Strong proficiency with virtual tools to enable the customer experience such as Calendly or other scheduling tools (easier for client to book meeting, provides automatic reminders, etc. and logistical aspects like setting up a call or signing a contract with tools like Docusign or Pandadoc.) IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
What's in it for you? TheDirector, Global Tax and Treasuryis a highly-visible role that will be responsible for the managing the Company's global tax and treasury functions (approximately 75% and 25%, respectively). In this role you will manage all tax accounting, compliance, and filing requirements for our organization, as well play a critical role in developing and implementing the Company's evolving global tax strategy. This role will also oversee the Company's treasury function and be responsible for managing relationships with banking and treasury service providers, monitoring cash flow needs, and executing our investment strategy. Reporting to the VP Corporate Controller, the Director, Global Tax and Treasury must have a proven track record of effectively interpreting and applying tax guidance, ensuring tax compliance, as well as the ability to effectively manage treasury operations. This individual must be an effective multi-tasker with the ability to prioritize and execute key initiatives, with strong attention to detail and a dedication to quality. This position is a key financial strategic partner and plays a critical role in supporting the growth of the business. If you are looking for highly visible leadership role where you can develop a tax function for a rapidly growing organization, then this role could be a great fit for you! What will you be doing?. Tax Function (approximately 75% of role): Ensure Federal, foreign, state, and local income tax compliance, as well as compliance with franchise, property and other non-income taxes. Drive accounting for income taxes for the Company on a quarterly and annual basis, including review of the quarterly and annual tax provision, as well as ensure proper financial statement presentation and disclosure. Coordinate and review of the outsourced US Federal and state income tax filings, including extensions. Coordinate and review of the outsourced International tax filings and approve returns and tax payments, including VAT. Provide strategic insight as the Company expands its operational footprint, both domestically and internationally, by recommending and executing federal, state, and international income tax strategies. Remain current with legislative tax changes and tax-related accounting pronouncements. Perform research on various tax issues including US federal, state, and international tax. Analyze tax information and consider tax strategies related to potential business development opportunities. Review Company's Transfer Pricing position and ensure ongoing compliance. Complete various analyses throughout the year to assist with the annual budgeting and forecasting process. Partner with external tax advisors in the US and in international jurisdictions. Develop and maintain relationships throughout the finance organization and cross-functionally to increase understanding of the business and potential impacts on tax compliance and strategy. Prepare ad hoc analyses, and lead or assist with special projects as needed. Ensure adherence to SOX business controls to eliminate risks for the Company. Treasury Function (approximately 25% of role): Management of liquidity and cash assets, as well as overseeing work of accounting team. Manage and maintain relationships with banking and treasury service providers. Ensure adequate cash funding in accounts to meet daily liquidity needs. Analyze, recommend, monitor, and manage investment strategy. Review investment opportunities and present opportunities in line with Investment Policy to senior leadership team. Maintain weekly, monthly, and long-term Treasury cash forecasts. Review FX exposure and implement programs to reduce volatility as needed. Review, recommend, design and implement operational improvements. Ensure adherence to SOX business controls to eliminate risks for the Company. What are we looking for?: 10+ years of progressive experience in tax role, with CPA or MST required. Prior experience working for a public accounting firm required; experience managing the tax function in a publicly traded company (biotech), strongly preferred. Strong knowledge of US GAAP, including ASC 740 accounting for income taxes, as well as SOX: Strong interpersonal, verbal, and written communication skills. Ability to work cross-functionally and manage competing priorities with deadlines, without sacrificing quality: Ability to work independently as well as work effectively with external tax service providers and consultants to execute on strategic initiatives. Proven ability to work in the details, as well as communicate and manage well at all levels of the company. A high level of analytical and strategic ability is required. Embrace our core values: Team collaboration, Accelerating drug discovery, Commitment to patients, Employee development. How will you grow with us? Our active pipeline and fast pace provides an exciting opportunity to join a dynamic team and take on a hands-on role where you will be able to significantly contribute to the strategy and initiatives within the Finance group.With the recent approval of Reblozyl, the recent announcement of PULSAR Phase 2 results, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history.This opportunity will allow you to develop your skills by taking on new challenges and partnering with dedicated team members who will motivate and support you. Join our team and apply today! *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
04/14/2021
Full time
What's in it for you? TheDirector, Global Tax and Treasuryis a highly-visible role that will be responsible for the managing the Company's global tax and treasury functions (approximately 75% and 25%, respectively). In this role you will manage all tax accounting, compliance, and filing requirements for our organization, as well play a critical role in developing and implementing the Company's evolving global tax strategy. This role will also oversee the Company's treasury function and be responsible for managing relationships with banking and treasury service providers, monitoring cash flow needs, and executing our investment strategy. Reporting to the VP Corporate Controller, the Director, Global Tax and Treasury must have a proven track record of effectively interpreting and applying tax guidance, ensuring tax compliance, as well as the ability to effectively manage treasury operations. This individual must be an effective multi-tasker with the ability to prioritize and execute key initiatives, with strong attention to detail and a dedication to quality. This position is a key financial strategic partner and plays a critical role in supporting the growth of the business. If you are looking for highly visible leadership role where you can develop a tax function for a rapidly growing organization, then this role could be a great fit for you! What will you be doing?. Tax Function (approximately 75% of role): Ensure Federal, foreign, state, and local income tax compliance, as well as compliance with franchise, property and other non-income taxes. Drive accounting for income taxes for the Company on a quarterly and annual basis, including review of the quarterly and annual tax provision, as well as ensure proper financial statement presentation and disclosure. Coordinate and review of the outsourced US Federal and state income tax filings, including extensions. Coordinate and review of the outsourced International tax filings and approve returns and tax payments, including VAT. Provide strategic insight as the Company expands its operational footprint, both domestically and internationally, by recommending and executing federal, state, and international income tax strategies. Remain current with legislative tax changes and tax-related accounting pronouncements. Perform research on various tax issues including US federal, state, and international tax. Analyze tax information and consider tax strategies related to potential business development opportunities. Review Company's Transfer Pricing position and ensure ongoing compliance. Complete various analyses throughout the year to assist with the annual budgeting and forecasting process. Partner with external tax advisors in the US and in international jurisdictions. Develop and maintain relationships throughout the finance organization and cross-functionally to increase understanding of the business and potential impacts on tax compliance and strategy. Prepare ad hoc analyses, and lead or assist with special projects as needed. Ensure adherence to SOX business controls to eliminate risks for the Company. Treasury Function (approximately 25% of role): Management of liquidity and cash assets, as well as overseeing work of accounting team. Manage and maintain relationships with banking and treasury service providers. Ensure adequate cash funding in accounts to meet daily liquidity needs. Analyze, recommend, monitor, and manage investment strategy. Review investment opportunities and present opportunities in line with Investment Policy to senior leadership team. Maintain weekly, monthly, and long-term Treasury cash forecasts. Review FX exposure and implement programs to reduce volatility as needed. Review, recommend, design and implement operational improvements. Ensure adherence to SOX business controls to eliminate risks for the Company. What are we looking for?: 10+ years of progressive experience in tax role, with CPA or MST required. Prior experience working for a public accounting firm required; experience managing the tax function in a publicly traded company (biotech), strongly preferred. Strong knowledge of US GAAP, including ASC 740 accounting for income taxes, as well as SOX: Strong interpersonal, verbal, and written communication skills. Ability to work cross-functionally and manage competing priorities with deadlines, without sacrificing quality: Ability to work independently as well as work effectively with external tax service providers and consultants to execute on strategic initiatives. Proven ability to work in the details, as well as communicate and manage well at all levels of the company. A high level of analytical and strategic ability is required. Embrace our core values: Team collaboration, Accelerating drug discovery, Commitment to patients, Employee development. How will you grow with us? Our active pipeline and fast pace provides an exciting opportunity to join a dynamic team and take on a hands-on role where you will be able to significantly contribute to the strategy and initiatives within the Finance group.With the recent approval of Reblozyl, the recent announcement of PULSAR Phase 2 results, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history.This opportunity will allow you to develop your skills by taking on new challenges and partnering with dedicated team members who will motivate and support you. Join our team and apply today! *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. How You Will Achieve More With Intellia: We are seeking an experienced biopharmaceutical attorney to join and contribute toward making a big impact with our legal team as we develop human therapeutics using CRISPR/Cas9 technology. The ideal candidate has a strong background in the biotechnology industry supporting and providing advice on a broad range of strategic matters for the Company's regulatory, compliance, commercial, and privacy, and other corporate legal issues. Most importantly, the ideal candidate can live up to our Values of One, Explore, Disrupt and Deliver by being able to work with multiple cross-functional teams to look for innovative solutions to positively change the lives of patients with severe and life-threatening diseases. Responsibilities: Provide high quality, timely and practical legal advice, and guidance, identify, and help resolve critical legal and business issues arising from regulatory, pre-clinical, clinical, technical operations, and research and development activities. Advise on regulatory requirements regarding investigational product submissions, clinical trials, drug safety management, and commercialization in the United States, Europe, and other key jurisdictions. Provide practical legal advice relating to applicable laws and regulations, as well as contractual obligations, while proactively identifying and helping manage risk profile of the company. Represent Intellia in interactions with FDA, EMA and other global agencies that may affect the company's development and commercialization plans. Act as the legal internal stakeholder for cross-functional teams, such as development program teams or medical and legal review teams. Work with the contracts team, as necessary, in drafting and negotiating contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements. Review and approve presentations, press releases, website materials, brochures, and other company communications (internal and external). Manage relationship with outside law firms. Counsel advise and train internal (and external) teams to ensure compliance with applicable laws and regulations and company policies and procedures. Qualifications: Licensed attorney with 14+ years of experience in the biotechnology/pharmaceutical industry, and at least 6 years in a biopharmaceutical company providing advice on clinical and commercial experience matters. Excellent knowledge and experience advising clients on laws and regulations governing the biotechnology industry both in and outside the U.S., including FDA and EMA requirements, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, GDPR and other privacy laws, and product liability laws. Demonstrated leadership qualities including experience managing cross-functional legal teams, as well as sound business and legal judgment, and strategic and analytical thinking. Real-time risk management capabilities in a landscape with shifting regulations and guidance and capability to provide long-term vision for the company. Self-motivated, practical, and interested in working on a wide range of legal matters to lead the Company on legal implications of its business strategy. Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to executive leadership and senior management. Excellent organizational skills and able to work with a team to meet critical deadlines; flexible and capable of managing multiple projects simultaneously. #LI-DG1 EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
