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125 jobs found in Cambridge

Insurance Agent
Family First Life West Coast Cambridge, Massachusetts
About Family First Life Family First Life prides itself on the respect, mentorship, and selfless leaders and agents working with us, starting from the top down with our President and CEO, Shawn Meaike. We are looking for Agents who have experience in the insurance industry that are looking to earn what they are worth and have unlimited potential to grow an agency along side us at FFL. The Agents we bring on board must be disciplined and willing to earn the average insurance agent's $122,000 + annual income, by following our structured training and lead program. Our mission at FFL is to make the families we protect and the families of our agents our number one priority. We can help our clients with Final Expense Insurance, Retirement Planning, Mortgage Protection, Medicare Supplements and more. To accomplish putting our clients first we work with multiple A rated insurance carriers to ensure we put our clients in the best possible protection. We give everything we have to earn trust and loyalty with our clients and our agents, starting with an aggressive commission structure so you can take care of your families as well as your clients. If you believe you have the drive, work ethic, experience, and ability to learn and be mentored to become a manager and business partner to grow with us, we are interested in getting to know you. We are seeking self motivated and passionate agents who have a desire to grow an agency and mentor other agents. What We Will Provide: ● Aggressive Compensation - Our agents start out at 100% rate of commission and have the opportunity to go upwards of 145%. ● Warm Clients - Access to our lead vendors FFL partners with, working with people who already asked for the insurance. No cold calling or prospecting. ● We focus on: cash value life insurance, mortgage protection, annuities, tax free retirement solutions, and Medicare Supplements. ● World Class Training - Access to unlimited free trainings from some of the top producers in the country. ● 3 Types of Income - Direct sale commissions, agency overrides, and renewal commissions. ● Top Carriers - We put our clients first by offering multiple options for coverage through several A rated top carriers. ● Mentorship - Direct mentoring from the top producers, not just in FFL but in the insurance industry as a whole, in how to grow your agency, run a business, and help other agents grow. Job Requirements: If you feel like you have what it takes to succeed at FFL and partner with us we urge you to apply. Requirements: ● Life Insurance Producers License. ● Willingness to learn from top Insurance Managers and mentor ● Exceptional Customer Service, Persistence, Self Discipline ● Set and meet individual goals for growth as a Top Performer ● Must be 18 years and older ● Must not have any bankruptcies or felonies ● Must be authorized to work in the USA Here is overview of the position: To apply please use this link to set up a phone interview TODAY -
01/24/2021
Full time
About Family First Life Family First Life prides itself on the respect, mentorship, and selfless leaders and agents working with us, starting from the top down with our President and CEO, Shawn Meaike. We are looking for Agents who have experience in the insurance industry that are looking to earn what they are worth and have unlimited potential to grow an agency along side us at FFL. The Agents we bring on board must be disciplined and willing to earn the average insurance agent's $122,000 + annual income, by following our structured training and lead program. Our mission at FFL is to make the families we protect and the families of our agents our number one priority. We can help our clients with Final Expense Insurance, Retirement Planning, Mortgage Protection, Medicare Supplements and more. To accomplish putting our clients first we work with multiple A rated insurance carriers to ensure we put our clients in the best possible protection. We give everything we have to earn trust and loyalty with our clients and our agents, starting with an aggressive commission structure so you can take care of your families as well as your clients. If you believe you have the drive, work ethic, experience, and ability to learn and be mentored to become a manager and business partner to grow with us, we are interested in getting to know you. We are seeking self motivated and passionate agents who have a desire to grow an agency and mentor other agents. What We Will Provide: ● Aggressive Compensation - Our agents start out at 100% rate of commission and have the opportunity to go upwards of 145%. ● Warm Clients - Access to our lead vendors FFL partners with, working with people who already asked for the insurance. No cold calling or prospecting. ● We focus on: cash value life insurance, mortgage protection, annuities, tax free retirement solutions, and Medicare Supplements. ● World Class Training - Access to unlimited free trainings from some of the top producers in the country. ● 3 Types of Income - Direct