04/14/2021
Full time
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. How You Will Achieve More With Intellia: We are seeking an experienced biopharmaceutical attorney to join and contribute toward making a big impact with our legal team as we develop human therapeutics using CRISPR/Cas9 technology. The ideal candidate has a strong background in the biotechnology industry supporting and providing advice on a broad range of strategic matters for the Company's regulatory, compliance, commercial, and privacy, and other corporate legal issues. Most importantly, the ideal candidate can live up to our Values of One, Explore, Disrupt and Deliver by being able to work with multiple cross-functional teams to look for innovative solutions to positively change the lives of patients with severe and life-threatening diseases. Responsibilities: Provide high quality, timely and practical legal advice, and guidance, identify, and help resolve critical legal and business issues arising from regulatory, pre-clinical, clinical, technical operations, and research and development activities. Advise on regulatory requirements regarding investigational product submissions, clinical trials, drug safety management, and commercialization in the United States, Europe, and other key jurisdictions. Provide practical legal advice relating to applicable laws and regulations, as well as contractual obligations, while proactively identifying and helping manage risk profile of the company. Represent Intellia in interactions with FDA, EMA and other global agencies that may affect the company's development and commercialization plans. Act as the legal internal stakeholder for cross-functional teams, such as development program teams or medical and legal review teams. Work with the contracts team, as necessary, in drafting and negotiating contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements. Review and approve presentations, press releases, website materials, brochures, and other company communications (internal and external). Manage relationship with outside law firms. Counsel advise and train internal (and external) teams to ensure compliance with applicable laws and regulations and company policies and procedures. Qualifications: Licensed attorney with 14+ years of experience in the biotechnology/pharmaceutical industry, and at least 6 years in a biopharmaceutical company providing advice on clinical and commercial experience matters. Excellent knowledge and experience advising clients on laws and regulations governing the biotechnology industry both in and outside the U.S., including FDA and EMA requirements, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, GDPR and other privacy laws, and product liability laws. Demonstrated leadership qualities including experience managing cross-functional legal teams, as well as sound business and legal judgment, and strategic and analytical thinking. Real-time risk management capabilities in a landscape with shifting regulations and guidance and capability to provide long-term vision for the company. Self-motivated, practical, and interested in working on a wide range of legal matters to lead the Company on legal implications of its business strategy. Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to executive leadership and senior management. Excellent organizational skills and able to work with a team to meet critical deadlines; flexible and capable of managing multiple projects simultaneously. #LI-DG1 EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute that vision. The Protein Engineering Senior Research Associate will be responsible for the testing of proteins and DNA vectors that support our novel targeted gene therapy platform. Characterization of therapeutic candidates, alongside in vitro assay development will be key elements of the position. This individual will join a dynamic, rapidly growing, and highly collaborative team that combines significant biologic drug discovery experience with pioneering discoveries driving multiple biological platforms. DUTIES AND RESPONSIBILITIES Testing of novel constructs for mammalian cell transduction via flow cytometry and imaging techniques Assay development for testing novel protein vectors that support our platform technology Characterization of gene expression and cell-identity markers in mammalian cells using flow cytometry, microscopy, qPCR, ELISA, etc. Mammalian cell culture and transformation Following Standard Operating Procedures and developing new protocols when necessary Working collaboratively to generate and screen novel therapeutics Maintenance of detailed electronic lab notebook and registration of constructs and biologics QUALIFICATIONS Basic Qualifications Bachelors Degree plus 3+ years laboratory experience in an academic or industry setting, or Masters Degree in related field (Biology, Biochemistry, Engineering) with at least 1+ years with laboratory experience in an academic or industry setting. Well versed in a wide array of laboratory techniques and experienced in their use. Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with collaborators. Attention to detail and data quality, and experience working on collaborative teams. Preferred Qualifications Demonstrated ability in working in a fast-paced, collaborative, and technical environment. Excellent bench skills with attention to detail for data integrity and quality. Understanding of mammalian molecular biology and cell biology. Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. PHYSICAL REQUIREMENTS Carrying, handling and reaching for objects up to 25 lbs Prolonged standing and/or sitting Exposure to hazardous/toxic/dangerous chemicals Manual dexterity required to operate office and lab equipment
04/14/2021
Full time
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute that vision. The Protein Engineering Senior Research Associate will be responsible for the testing of proteins and DNA vectors that support our novel targeted gene therapy platform. Characterization of therapeutic candidates, alongside in vitro assay development will be key elements of the position. This individual will join a dynamic, rapidly growing, and highly collaborative team that combines significant biologic drug discovery experience with pioneering discoveries driving multiple biological platforms. DUTIES AND RESPONSIBILITIES Testing of novel constructs for mammalian cell transduction via flow cytometry and imaging techniques Assay development for testing novel protein vectors that support our platform technology Characterization of gene expression and cell-identity markers in mammalian cells using flow cytometry, microscopy, qPCR, ELISA, etc. Mammalian cell culture and transformation Following Standard Operating Procedures and developing new protocols when necessary Working collaboratively to generate and screen novel therapeutics Maintenance of detailed electronic lab notebook and registration of constructs and biologics QUALIFICATIONS Basic Qualifications Bachelors Degree plus 3+ years laboratory experience in an academic or industry setting, or Masters Degree in related field (Biology, Biochemistry, Engineering) with at least 1+ years with laboratory experience in an academic or industry setting. Well versed in a wide array of laboratory techniques and experienced in their use. Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with collaborators. Attention to detail and data quality, and experience working on collaborative teams. Preferred Qualifications Demonstrated ability in working in a fast-paced, collaborative, and technical environment. Excellent bench skills with attention to detail for data integrity and quality. Understanding of mammalian molecular biology and cell biology. Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. PHYSICAL REQUIREMENTS Carrying, handling and reaching for objects up to 25 lbs Prolonged standing and/or sitting Exposure to hazardous/toxic/dangerous chemicals Manual dexterity required to operate office and lab equipment
What's in it for you?. The Sr. Director, US Payer Marketing is a critical role within the commercial organization, responsible for serving as strategic partner and to assist in the development and execution of Market Access strategies and tactics to maximize patient access to therapy, developing and implementing payer marketing strategies to secure, maintain and drive optimal access for the product portfolio. Reporting to the VP, North America Market Access, he/she works closely with a cross-functional group including Market Access Corporate Accounts, Patient Services & Reimbursement, Brand Marketing and Sales, Trade, Compliance, Legal, Business Analytics and external vendors among others to develop impactful strategies and tactics for patient services and reimbursement. The position requires strong knowledge of the payer, distribution and patient services space and must be a strategic thinker and the ability to drive cross-functional change both internally and externally. What will you be doing?: Serve as key member of Managed Markets leadership with continuous input into team goals, objectives and strategies. Drives the development of Managed Markets over-arching business plan and product launch plans. Collaborates with cross-functional partners (Brand Marketing, HEOR, Account Directors, Medical Affairs and other key internal stakeholders) to develop comprehensive channel strategies and tactics that align to the marketing objectives. In partnership with Global HEOR, lead development of a compelling Managed Markets brand value propositions that communicate the clinical, economic and value-based attributes of Acceleron brands. Responsible for the development and implementation of the Market Access strategic plan to meet customer and patient needs. Development of strategy, programs and collateral to support education of physicians/hospitals/practices/patients on matters related to reimbursement and market access. Oversee development of materials aimed at sales team education. Partners with therapeutic area marketing lead to develop and execute access strategies. Partners with Patient Services and Distribution to enhance patient access, drive process improvements and ensures effective execution within legal and compliance requirements. This individual will monitor the changing payer landscape mergers and acquisitions (industry consolidation), benefit design trends, strategic account trends, medical loss ratios, quality metrics, and the evolution of the Affordable Care Act. Identify opportunities for improvement, and develop unique solutions to provide improved patient access. Serve as a content expert for all areas related to patient services and reimbursement to champion related materials through the PRC approval process. Partner with Legal and Compliance to ensure that all programs are consistent with the latest laws, guidance, and corporate policies. Provide proactive market feedback to Market Access and cross functional teams on business trends, competitive updates, industry issues and opportunities. What are we looking for?: Bachelor's degree. MBA or advanced degree desired but not required. 15 years' experience in pharmaceutical, biotech or related industry. Prefer minimum of 6 years of experience in the following areas: Managed Care Channel Marketing, Payer Marketing, Brand Marketing, or Account Management: Launch experience with specialty brands. Results oriented with excellent analytic, collaboration, communication and presentation skills. Extensive knowledge and experience across managed markets, brand marketing and sales management in the pharmaceutical, biotech, or related industry. Experience with building and executing brand/payer business plans. Extensive knowledge and experience across pharmaceutical product life-cycle. Proven ability of successfully managing complexity, solving problems, and building strong relationships. Strong written and oral communication skills. Comprehensive understanding of US healthcare system including providers, payers (public and private) and influencers. Analytic skills including experience in conducting research, data mining, modeling, or contract analysis. Ability to lead cross-functional teams. An entrepreneurial spirit and ability to identify problems and barriers and quickly assimilate information to develop actionable and effective solutions. Ability to manage ambiguity in a highly matrixed environment. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
04/14/2021
Full time
What's in it for you?. The Sr. Director, US Payer Marketing is a critical role within the commercial organization, responsible for serving as strategic partner and to assist in the development and execution of Market Access strategies and tactics to maximize patient access to therapy, developing and implementing payer marketing strategies to secure, maintain and drive optimal access for the product portfolio. Reporting to the VP, North America Market Access, he/she works closely with a cross-functional group including Market Access Corporate Accounts, Patient Services & Reimbursement, Brand Marketing and Sales, Trade, Compliance, Legal, Business Analytics and external vendors among others to develop impactful strategies and tactics for patient services and reimbursement. The position requires strong knowledge of the payer, distribution and patient services space and must be a strategic thinker and the ability to drive cross-functional change both internally and externally. What will you be doing?: Serve as key member of Managed Markets leadership with continuous input into team goals, objectives and strategies. Drives the development of Managed Markets over-arching business plan and product launch plans. Collaborates with cross-functional partners (Brand Marketing, HEOR, Account Directors, Medical Affairs and other key internal stakeholders) to develop comprehensive channel strategies and tactics that align to the marketing objectives. In partnership with Global HEOR, lead development of a compelling Managed Markets brand value propositions that communicate the clinical, economic and value-based attributes of Acceleron brands. Responsible for the development and implementation of the Market Access strategic plan to meet customer and patient needs. Development of strategy, programs and collateral to support education of physicians/hospitals/practices/patients on matters related to reimbursement and market access. Oversee development of materials aimed at sales team education. Partners with therapeutic area marketing lead to develop and execute access strategies. Partners with Patient Services and Distribution to enhance patient access, drive process improvements and ensures effective execution within legal and compliance requirements. This individual will monitor the changing payer landscape mergers and acquisitions (industry consolidation), benefit design trends, strategic account trends, medical loss ratios, quality metrics, and the evolution of the Affordable Care Act. Identify opportunities for improvement, and develop unique solutions to provide improved patient access. Serve as a content expert for all areas related to patient services and reimbursement to champion related materials through the PRC approval process. Partner with Legal and Compliance to ensure that all programs are consistent with the latest laws, guidance, and corporate policies. Provide proactive market feedback to Market Access and cross functional teams on business trends, competitive updates, industry issues and opportunities. What are we looking for?: Bachelor's degree. MBA or advanced degree desired but not required. 15 years' experience in pharmaceutical, biotech or related industry. Prefer minimum of 6 years of experience in the following areas: Managed Care Channel Marketing, Payer Marketing, Brand Marketing, or Account Management: Launch experience with specialty brands. Results oriented with excellent analytic, collaboration, communication and presentation skills. Extensive knowledge and experience across managed markets, brand marketing and sales management in the pharmaceutical, biotech, or related industry. Experience with building and executing brand/payer business plans. Extensive knowledge and experience across pharmaceutical product life-cycle. Proven ability of successfully managing complexity, solving problems, and building strong relationships. Strong written and oral communication skills. Comprehensive understanding of US healthcare system including providers, payers (public and private) and influencers. Analytic skills including experience in conducting research, data mining, modeling, or contract analysis. Ability to lead cross-functional teams. An entrepreneurial spirit and ability to identify problems and barriers and quickly assimilate information to develop actionable and effective solutions. Ability to manage ambiguity in a highly matrixed environment. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
What's in it for you?. The Medical Director, Pulmonary, reporting to the VP, Global Medical Affairs Strategy, will be responsible for providing strategic and scientific leadership for the pulmonary program, including sotatercept, the lead product in late-stage development. The successful candidate will lead the Medical Affairs sub-team to develop global medical strategy for sotatercept, in alignment with pulmonary program strategy. This individual will be accountable for strategic oversight of all medical affairs activities across regions. The successful candidate will serve as the primary point of contact for country medical teams and liaising with counterparts in R&D and Commercial. What will you be doing?: Represent Medical Affairs at the sotatercept program team and global brand team, serving as a strong strategic partner to internal stakeholders. Provide strategic and scientific leadership for the sotatercept program by leading the Medical Affairs sub-team to develop global medical strategy, in alignment with pulmonary program strategy; accountable for effective execution of global medical tactics. Provide strategic oversight for medical affairs activities across regions by partnering with Medical Planning & Operations to track key milestones. Partner with Real-World Evidence team and other stakeholders to develop evidence generation strategy; provide medical oversight for Medical Affairs led studies, including post-hoc analyses of pivotal studies, phase 4 studies, registries; review & approve IIS & local regional study proposals. Provide Medical Affairs input to pivotal study design, ensuring study design address key stakeholder needs. Partner with Medical Communication to ensure timely dissemination of scientific data (e.g. publication and medical congress); review and sign off on abstracts, posters, and publications. Provide medical oversight for key Medical Affairs content such as FAQs. Accountable for authoring EAP protocol, medical review and approval of EAP requests. Partner with Medical Planning & Operations to support Clinical Operations, serving as key point of contact in site selection, site engagement, study enrollment, and in select cases, study closing. Partner with Medical Outreach to develop and implement global medical engagement plan. Collaborate with Global Marketing to define key stakeholder engagement strategy and oversee engagement activities of global KOLs, including leading / facilitating advisory board meetings. Support Medical Communication and Training to develop and deliver high quality scientific and skill-based training to medical team across regions. What are we looking for?. The successful candidate will possess the following capabilities and characteristics: MD, PhD in life sciences, or PharmD. Located in the greater Boston area; candidates working remotely must be willing to relocate to the greater Boston area by end of 2021. 5+ years of demonstrated high-level professional knowledge and skills in the areas of medical affairs and/or life sciences industry. 3+ years of leadership experience in a matrix environment required. Demonstrated reputation as a well-respected, dynamic leader with strong collaboration skills. Prior experience in the rare disease and/or pulmonary therapeutic area preferred but not required. Expertise in evidence generation with an understanding of key regulatory bodies highly desired. Strong written and verbal communication skills as well as strong leadership and interpersonal skills. Capable of managing shifting priorities in a rapidly changing and environment. Travel will be required (approximately 25%). How will you grow with us?. This role provides an exciting opportunity to be a key player in furthering the company's goal of becoming a leader in the pulmonary space. As a rapidly growing company with multiple assets in development and key regulatory milestones on the horizon, you have an opportunity to leverage your expertise and help shape the growing Medical Affairs team. With one approved product, and an exciting pipeline, Acceleron is in a phase of dynamic growth with opportunities to make a positive impact on patients' lives. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
04/14/2021
Full time
What's in it for you?. The Medical Director, Pulmonary, reporting to the VP, Global Medical Affairs Strategy, will be responsible for providing strategic and scientific leadership for the pulmonary program, including sotatercept, the lead product in late-stage development. The successful candidate will lead the Medical Affairs sub-team to develop global medical strategy for sotatercept, in alignment with pulmonary program strategy. This individual will be accountable for strategic oversight of all medical affairs activities across regions. The successful candidate will serve as the primary point of contact for country medical teams and liaising with counterparts in R&D and Commercial. What will you be doing?: Represent Medical Affairs at the sotatercept program team and global brand team, serving as a strong strategic partner to internal stakeholders. Provide strategic and scientific leadership for the sotatercept program by leading the Medical Affairs sub-team to develop global medical strategy, in alignment with pulmonary program strategy; accountable for effective execution of global medical tactics. Provide strategic oversight for medical affairs activities across regions by partnering with Medical Planning & Operations to track key milestones. Partner with Real-World Evidence team and other stakeholders to develop evidence generation strategy; provide medical oversight for Medical Affairs led studies, including post-hoc analyses of pivotal studies, phase 4 studies, registries; review & approve IIS & local regional study proposals. Provide Medical Affairs input to pivotal study design, ensuring study design address key stakeholder needs. Partner with Medical Communication to ensure timely dissemination of scientific data (e.g. publication and medical congress); review and sign off on abstracts, posters, and publications. Provide medical oversight for key Medical Affairs content such as FAQs. Accountable for authoring EAP protocol, medical review and approval of EAP requests. Partner with Medical Planning & Operations to support Clinical Operations, serving as key point of contact in site selection, site engagement, study enrollment, and in select cases, study closing. Partner with Medical Outreach to develop and implement global medical engagement plan. Collaborate with Global Marketing to define key stakeholder engagement strategy and oversee engagement activities of global KOLs, including leading / facilitating advisory board meetings. Support Medical Communication and Training to develop and deliver high quality scientific and skill-based training to medical team across regions. What are we looking for?. The successful candidate will possess the following capabilities and characteristics: MD, PhD in life sciences, or PharmD. Located in the greater Boston area; candidates working remotely must be willing to relocate to the greater Boston area by end of 2021. 5+ years of demonstrated high-level professional knowledge and skills in the areas of medical affairs and/or life sciences industry. 3+ years of leadership experience in a matrix environment required. Demonstrated reputation as a well-respected, dynamic leader with strong collaboration skills. Prior experience in the rare disease and/or pulmonary therapeutic area preferred but not required. Expertise in evidence generation with an understanding of key regulatory bodies highly desired. Strong written and verbal communication skills as well as strong leadership and interpersonal skills. Capable of managing shifting priorities in a rapidly changing and environment. Travel will be required (approximately 25%). How will you grow with us?. This role provides an exciting opportunity to be a key player in furthering the company's goal of becoming a leader in the pulmonary space. As a rapidly growing company with multiple assets in development and key regulatory milestones on the horizon, you have an opportunity to leverage your expertise and help shape the growing Medical Affairs team. With one approved product, and an exciting pipeline, Acceleron is in a phase of dynamic growth with opportunities to make a positive impact on patients' lives. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. This internship position is 100% virtual How you will Achieve More with Intellia: The Intern, Investor Relations/Corporate Communications will assist to deliver the team's goals, furthering Intellia's mission and strategy through internal/employee engagements and external communications. In this opportunity, your main responsibilities will include: Writing, designing and editing employee communications content, including emails and presentations Supporting public relations and earned media efforts, such as preparing media backgrounders, developing targeted media lists, scheduling media interviews and media monitoring Building digital/social media content, such as drafting calendars and support related activities Maintaining SharePoint-based intranet site and conduct ad hoc research projects Assisting in the coordination and tracking of investor calls, banking conferences, and non-deal roadshows Working collaboratively with partner agencies and internal business partners (e.g. HR, Operations, IT, etc.) to manage key aspects of Intellia's internal communications infrastructure Performing special projects and/or other functions to support the business About You: Do you describe yourself as detailed oriented, collaborative, and enjoy working in a fast-paced, startup environment? If you are currently enrolled in a Bachelor's degree program in Communications, Marketing, Journalism, Public Relations or Finance/Accounting, we encourage you apply! Our ideal candidate will bring: Strong written and verbal communication skills Attention to detail, including event planning and proofreading Excellent PC skills including familiarity with Word, Excel, and PowerPoint; SharePoint a plus Willingness and ability to take initiative, and to work in a fast-paced environment requiring the ability to juggle multiple tasks Solid interpersonal skills and team orientation Meet your future team: The IR/Communications team is a small group of passionate professionals with diverse experience and knowledge. Your role will report directly to the Communications Manager. Given the breadth of work on the IR/Communications team, the candidate will have the opportunity to be part of several initiatives that support Intellia's growing pipeline. In addition to the IR/Communications team, you will have the opportunity to be a part of the larger group of people under the Chief Financial Officer, which is comprised of: Procurement, Accounting, Payroll/Equity, IT, Financial Planning & Analysis, and Operations. The team is currently working 100% remote. Therefore, we do not require the intern to be local to Cambridge MA. Although in a virtual environment, the team has made it a priority to continue to foster a sense of community among the team. This includes virtual happy hours, team all-hands, open office hours, game nights, and more! You can expect to join a hardworking, collaborative environment. We look forward to fostering your skills, learning from your experiences, and creating a memorable summer internship experience! EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
04/14/2021
Full time
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just treat people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together. This internship position is 100% virtual How you will Achieve More with Intellia: The Intern, Investor Relations/Corporate Communications will assist to deliver the team's goals, furthering Intellia's mission and strategy through internal/employee engagements and external communications. In this opportunity, your main responsibilities will include: Writing, designing and editing employee communications content, including emails and presentations Supporting public relations and earned media efforts, such as preparing media backgrounders, developing targeted media lists, scheduling media interviews and media monitoring Building digital/social media content, such as drafting calendars and support related activities Maintaining SharePoint-based intranet site and conduct ad hoc research projects Assisting in the coordination and tracking of investor calls, banking conferences, and non-deal roadshows Working collaboratively with partner agencies and internal business partners (e.g. HR, Operations, IT, etc.) to manage key aspects of Intellia's internal communications infrastructure Performing special projects and/or other functions to support the business About You: Do you describe yourself as detailed oriented, collaborative, and enjoy working in a fast-paced, startup environment? If you are currently enrolled in a Bachelor's degree program in Communications, Marketing, Journalism, Public Relations or Finance/Accounting, we encourage you apply! Our ideal candidate will bring: Strong written and verbal communication skills Attention to detail, including event planning and proofreading Excellent PC skills including familiarity with Word, Excel, and PowerPoint; SharePoint a plus Willingness and ability to take initiative, and to work in a fast-paced environment requiring the ability to juggle multiple tasks Solid interpersonal skills and team orientation Meet your future team: The IR/Communications team is a small group of passionate professionals with diverse experience and knowledge. Your role will report directly to the Communications Manager. Given the breadth of work on the IR/Communications team, the candidate will have the opportunity to be part of several initiatives that support Intellia's growing pipeline. In addition to the IR/Communications team, you will have the opportunity to be a part of the larger group of people under the Chief Financial Officer, which is comprised of: Procurement, Accounting, Payroll/Equity, IT, Financial Planning & Analysis, and Operations. The team is currently working 100% remote. Therefore, we do not require the intern to be local to Cambridge MA. Although in a virtual environment, the team has made it a priority to continue to foster a sense of community among the team. This includes virtual happy hours, team all-hands, open office hours, game nights, and more! You can expect to join a hardworking, collaborative environment. We look forward to fostering your skills, learning from your experiences, and creating a memorable summer internship experience! EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Company Summary: Founded by Flagship Pioneering, Cellarity is the first company developing medicines through an understanding of cell behaviors. The company's broad platform harnesses single-cell technologies and machine learning to digitize and quantify cellular behaviors, unravel the network dynamics that govern those behaviors, and generate medicines that can direct them. Cellarity is using its platform to design medicines targeting the full cellular and molecular complexity of disease, enabling a quantum leap in the success rate and speed of drug discovery, design and development. For additional information, visit . Position Summary : Cellarity, Inc. is seeking a Research Associate with Next Generation Sequencing (NGS) experience to join our Technology group. The candidate will work both independently and as part of a collaborative team to generate data from various genomics-oriented workflows and assist in the optimization and validation of new technologies and procedures. The candidate must be creative, detail oriented, have excellent communication skills and be willing to work in a dynamic entrepreneurial environment. Key Responsibilities : Prepare and sequence a range of NGS library types to support company objectives Work to ensure Production goals and requirements are met Perform experiments to optimize NGS assays Process improvement of current workflows and procedures in creative and effective ways Work independently and as part of a multi-disciplinary team to solve complex problems Effectively document and communicate results and progress Preferred Qualifications : BS/MS (or equivalent) in molecular biology, biochemistry, biology or related field 1+ year(s) of relevant experience, preferably within the biotechnology/pharmaceutical industry Experience with basic molecular biology techniques (e.g., DNA/RNA purification, PCR/RT-PCR amplification, etc.) required Familiarity with the preparation and sequencing of RNA-seq libraries (Illumina) desirable; experience with single-cell RNA-sequencing a plus Demonstrated problem solving skills and ability to troubleshoot technical and scientific issues Ability to work both independently with minimal supervision and cooperatively as part of a team Must have excellent organizational skills and attention to detail Working knowledge of computers, databases, and working in a Windows/Mac environment Strong written and oral communication skills, interpersonal skills and ability to effectively work as part of a team required Must be flexible and willing to work across multiple projects and technology platforms in a fast-paced, rapidly changing scientific environment Flagship Pioneering is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies : Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto
04/14/2021
Full time
Company Summary: Founded by Flagship Pioneering, Cellarity is the first company developing medicines through an understanding of cell behaviors. The company's broad platform harnesses single-cell technologies and machine learning to digitize and quantify cellular behaviors, unravel the network dynamics that govern those behaviors, and generate medicines that can direct them. Cellarity is using its platform to design medicines targeting the full cellular and molecular complexity of disease, enabling a quantum leap in the success rate and speed of drug discovery, design and development. For additional information, visit . Position Summary : Cellarity, Inc. is seeking a Research Associate with Next Generation Sequencing (NGS) experience to join our Technology group. The candidate will work both independently and as part of a collaborative team to generate data from various genomics-oriented workflows and assist in the optimization and validation of new technologies and procedures. The candidate must be creative, detail oriented, have excellent communication skills and be willing to work in a dynamic entrepreneurial environment. Key Responsibilities : Prepare and sequence a range of NGS library types to support company objectives Work to ensure Production goals and requirements are met Perform experiments to optimize NGS assays Process improvement of current workflows and procedures in creative and effective ways Work independently and as part of a multi-disciplinary team to solve complex problems Effectively document and communicate results and progress Preferred Qualifications : BS/MS (or equivalent) in molecular biology, biochemistry, biology or related field 1+ year(s) of relevant experience, preferably within the biotechnology/pharmaceutical industry Experience with basic molecular biology techniques (e.g., DNA/RNA purification, PCR/RT-PCR amplification, etc.) required Familiarity with the preparation and sequencing of RNA-seq libraries (Illumina) desirable; experience with single-cell RNA-sequencing a plus Demonstrated problem solving skills and ability to troubleshoot technical and scientific issues Ability to work both independently with minimal supervision and cooperatively as part of a team Must have excellent organizational skills and attention to detail Working knowledge of computers, databases, and working in a Windows/Mac environment Strong written and oral communication skills, interpersonal skills and ability to effectively work as part of a team required Must be flexible and willing to work across multiple projects and technology platforms in a fast-paced, rapidly changing scientific environment Flagship Pioneering is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies : Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto
What's in it for you?. We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to join the Program Management team and drive projects from research through early clinical development. The ideal candidate will be responsible for actively managing highly technical, cross functional teams to ensure the advancement of programs, managing program scope, timelines, deliverables, risks, decisions and alignment with senior leadership. The candidate will possess a breadth and depth of expertise spanning research through early clinical development, with a strong scientific background and significant early stage drug development experience. This role will require strong leadership, collaboration & communication skills. The candidate will lead cross-functional early development program teams to define the optimal development and regulatory strategy and to drive operational advancement of the program. The candidate will play a key role in day-to-day operations and long-range planning, and will represent the program teams in management settings. Reporting to the Senior Director Program Management Early Pipeline, and working closely with individuals from functions including Research, CMC, Non-Clinical, Medical, Regulatory, and Market Development you will apply your expertise and understanding of drug development to integrate key functional activities, managing program timeline, scope, budget and risks to enable Sr. leadership decisions. What will you be doing?: As part of the Program Management team, build and help to drive high performing, cross-functional teams to promote effective communication (e.g., team meetings, program updates) and ensure integration and alignment of internal subject matter experts. Must be able to lead multiple program teams and subteams, define project strategies, proactively identify and escalate risks, gaps and challenges, and work with teams to develop/test scenarios and risk mitigation plans. Facilitate team meetings, including leading discussions to drive to decision-making; defining and resolving action items to ensure continuity