sale commissions, agency overrides, and renewal commissions. ● Top Carriers - We put our clients first by offering multiple options for coverage through several A rated top carriers. ● Mentorship - Direct mentoring from the top producers, not just in FFL but in the insurance industry as a whole, in how to grow your agency, run a business, and help other agents grow. Job Requirements: If you feel like you have what it takes to succeed at FFL and partner with us we urge you to apply. Requirements: ● Life Insurance Producers License. ● Willingness to learn from top Insurance Managers and mentor ● Exceptional Customer Service, Persistence, Self Discipline ● Set and meet individual goals for growth as a Top Performer ● Must be 18 years and older ● Must not have any bankruptcies or felonies ● Must be authorized to work in the USA Here is overview of the position: To apply please use this link to set up a phone interview TODAY -
Randstad
ADMINISTRATIVE ASSISTANT
Randstad Cambridge, Massachusetts
ADMINISTRATIVE ASSISTANT**job details:**+ location:Cambridge, MA+ salary:$19 - $20 per hour+ date posted:Thursday, January 14, 2021+ experience:Experienced+ job type:Temporary+ industry:Rail terminal services+ reference:AB_+ questions:**job description**ADMINISTRATIVE ASSISTANTRandstad is working with an education facility in the area to fill a position supporting a researcher who is well-known in their field. This position will require internet research, and tracking and organizing the data acquired. This person will be, at the direction of the professor and other research associates, gathering data via reputable sources and the internet, and tracking and recording it in an Excel spreadsheet. This role will require picking up equipment onsite, as well as the successful completion of a background check, but then will be done remotely for the duration. Requirements: -Tech savvy, proficient in the MS Office suite - Excel, and advanced in internet research -High attention to detail - ability to quickly and efficiently record data -Bachelor's Preferred -Experience with Research helpfulResponsibilities-Perform internet research, proactively searching topics on the internet and from reputable sources-Record all applicable information and data acquired-Utilize Excel for tracking, data entry, and data management-Review and edit correspondenceSkills+ Handling Confidential Information+ Google for Business Suite+ Google AdWords+ Preparing Agendas+ Problem Solving+ Organization+ Organizational SkillsEducation+ AssociatesQualifications+ Years of experience: 1 year+ Experience level:ExperiencedShift: FirstWorking hours: 8 AM - 5 PMRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
01/23/2021
Full time
ADMINISTRATIVE ASSISTANT**job details:**+ location:Cambridge, MA+ salary:$19 - $20 per hour+ date posted:Thursday, January 14, 2021+ experience:Experienced+ job type:Temporary+ industry:Rail terminal services+ reference:AB_+ questions:**job description**ADMINISTRATIVE ASSISTANTRandstad is working with an education facility in the area to fill a position supporting a researcher who is well-known in their field. This position will require internet research, and tracking and organizing the data acquired. This person will be, at the direction of the professor and other research associates, gathering data via reputable sources and the internet, and tracking and recording it in an Excel spreadsheet. This role will require picking up equipment onsite, as well as the successful completion of a background check, but then will be done remotely for the duration. Requirements: -Tech savvy, proficient in the MS Office suite - Excel, and advanced in internet research -High attention to detail - ability to quickly and efficiently record data -Bachelor's Preferred -Experience with Research helpfulResponsibilities-Perform internet research, proactively searching topics on the internet and from reputable sources-Record all applicable information and data acquired-Utilize Excel for tracking, data entry, and data management-Review and edit correspondenceSkills+ Handling Confidential Information+ Google for Business Suite+ Google AdWords+ Preparing Agendas+ Problem Solving+ Organization+ Organizational SkillsEducation+ AssociatesQualifications+ Years of experience: 1 year+ Experience level:ExperiencedShift: FirstWorking hours: 8 AM - 5 PMRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
Director, Global Regulatory Affairs, Oncology
Ipsen Biopharmaceuticals, Inc. Cambridge, Massachusetts
Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Overall Accountability 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. 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. Experience / Qualifications 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. Key Required Technical Competencies Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles. Ability to distil key information from complex and extensive sources and present the information in a constructive way. Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects. Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions. Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project. Proven capability to influence decision makers both internally and externally Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Proven ability to lead change and communicate difficult messages effectively. 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.","datePosted":"2020-12-08T00:00:00.000Z