between meetings; developing agendas and meeting minutes. Accountable as the primary contact for program team related information and for obtaining and maintaining a comprehensive knowledge of the program scope, deliverables, timelines, status and key risks. Ability to lead crossfunctional teams in the preparation of early strategic development plans, and represent program teams at governance meetings. Foster strong relationships and support effective and impactful communications with management, team members and functional line managers in order to ensure active management of issues/risks/decisions/opportunities. Maintain program-related documentation, including, but not limited to, program plans and timelines, decision logs, risk management, and project goals, ensuring appropriate archiving and access. Develop, maintain and/or disseminate communications tools, including but not limited to effective team meetings, file sharing sites, program workplans, trackers, team membership lists. Reinforce and support team operating principles, best practices and team building to ensure effective and high-performing teams. What are we looking for?: Degree in life sciences, with at least 8 years of relevant professional experience in the biopharmaceutical industry, including at least 5 years in relevant project/program management roles. Solid understanding of the drug development process. Significant breadth of experience across the early-stage drug development process including discovery, non-clinical, clinical, regulatory, CMC and early commercial functions. Prior experience in biologics desirable; technical R&D acumen required. Recent experience with IND/CTA submissions. Proven track record of leading and driving cross-functional teams in planning and managing early development programs including cross functional deliverables (Research, CMC and Commercial). Experience in a matrixed and/or direct people management role with demonstrated ability to influence without authority. Independent creative thinker and enabler requiring minimum oversight. A self-starter who is pro-active, motivates, and has tact, diplomacy, is a true team player, with excellent leadership skills. Applied knowledge of project management tools and processes. Strong computer skills; skilled at using Word, Excel, PowerPoint, Microsoft Project and Enterprise Resource Planning (ERP) tools. Strong written and oral communication skills. Ability to work collaboratively with others across all functions and levels within the organization. Excellent organizational skills and comfort with multi-tasking in a fast-paced environment. How will you grow with us?. You will be joining a growing and advancing company with an active pipeline. With a focus on early development, you will have the opportunity to follow programs from research and/or pre-dev into the clinic and towards POC studies. If you are looking to be a part of an innovative and fast-paced environment, join our team!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, REBLOZYL (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States and Europe for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit . 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04/14/2021
Full time
What's in it for you?. We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to join the Program Management team and drive projects from research through early clinical development. The ideal candidate will be responsible for actively managing highly technical, cross functional teams to ensure the advancement of programs, managing program scope, timelines, deliverables, risks, decisions and alignment with senior leadership. The candidate will possess a breadth and depth of expertise spanning research through early clinical development, with a strong scientific background and significant early stage drug development experience. This role will require strong leadership, collaboration & communication skills. The candidate will lead cross-functional early development program teams to define the optimal development and regulatory strategy and to drive operational advancement of the program. The candidate will play a key role in day-to-day operations and long-range planning, and will represent the program teams in management settings. Reporting to the Senior Director Program Management Early Pipeline, and working closely with individuals from functions including Research, CMC, Non-Clinical, Medical, Regulatory, and Market Development you will apply your expertise and understanding of drug development to integrate key functional activities, managing program timeline, scope, budget and risks to enable Sr. leadership decisions. What will you be doing?: As part of the Program Management team, build and help to drive high performing, cross-functional teams to promote effective communication (e.g., team meetings, program updates) and ensure integration and alignment of internal subject matter experts. Must be able to lead multiple program teams and subteams, define project strategies, proactively identify and escalate risks, gaps and challenges, and work with teams to develop/test scenarios and risk mitigation plans. Facilitate team meetings, including leading discussions to drive to decision-making; defining and resolving action items to ensure continuity between meetings; developing agendas and meeting minutes. Accountable as the primary contact for program team related information and for obtaining and maintaining a comprehensive knowledge of the program scope, deliverables, timelines, status and key risks. Ability to lead crossfunctional teams in the preparation of early strategic development plans, and represent program teams at governance meetings. Foster strong relationships and support effective and impactful communications with management, team members and functional line managers in order to ensure active management of issues/risks/decisions/opportunities. Maintain program-related documentation, including, but not limited to, program plans and timelines, decision logs, risk management, and project goals, ensuring appropriate archiving and access. Develop, maintain and/or disseminate communications tools, including but not limited to effective team meetings, file sharing sites, program workplans, trackers, team membership lists. Reinforce and support team operating principles, best practices and team building to ensure effective and high-performing teams. What are we looking for?: Degree in life sciences, with at least 8 years of relevant professional experience in the biopharmaceutical industry, including at least 5 years in relevant project/program management roles. Solid understanding of the drug development process. Significant breadth of experience across the early-stage drug development process including discovery, non-clinical, clinical, regulatory, CMC and early commercial functions. Prior experience in biologics desirable; technical R&D acumen required. Recent experience with IND/CTA submissions. Proven track record of leading and driving cross-functional teams in planning and managing early development programs including cross functional deliverables (Research, CMC and Commercial). Experience in a matrixed and/or direct people management role with demonstrated ability to influence without authority. Independent creative thinker and enabler requiring minimum oversight. A self-starter who is pro-active, motivates, and has tact, diplomacy, is a true team player, with excellent leadership skills. Applied knowledge of project management tools and processes. Strong computer skills; skilled at using Word, Excel, PowerPoint, Microsoft Project and Enterprise Resource Planning (ERP) tools. Strong written and oral communication skills. Ability to work collaboratively with others across all functions and levels within the organization. Excellent organizational skills and comfort with multi-tasking in a fast-paced environment. How will you grow with us?. You will be joining a growing and advancing company with an active pipeline. With a focus on early development, you will have the opportunity to follow programs from research and/or pre-dev into the clinic and towards POC studies. If you are looking to be a part of an innovative and fast-paced environment, join our team!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, REBLOZYL (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States and Europe for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit . 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What's in it for you?. Reporting directly to the Senior Manager, Contracts and Legal Operations the corporate paralegal will be a key member of the legal team who assists with corporate governance, subsidiary management, legal document management and other general legal matters. What will you be doing?: Support the Legal team in all corporate governance matters and management of entities worldwide. Manage Acceleron's corporate structure worldwide, including legal entity formation, merger and dissolution processes, and ongoing requirements with local legal requirements. Draft and review documents related to the corporation's entities worldwide, including formation documents, board and shareholder meeting minutes, corporate resolutions, and other compliance documentation. Maintain legal entity records, including minute books, for all entities worldwide. Prepare board books and other relevant board materials in advance of corporate board meetings and distribute to relevant board and committee members. Track and monitor employee and executive 10b5-1 plans. Maintain and manage the company's preclearance and blackout lists and serve as the first contact for internal employees when starting the preclearance process. Coordinate notarization and legalization of documents. Maintain electronic copies of legal documents that support the corporation. Assist in the drafting and submission of SEC filings and gathering information related to such SEC filings (e.g. D&O Questionnaires). Assist Legal Operations with the implementation of new software and technologies brought in house and departmental budget management items. Assist where needed in other aspects of the corporate legal team. What are we looking for?: Experience working for a public company is preferred: BA or Legal Assistant/Paralegal degree with at least 3 years of experience as a Paralegal, or equivalent experience. Experience in corporate entity management and maintenance. Ability to understand, interpret and explain legal principles. High proficiency in Microsoft Office applications required. Must be self-motivated and able to work independently. Excellent customer service skills and communication skills. Ability to meet deadlines timely follow-up and follow-through. Ability to take on several projects simultaneously. How will you grow with us?. This role is ideal for an individual looking to make a difference from day one on a corporate legal team that prides itself on fast and accurate execution. This department is committed to developing its employees into the areas that interest them the most. The paralegal will have a hand in virtually all of the matters the corporate legal team tends to (corporate governance, entity management, document management, legal operations, etc.) and, for the right individual, can serve as a way to determine which area of an in house corporate legal team interests them most and subsequently specialize in as they develop with our organization. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
04/14/2021
Full time
What's in it for you?. Reporting directly to the Senior Manager, Contracts and Legal Operations the corporate paralegal will be a key member of the legal team who assists with corporate governance, subsidiary management, legal document management and other general legal matters. What will you be doing?: Support the Legal team in all corporate governance matters and management of entities worldwide. Manage Acceleron's corporate structure worldwide, including legal entity formation, merger and dissolution processes, and ongoing requirements with local legal requirements. Draft and review documents related to the corporation's entities worldwide, including formation documents, board and shareholder meeting minutes, corporate resolutions, and other compliance documentation. Maintain legal entity records, including minute books, for all entities worldwide. Prepare board books and other relevant board materials in advance of corporate board meetings and distribute to relevant board and committee members. Track and monitor employee and executive 10b5-1 plans. Maintain and manage the company's preclearance and blackout lists and serve as the first contact for internal employees when starting the preclearance process. Coordinate notarization and legalization of documents. Maintain electronic copies of legal documents that support the corporation. Assist in the drafting and submission of SEC filings and gathering information related to such SEC filings (e.g. D&O Questionnaires). Assist Legal Operations with the implementation of new software and technologies brought in house and departmental budget management items. Assist where needed in other aspects of the corporate legal team. What are we looking for?: Experience working for a public company is preferred: BA or Legal Assistant/Paralegal degree with at least 3 years of experience as a Paralegal, or equivalent experience. Experience in corporate entity management and maintenance. Ability to understand, interpret and explain legal principles. High proficiency in Microsoft Office applications required. Must be self-motivated and able to work independently. Excellent customer service skills and communication skills. Ability to meet deadlines timely follow-up and follow-through. Ability to take on several projects simultaneously. How will you grow with us?. This role is ideal for an individual looking to make a difference from day one on a corporate legal team that prides itself on fast and accurate execution. This department is committed to developing its employees into the areas that interest them the most. The paralegal will have a hand in virtually all of the matters the corporate legal team tends to (corporate governance, entity management, document management, legal operations, etc.) and, for the right individual, can serve as a way to determine which area of an in house corporate legal team interests them most and subsequently specialize in as they develop with our organization. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
Location: US-MA-Cambridge ID: 2 # of Openings : 1 Category: Research & Development Address: 10 Wilson Road Overview Deerfield Management is an investment management firm committed to improving healthcare through investment, information and philanthropy. We have just launched a new company called Civetta Therapeutics located in Cambridge, MA that was founded by William Sellers (Broad Institute and Dana-Farber Cancer Institute) and Eric Fischer (Dana Farber Cancer Institute and Harvard Medical School). We are looking to engage a high-quality team of researchers to advance new medicines through small molecule intervention targeting propeller domains with the goal of developing important therapeutics for cancer and other indications. If you are a talented life sciences professional that can bring significant energy, passion and talent to the team, we welcome the opportunity to consider you for a position in this exciting, new company committed to thorough, mechanistically-driven science. The position The Research Associate / Associate Scientist will be an integral member of the Biology team at Civetta Therapeutics. The Biology team is responsible for identifying and validating molecular targets, evaluating novel drug candidates, and providing forward-thinking approaches to advance our pre-clinical pipeline and proprietary platform. The Research Associate / Associate Scientist will be responsible for designing and conducting cellular assays, determining the potency and mechanism of action of small molecule compounds, and contributing to the build-out of the platform technology. This is a hands-on position for an experienced lab scientist who enjoys working in the lab. The Research Associate / Associate Scientist must have excellent communication skills and be able to work with a positive attitude in a dynamic, fast-paced, team environment focused on high quality science to propel us in delivering innovative cancer therapeutics. Responsibilities Key responsibilities Create, develop and validate quantitative cell-based assays to address mechanistic and functional needs for pipeline projects and platform Establish and conduct robust screening assays to support lead optimization programs Spend at least 85% of one's time at the bench Collaborate with colleagues in the cross-functional project team setting to ensure assays meet the project needs and results are appropriately interpreted and communicated Participate in meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies Maintains laboratory notebook in a complete, consistent and concise manner in accordance with company policies and practices Qualifications Qualifications BS/MS in Molecular/Cellular Biology or Biochemistry with 2-6 years of hands-on cell biology experience in a biotech/pharma setting. Extensive experience with mammalian cell culture; creating, developing, and running cellular assays. Expertise in engineering cell lines to express or knock-down genes of interest, and interrogating biological pathways using chemical biology tools. Experience with CRISPR gene editing and functional genomics screening is strongly preferred but not required. Experience with general molecular biological techniques including molecular cloning, PCR, RT-qPCR, ELISA, proximity-based assays, immunoprecipitations, Western blotting. Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, CROs, and scientific advisors. Highly organized with excellent analytical, documentation and multi-tasking skills. Enthusiastic, self-motivated individual wanting to work in the fast-paced and dynamic environment of a startup. William Sellers is a core institute member of the Broad Institute of MIT and Harvard, a faculty member at Harvard Medical School, and faculty member and senior advisor to the president for experimental therapeutics at the Dana-Farber Cancer Institute. Eric Fischer is an Associate Professor in the Department of Biological Chemistry and Molecular Pharmacology at Harvard Medical School and an Independent Investigator, Dana-Farber Cancer Institute. Civetta Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI PI
04/13/2021
Full time
Location: US-MA-Cambridge ID: 2 # of Openings : 1 Category: Research & Development Address: 10 Wilson Road Overview Deerfield Management is an investment management firm committed to improving healthcare through investment, information and philanthropy. We have just launched a new company called Civetta Therapeutics located in Cambridge, MA that was founded by William Sellers (Broad Institute and Dana-Farber Cancer Institute) and Eric Fischer (Dana Farber Cancer Institute and Harvard Medical School). We are looking to engage a high-quality team of researchers to advance new medicines through small molecule intervention targeting propeller domains with the goal of developing important therapeutics for cancer and other indications. If you are a talented life sciences professional that can bring significant energy, passion and talent to the team, we welcome the opportunity to consider you for a position in this exciting, new company committed to thorough, mechanistically-driven science. The position The Research Associate / Associate Scientist will be an integral member of the Biology team at Civetta Therapeutics. The Biology team is responsible for identifying and validating molecular targets, evaluating novel drug candidates, and providing forward-thinking approaches to advance our pre-clinical pipeline and proprietary platform. The Research Associate / Associate Scientist will be responsible for designing and conducting cellular assays, determining the potency and mechanism of action of small molecule compounds, and contributing to the build-out of the platform technology. This is a hands-on position for an experienced lab scientist who enjoys working in the lab. The Research Associate / Associate Scientist must have excellent communication skills and be able to work with a positive attitude in a dynamic, fast-paced, team environment focused on high quality science to propel us in delivering innovative cancer therapeutics. Responsibilities Key responsibilities Create, develop and validate quantitative cell-based assays to address mechanistic and functional needs for pipeline projects and platform Establish and conduct robust screening assays to support lead optimization programs Spend at least 85% of one's time at the bench Collaborate with colleagues in the cross-functional project team setting to ensure assays meet the project needs and results are appropriately interpreted and communicated Participate in meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies Maintains laboratory notebook in a complete, consistent and concise manner in accordance with company policies and practices Qualifications Qualifications BS/MS in Molecular/Cellular Biology or Biochemistry with 2-6 years of hands-on cell biology experience in a biotech/pharma setting. Extensive experience with mammalian cell culture; creating, developing, and running cellular assays. Expertise in engineering cell lines to express or knock-down genes of interest, and interrogating biological pathways using chemical biology tools. Experience with CRISPR gene editing and functional genomics screening is strongly preferred but not required. Experience with general molecular biological techniques including molecular cloning, PCR, RT-qPCR, ELISA, proximity-based assays, immunoprecipitations, Western blotting. Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, CROs, and scientific advisors. Highly organized with excellent analytical, documentation and multi-tasking skills. Enthusiastic, self-motivated individual wanting to work in the fast-paced and dynamic environment of a startup. William Sellers is a core institute member of the Broad Institute of MIT and Harvard, a faculty member at Harvard Medical School, and faculty member and senior advisor to the president for experimental therapeutics at the Dana-Farber Cancer Institute. Eric Fischer is an Associate Professor in the Department of Biological Chemistry and Molecular Pharmacology at Harvard Medical School and an Independent Investigator, Dana-Farber Cancer Institute. Civetta Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI PI
What's in it for you?. Reporting to the VP, Corporate Controller, the Associate Director, Cost Accounting will initially be responsible for the build out of the Company's functions for inventory and cost accounting while overseeing the existing manufacturing and CMC-related financial close activities. Upon Commercial Launch, this role will transition to leading the financial close accounting, analysis, and reporting for inventory and cost of goods sold. Additionally, the role involves working cross-functionally with the Financial Planning & Analysis, Supply Chain, IT, and Commercial departments to effectively manage inventory deployment of raw material, drug substance, drug product, and finished goods. If you are a seasoned professional interested in a highly visible role that is excited to build out a growing Finance organization's inventory systems, processes, and controls then this role is perfect for you!. What will you be doing?: Designing and implementing the Company's inventorying costing software system and methodology, ERP system integration, controls, and inventory accounting policy leading up to commercial launch. Developing cost accounting strategies for managing production schedules, inventory movements, supplier reconciliations, and related matters to ensure inventory and cost of goods are fairly stated. Affirming the completeness and accuracy of month-end close tasks by overseeing the. review of all related journal entries as well as monthly account reconciliations related to inventory, manufacturing, and other CMC areas: Developing and monitoring the accounting for inventory related reserves (including excess & obsolescence), as well as purchasing and manufacturing variances. Actively participating in cross functional commercial launch coordination meetings to prepare and execute on-time deployment of inventory. Designing and maintaining a suite of SOX controls related to inventory and costing. Managing inventory reconciliation and/or cycle counting efforts in coordination with relevant departments to review and resolve inventory discrepancies. Collaborate with Supply Chain team in creating and maintaining inventory forecasts and projections for key materials, as well as presenting these summaries to cross-functional teams. Collaborate with Supply Chain team in developing, maintaining, and updating cost allocation and inventory models to define optimized inventory targets and reorder points. Utilizing and adapting available ERP and reporting systems to effectively monitor inventory coverage, issue status reports, and adjust deployment plan priorities. What are we looking for?: S. in Finance or Accounting; Life Sciences industry and public company experience, as well as credentials such as CPA, MBA, CSCP, and/or CPIM certifications are highly preferred. 8-10 years' industry experience in Supply Chain and/or Inventory Management activities, with specific experience in commercial launch a significant plus. Comprehensive and strategic understanding of accounting principles and Sarbanes-Oxley. Demonstrated strong working knowledge of inventory management, cost assessments, and analysis of cost-related data and models. Strong analytical and data management skills (i.e. Microsoft Excel, Access). Proven leadership in developing, implementing, and automating cost accounting models and inventory models. Oracle Fusion experience preferred. Experience in managing diverse project activities with pharmaceutical raw materials, drug substance, and drug product supply is preferred. Ability to communicate effectively across a number of disciplines and experience levels, including to senior management. Ability to support and lead a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals. How will you grow with us?. Our active pipeline and fast pace provide an exciting opportunity to join a dynamic team in a hands-on role where you will be able to significantly contribute to the strategy and initiatives within the Finance group. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. This opportunity will allow you to develop your skills by taking on new challenges and partnering with sharp and dedicated team members who will motivate and support you. Join our team and apply today!.