01/23/2021
Full time
Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Overall Accountability 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. 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. Experience / Qualifications 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. Key Required Technical Competencies Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles. Ability to distil key information from complex and extensive sources and present the information in a constructive way. Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects. Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions. Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project. Proven capability to influence decision makers both internally and externally Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Proven ability to lead change and communicate difficult messages effectively. 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.","datePosted":"2020-12-08T00:00:00.000Z
Associate Scientist, AAV Process Development
Intellia Therapeutics Cambridge, Massachusetts
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: Intellia is seeking a skilled and motivated Associate Scientist to support AAV process development in the Technical Operations group. The ideal applicant will be experienced and capable in HEK suspension culture and transfection optimization for AAV production and AAV characterization assays. Experience with bioreactor suspension culture and scalable downstream processes under GMP is a plus. Team work, versatility, and strong problem solving/analytical skills are required. Responsibilities: AAV upstream process development and transfection optimization. Develop and perform pre-clinical scale up production processes based on QbD. Perform analytical methods for the evaluation of critical AAV product attributes. Collaborative integration within Tech Ops and with R&D and Automation groups. Develop SOPs and assist in technology transfers to CROs and strategic partners. Provide high quality data and ELN documentation to drive decision making in the CMC team. Communicate development results and production schedules with internal teams. Operate and maintain multiple laboratory instruments. Cell culture maintenance and analysis. Qualifications: Bachelors degree in Molecular Biology, Virology, or Biochemical Engineering with 5+ years of hands on industrial experience, or Masters degree with 2+ years of industry experience. Experience with HEK suspension AAV production and characterization. Proficiency with relevant cell culture, purification and analytical techniques. Experience in bioreactor cell culture and purification process development scale up for GMP production. Experience with assay development is a plus (e.g. CE-SDS, ddPCR, ELISA). Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions. Excellent verbal and written communication skills. 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.
01/23/2021
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: Intellia is seeking a skilled and motivated Associate Scientist to support AAV process development in the Technical Operations group. The ideal applicant will be experienced and capable in HEK suspension culture and transfection optimization for AAV production and AAV characterization assays. Experience with bioreactor suspension culture and scalable downstream processes under GMP is a plus. Team work, versatility, and strong problem solving/analytical skills are required. Responsibilities: AAV upstream process development and transfection optimization. Develop and perform pre-clinical scale up production processes based on QbD. Perform analytical methods for the evaluation of critical AAV product attributes. Collaborative integration within Tech Ops and with R&D and Automation groups. Develop SOPs and assist in technology transfers to CROs and strategic partners. Provide high quality data and ELN documentation to drive decision making in the CMC team. Communicate development results and production schedules with internal teams. Operate and maintain multiple laboratory instruments. Cell culture maintenance and analysis. Qualifications: Bachelors degree in Molecular Biology, Virology, or Biochemical Engineering with 5+ years of hands on industrial experience, or Masters degree with 2+ years of industry experience. Experience with HEK suspension AAV production and characterization. Proficiency with relevant cell culture, purification and analytical techniques. Experience in bioreactor cell culture and purification process development scale up for GMP production. Experience with assay development is a plus (e.g. CE-SDS, ddPCR, ELISA). Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions. Excellent verbal and written communication skills. 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.