04/13/2021
Full time
What's in it for you?. Reporting to the VP, Corporate Controller, the Associate Director, Cost Accounting will initially be responsible for the build out of the Company's functions for inventory and cost accounting while overseeing the existing manufacturing and CMC-related financial close activities. Upon Commercial Launch, this role will transition to leading the financial close accounting, analysis, and reporting for inventory and cost of goods sold. Additionally, the role involves working cross-functionally with the Financial Planning & Analysis, Supply Chain, IT, and Commercial departments to effectively manage inventory deployment of raw material, drug substance, drug product, and finished goods. If you are a seasoned professional interested in a highly visible role that is excited to build out a growing Finance organization's inventory systems, processes, and controls then this role is perfect for you!. What will you be doing?: Designing and implementing the Company's inventorying costing software system and methodology, ERP system integration, controls, and inventory accounting policy leading up to commercial launch. Developing cost accounting strategies for managing production schedules, inventory movements, supplier reconciliations, and related matters to ensure inventory and cost of goods are fairly stated. Affirming the completeness and accuracy of month-end close tasks by overseeing the. review of all related journal entries as well as monthly account reconciliations related to inventory, manufacturing, and other CMC areas: Developing and monitoring the accounting for inventory related reserves (including excess & obsolescence), as well as purchasing and manufacturing variances. Actively participating in cross functional commercial launch coordination meetings to prepare and execute on-time deployment of inventory. Designing and maintaining a suite of SOX controls related to inventory and costing. Managing inventory reconciliation and/or cycle counting efforts in coordination with relevant departments to review and resolve inventory discrepancies. Collaborate with Supply Chain team in creating and maintaining inventory forecasts and projections for key materials, as well as presenting these summaries to cross-functional teams. Collaborate with Supply Chain team in developing, maintaining, and updating cost allocation and inventory models to define optimized inventory targets and reorder points. Utilizing and adapting available ERP and reporting systems to effectively monitor inventory coverage, issue status reports, and adjust deployment plan priorities. What are we looking for?: S. in Finance or Accounting; Life Sciences industry and public company experience, as well as credentials such as CPA, MBA, CSCP, and/or CPIM certifications are highly preferred. 8-10 years' industry experience in Supply Chain and/or Inventory Management activities, with specific experience in commercial launch a significant plus. Comprehensive and strategic understanding of accounting principles and Sarbanes-Oxley. Demonstrated strong working knowledge of inventory management, cost assessments, and analysis of cost-related data and models. Strong analytical and data management skills (i.e. Microsoft Excel, Access). Proven leadership in developing, implementing, and automating cost accounting models and inventory models. Oracle Fusion experience preferred. Experience in managing diverse project activities with pharmaceutical raw materials, drug substance, and drug product supply is preferred. Ability to communicate effectively across a number of disciplines and experience levels, including to senior management. Ability to support and lead a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals. How will you grow with us?. Our active pipeline and fast pace provide an exciting opportunity to join a dynamic team in a hands-on role where you will be able to significantly contribute to the strategy and initiatives within the Finance group. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. This opportunity will allow you to develop your skills by taking on new challenges and partnering with sharp and dedicated team members who will motivate and support you. Join our team and apply today!.
What's in it for you?. In this role, you will manage the internal team to develop analytical strategies and guidelines for integrated early and late stage development activities in support of biologics commercialization. You will also support and ensure proper execution of analytical method development and transfer to CROs and CMOs; coordinate, monitor and evaluate project progression, timelines and quality of deliverables; lead product characterization; and set scientifically justifiable comparability strategies. As a key member of the AD-QC team, you will collaborate effectively and transparently with team members and functional leaders in the areas of Analytical Development and Quality Control, Drug Substance Development, Drug Product Development, CMC Project Management, Quality Assurance, Regulatory Affairs, and Clinical and Commercial Manufacturing. What will you be doing?: Develop analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies and release/stability criteria for various scenarios including accelerated product development. Support all CMC filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs and track analytical development /QC commitments. Actively participate in CMC regulatory writing activities for analytical development function, assist in review of regulatory filings in INDs/IMPDs, CTAs and BLAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements. Lead tech transfer of methods to QC testing facility and to CRO/CMO's. Manage and oversee analytical activities performed at CROs/CDMOs associated with method development and characterization for drug substance, drug product and reference standards. Develop and establish the strategies for product characterization with a focus on CQA assessment, comparability and lead characterization activities. Collaborate with upstream and downstream process and formulation functions to ensure strong cross functional collaborations and integrated process and product development and characterization. Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.). Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. Establish and implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results. Qualifications and Job Requirements: MS or Ph.D. in chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical discipline with a minimum of 10+ years of biopharmaceutical analytical experience with recombinant biologic molecules or Masters in a similar discipline with 15+ years of the previously mentioned experience. Significant and established experience in the biopharmaceutical industry with relevant experience in late stage product and process characterization for therapeutic proteins /mAbs. Significant experience with methods used for biopharmaceutical characterization as well as a thorough knowledge of structure-function relationship of therapeutic proteins. Demonstrated experience and knowledge in tech transfer of methods and life cycle management is a must. Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization including HPLC based separation methods, peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies. Strong communication skills: ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience. Proven ability to work with at a high level of integrity, accuracy, and attention to detail. Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions. Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making. Resourceful, enthusiastic, and results-oriented. How will you grow with us?. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. This will be a time of dynamic growth, requiring timely, strategic decision making and execution. The Analytical Development group is constantly working on critical projects and activities and is looking for a team member who is excited about our science and initiatives. By joining our innovative and fast-paced environment, you will have the opportunity to contribute to the strategy of the Analytical Development group and take molecules from discovery through commercialization. Join our team!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT: .
04/13/2021
Full time
What's in it for you?. In this role, you will manage the internal team to develop analytical strategies and guidelines for integrated early and late stage development activities in support of biologics commercialization. You will also support and ensure proper execution of analytical method development and transfer to CROs and CMOs; coordinate, monitor and evaluate project progression, timelines and quality of deliverables; lead product characterization; and set scientifically justifiable comparability strategies. As a key member of the AD-QC team, you will collaborate effectively and transparently with team members and functional leaders in the areas of Analytical Development and Quality Control, Drug Substance Development, Drug Product Development, CMC Project Management, Quality Assurance, Regulatory Affairs, and Clinical and Commercial Manufacturing. What will you be doing?: Develop analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies and release/stability criteria for various scenarios including accelerated product development. Support all CMC filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs and track analytical development /QC commitments. Actively participate in CMC regulatory writing activities for analytical development function, assist in review of regulatory filings in INDs/IMPDs, CTAs and BLAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements. Lead tech transfer of methods to QC testing facility and to CRO/CMO's. Manage and oversee analytical activities performed at CROs/CDMOs associated with method development and characterization for drug substance, drug product and reference standards. Develop and establish the strategies for product characterization with a focus on CQA assessment, comparability and lead characterization activities. Collaborate with upstream and downstream process and formulation functions to ensure strong cross functional collaborations and integrated process and product development and characterization. Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.). Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. Establish and implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results. Qualifications and Job Requirements: MS or Ph.D. in chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical discipline with a minimum of 10+ years of biopharmaceutical analytical experience with recombinant biologic molecules or Masters in a similar discipline with 15+ years of the previously mentioned experience. Significant and established experience in the biopharmaceutical industry with relevant experience in late stage product and process characterization for therapeutic proteins /mAbs. Significant experience with methods used for biopharmaceutical characterization as well as a thorough knowledge of structure-function relationship of therapeutic proteins. Demonstrated experience and knowledge in tech transfer of methods and life cycle management is a must. Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization including HPLC based separation methods, peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies. Strong communication skills: ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience. Proven ability to work with at a high level of integrity, accuracy, and attention to detail. Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions. Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making. Resourceful, enthusiastic, and results-oriented. How will you grow with us?. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. This will be a time of dynamic growth, requiring timely, strategic decision making and execution. The Analytical Development group is constantly working on critical projects and activities and is looking for a team member who is excited about our science and initiatives. By joining our innovative and fast-paced environment, you will have the opportunity to contribute to the strategy of the Analytical Development group and take molecules from discovery through commercialization. Join our team!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT: .