Laboratory Associate
Alpha Consulting Cambridge, Massachusetts
LABORATORY ASSOCIATE CAMBRIDGE, MA Project Description: Looking for a highly motivated individual who will support an experienced chemical biology team. The candidate will carry out research on assigned research problems contributing to the attainment of a defined research objective. The problems assigned are normally short range in terms of time required for solution. The incumbent will be required to grow and maintain mammalian cell cultures and prepare reagents as required. Must be willing and able to work in multiple projects simultaneously. Required Skills: B.S., M.S., or PhD in Chemistry, Chemical biology, Biology, Immunology, Bioengineering or a related field is required. Previous laboratory research experience in an industry or academic setting is required (1-3 years minimum). Experience in mammalian cell culture, western blot, flow cytometry, and ELISAs are preferred. Highly motivated and willing to learn new science. Incumbent should be willing to work in a team setting or individually as required. Legally eligible to work onsite. Ability to work on different projects in parallel is required. The successful candidate should show a desire to learn and implement new methods and apply them to answer scientific questions. Ability to work in a team and interact with colleagues in a multidisciplinary environment is important. Open communication, an independent and precise way of working, and excellent team work skills are critical. Good communication skills are required. This 10+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Adriel: ALPHA'S REQUIREMENT #21-00202 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR
01/23/2021
Full time
LABORATORY ASSOCIATE CAMBRIDGE, MA Project Description: Looking for a highly motivated individual who will support an experienced chemical biology team. The candidate will carry out research on assigned research problems contributing to the attainment of a defined research objective. The problems assigned are normally short range in terms of time required for solution. The incumbent will be required to grow and maintain mammalian cell cultures and prepare reagents as required. Must be willing and able to work in multiple projects simultaneously. Required Skills: B.S., M.S., or PhD in Chemistry, Chemical biology, Biology, Immunology, Bioengineering or a related field is required. Previous laboratory research experience in an industry or academic setting is required (1-3 years minimum). Experience in mammalian cell culture, western blot, flow cytometry, and ELISAs are preferred. Highly motivated and willing to learn new science. Incumbent should be willing to work in a team setting or individually as required. Legally eligible to work onsite. Ability to work on different projects in parallel is required. The successful candidate should show a desire to learn and implement new methods and apply them to answer scientific questions. Ability to work in a team and interact with colleagues in a multidisciplinary environment is important. Open communication, an independent and precise way of working, and excellent team work skills are critical. Good communication skills are required. This 10+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Adriel: ALPHA'S REQUIREMENT #21-00202 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR
Robert Half
Contracts Administrator
Robert Half Cambridge, Massachusetts
Ref ID: 02675990 Classification: Contracts Administrator Compensation: DOE Are you looking to grow your legal career? This premier legal department has an opportunity for a highly skilled and motivated Contract Administrator. If you are a driven self-starter with a real passion for the legal industry, this may be the Contract Administrator position for you. Located in Cambridge, Massachusetts, this Contract Administrator job is full-time. Your responsibilities in this role - Put together contractual provisions and administering contract proposals - Manage and maintain contracts database - Look over contracts thoroughly to ensure completeness - Manage contract execution processes - Implement company contract execution policy and procedures - Expedite and follow the approval and execution process - Add contract details into company database - Guide the full life cycle of company contracts, from first request to final signature and contract distribution - Run reports from the contracts database as needed - Manage both internal and external requests for status of contracts - Negotiate terms of agreements Job Requirements: - Excellent written, verbal and social communication skills - Solid understanding of contracts, including but not limited to, NDAs, CTAs, MTAs, Consulting Agreements, CDAs etc. - Exceptional organizational skills to track and monitor contracts for future obligations, expiration dates and other contractual deadlines - Ability to thrive in a dynamic, high-pressure environment, to prioritize client matters and adapt to quick changes while remaining diligent through each task performed - Highly professional and able to use good judgment and maintain a high level of confidentiality and sensitivity - Mastery of diverse computer applications - 3+ years of experience in the specific field or related area - Eagerness to learn new concepts At this dynamic, growing firm, you can take the next step in your legal career! People who are eager to work in a strong team-oriented environment are our ideal candidates. . Robert Half Legal matches legal professionals and consultants with remote or on-site jobs on a full-time, project and temporary basis, serving both law firms and corporate legal departments. We also provide teams for complex projects, including litigation, eDiscovery, data privacy, and mergers and acquisitions. Our experienced staffing professionals can promote you to employers and advocate on your behalf. We provide access to top jobs, competitive compensation and benefits, and free online training. For more opportunities, get the Robert Half app and receive instant notifications when our AI matches your skills and experience with jobs. When you work with us, you're working with the best. Robert Half has been recognized as one of FORTUNE's "Most Admired Companies" every year since 1998 and was named to Forbes' inaugural list of America's Best Temporary Staffing Firms. Questions? Call your local office at 1.. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to temporary professionals. Visit for more information. © Robert Half Legal. An Equal Opportunity Employer. M/F/Disability/Veterans. Robert Half is not a law firm and does not provide legal representation. Robert Half project attorneys do not constitute a law firm among themselves. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use ( ).