What's in it for you?. We are seeking an experienced and talented individual who thrives in a dynamic, collaborative, fast-paced, and team-centric environment. As a Manager of our Trial Master File (TMF) team, you will oversee and manage all aspects of eTMF activities for assigned global clinical trials. You will collaborate with cross-functional team members, contract research organizations and partnering vendors to ensure continuous process improvements and inspection readiness in TMF. What will you be doing?: Management and oversight of TMF study initiation activities (e.g., TMF set-up and metrics monitoring through-out study life, TMF timelines, project presentations, kick-off meeting TMF trainings, quality management, migrations, and archive). Work proactively and prospectively with Clinical Trial Managers, TMF contributors, and TMF document owners at Trial, Country, and Site levels to ensure inspection readiness. Manage special projects with ability to solve TMF challenges. Author and contribute to the development of SOPs, work instructions, TMF Plans, and other tools to ensure compliance with applicable regulations, policies, and practices. What are we looking for?: Bachelor's degree required; Master's degree preferred. Minimum 5 years of pharmaceutical industry experience related to clinical trial management. Strong skill set in e-TMF technology and reporting. Significant understanding of, and experience with the DIA TMF Reference Model. Previous experience in managing and archiving clinical trial related documentation. Possess a high degree of ingenuity and the ability to work and lead cross-functional teams/studies/initiatives. Extensive understanding of regulatory requirements, guidances, and industry standards that govern TMF. Excellent organizational skills. Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, Visio etc.). Ability to work full-time, on-site, or remotely during core corporate hours at the Acceleron offices in Cambridge. If full time remote, trips to the office will be required on a regularly scheduled basis or as needed to support on-site audits and/or inspections. How will you grow with us?. As a member of the TMF team, this role provides an exciting opportunity to impact the compliance and success of multiple programs. This role provides a tremendous opportunity to gain experience in TMF in a dynamic, fast-paced, and innovative company. Join our team to achieve shared goals while having Too Much Fun along the way!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
04/13/2021
Full time
What's in it for you?. We are seeking an experienced and talented individual who thrives in a dynamic, collaborative, fast-paced, and team-centric environment. As a Manager of our Trial Master File (TMF) team, you will oversee and manage all aspects of eTMF activities for assigned global clinical trials. You will collaborate with cross-functional team members, contract research organizations and partnering vendors to ensure continuous process improvements and inspection readiness in TMF. What will you be doing?: Management and oversight of TMF study initiation activities (e.g., TMF set-up and metrics monitoring through-out study life, TMF timelines, project presentations, kick-off meeting TMF trainings, quality management, migrations, and archive). Work proactively and prospectively with Clinical Trial Managers, TMF contributors, and TMF document owners at Trial, Country, and Site levels to ensure inspection readiness. Manage special projects with ability to solve TMF challenges. Author and contribute to the development of SOPs, work instructions, TMF Plans, and other tools to ensure compliance with applicable regulations, policies, and practices. What are we looking for?: Bachelor's degree required; Master's degree preferred. Minimum 5 years of pharmaceutical industry experience related to clinical trial management. Strong skill set in e-TMF technology and reporting. Significant understanding of, and experience with the DIA TMF Reference Model. Previous experience in managing and archiving clinical trial related documentation. Possess a high degree of ingenuity and the ability to work and lead cross-functional teams/studies/initiatives. Extensive understanding of regulatory requirements, guidances, and industry standards that govern TMF. Excellent organizational skills. Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, Visio etc.). Ability to work full-time, on-site, or remotely during core corporate hours at the Acceleron offices in Cambridge. If full time remote, trips to the office will be required on a regularly scheduled basis or as needed to support on-site audits and/or inspections. How will you grow with us?. As a member of the TMF team, this role provides an exciting opportunity to impact the compliance and success of multiple programs. This role provides a tremendous opportunity to gain experience in TMF in a dynamic, fast-paced, and innovative company. Join our team to achieve shared goals while having Too Much Fun along the way!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines. We are looking for enthusiastic scientists to forward our novel targeted gene therapy platform. The candidate will be working in vibrant research environment with cross-functional connections to technical operations and pharmacology groups. Candidates should have the vision to do creative things and the determination to execute that vision. DUTIES AND RESPONSIBILITIES Develop Sana gene therapy platform for use in various cell systems Characterization of gene expression and cell-identity markers in mammalian cells using flow cytometry, microscopy, and qPCR Design and engineering of protein scaffolds for targeted gene therapy Assay development for testing novel protein vectors that support our platform technology Provides mentorship to others by leading in presentations and scientific discussion Design and execute in vitro studies to demonstrate viral vector-mediated gene transfer in primary cell systems Understand and apply relevant scientific literature to the design of experimental protocols. This may include literature from outside of the Scientist's primary field of research QUALIFICATIONS Basic Qualifications PhD in scientific discipline with at least 2+ years with laboratory experience in an academic or industry setting or a Masters' degree in a scientific specialty with a minimum of five years of experience and proven proficiency in independent research and in the design of laboratory experiments and techniques may provide the necessary experience. A strong self-starter, independent thinker, with a strong attention to detail Well versed in a wide array of laboratory techniques and experienced in their use. Strong publication record from graduate and post doctoral work is expected Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with a range of collaborators including research associates, technical experts, computational biologists, cell biologists, and therapeutic teams Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Experience with gene therapy approaches, including lentiviral transduction Preferred Qualifications Preferred Qualifications include: Experience in antibody discovery or engineering is a plus Expertise in structural virology or viral cell biology is a plus Advance experience in protein engineering is a plus, including relevant skills: Ability to analyze sequence data in support of protein design Familiarity with experimental & empirical approaches (ideally high throughput) for testing computational protein predictions (i.e. must be able to interface with these experimental teams) Demonstrated ability in working with highly skilled teams in a fast-paced, collaborative, and technical environment PHYSICAL REQUIREMENTS Carrying, handling and reaching for objects up to 25 lbs. Prolonged standing and/or sitting Exposure to hazardous/toxic/dangerous chemicals Manual dexterity required to operate office and lab equipment
04/13/2021
Full time
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines. We are looking for enthusiastic scientists to forward our novel targeted gene therapy platform. The candidate will be working in vibrant research environment with cross-functional connections to technical operations and pharmacology groups. Candidates should have the vision to do creative things and the determination to execute that vision. DUTIES AND RESPONSIBILITIES Develop Sana gene therapy platform for use in various cell systems Characterization of gene expression and cell-identity markers in mammalian cells using flow cytometry, microscopy, and qPCR Design and engineering of protein scaffolds for targeted gene therapy Assay development for testing novel protein vectors that support our platform technology Provides mentorship to others by leading in presentations and scientific discussion Design and execute in vitro studies to demonstrate viral vector-mediated gene transfer in primary cell systems Understand and apply relevant scientific literature to the design of experimental protocols. This may include literature from outside of the Scientist's primary field of research QUALIFICATIONS Basic Qualifications PhD in scientific discipline with at least 2+ years with laboratory experience in an academic or industry setting or a Masters' degree in a scientific specialty with a minimum of five years of experience and proven proficiency in independent research and in the design of laboratory experiments and techniques may provide the necessary experience. A strong self-starter, independent thinker, with a strong attention to detail Well versed in a wide array of laboratory techniques and experienced in their use. Strong publication record from graduate and post doctoral work is expected Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with a range of collaborators including research associates, technical experts, computational biologists, cell biologists, and therapeutic teams Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Experience with gene therapy approaches, including lentiviral transduction Preferred Qualifications Preferred Qualifications include: Experience in antibody discovery or engineering is a plus Expertise in structural virology or viral cell biology is a plus Advance experience in protein engineering is a plus, including relevant skills: Ability to analyze sequence data in support of protein design Familiarity with experimental & empirical approaches (ideally high throughput) for testing computational protein predictions (i.e. must be able to interface with these experimental teams) Demonstrated ability in working with highly skilled teams in a fast-paced, collaborative, and technical environment PHYSICAL REQUIREMENTS Carrying, handling and reaching for objects up to 25 lbs. Prolonged standing and/or sitting Exposure to hazardous/toxic/dangerous chemicals Manual dexterity required to operate office and lab equipment