01/23/2021
Full time
Ref ID: 02675990 Classification: Contracts Administrator Compensation: DOE Are you looking to grow your legal career? This premier legal department has an opportunity for a highly skilled and motivated Contract Administrator. If you are a driven self-starter with a real passion for the legal industry, this may be the Contract Administrator position for you. Located in Cambridge, Massachusetts, this Contract Administrator job is full-time. Your responsibilities in this role - Put together contractual provisions and administering contract proposals - Manage and maintain contracts database - Look over contracts thoroughly to ensure completeness - Manage contract execution processes - Implement company contract execution policy and procedures - Expedite and follow the approval and execution process - Add contract details into company database - Guide the full life cycle of company contracts, from first request to final signature and contract distribution - Run reports from the contracts database as needed - Manage both internal and external requests for status of contracts - Negotiate terms of agreements Job Requirements: - Excellent written, verbal and social communication skills - Solid understanding of contracts, including but not limited to, NDAs, CTAs, MTAs, Consulting Agreements, CDAs etc. - Exceptional organizational skills to track and monitor contracts for future obligations, expiration dates and other contractual deadlines - Ability to thrive in a dynamic, high-pressure environment, to prioritize client matters and adapt to quick changes while remaining diligent through each task performed - Highly professional and able to use good judgment and maintain a high level of confidentiality and sensitivity - Mastery of diverse computer applications - 3+ years of experience in the specific field or related area - Eagerness to learn new concepts At this dynamic, growing firm, you can take the next step in your legal career! People who are eager to work in a strong team-oriented environment are our ideal candidates. . Robert Half Legal matches legal professionals and consultants with remote or on-site jobs on a full-time, project and temporary basis, serving both law firms and corporate legal departments. We also provide teams for complex projects, including litigation, eDiscovery, data privacy, and mergers and acquisitions. Our experienced staffing professionals can promote you to employers and advocate on your behalf. We provide access to top jobs, competitive compensation and benefits, and free online training. For more opportunities, get the Robert Half app and receive instant notifications when our AI matches your skills and experience with jobs. When you work with us, you're working with the best. Robert Half has been recognized as one of FORTUNE's "Most Admired Companies" every year since 1998 and was named to Forbes' inaugural list of America's Best Temporary Staffing Firms. Questions? Call your local office at 1.. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to temporary professionals. Visit for more information. © Robert Half Legal. An Equal Opportunity Employer. M/F/Disability/Veterans. Robert Half is not a law firm and does not provide legal representation. Robert Half project attorneys do not constitute a law firm among themselves. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use ( ).
Scientist, Biology
Civetta Therapeutics Cambridge, Massachusetts
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 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 Scientist will be responsible for independently 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 Scientist must have excellent communication skills and be able to work with a positive attitude in a dynamic, fast-paced, cross-functional team environment focused on high quality science to propel us in delivering innovative cancer therapeutics. Responsibilities Key responsibilities Independently create, develop and validate quantitative cell-based assays to address mechanistic and functional needs for pipeline projects and platform Establish robust screening assays to support lead optimization programs Collaborate with colleagues in cross-functional project teams 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 Develop and continually advance one's knowledge base on the molecular pathways being targeted by our research projects Spend at least 75% of one's time at the bench Maintains laboratory notebook in a complete, consistent and concise manner in accordance with company policies and practices Future responsibilities may include supervision of other team members Qualifications Qualifications PhD in Molecular/Cellular Biology or Biochemistry, or related field with 0-2 years of postdoctoral research experience or BS/MS in Molecular/Cellular Biology or Biochemistry or related disciplines with 7+ years work experience in a biotech/pharma setting Strong understanding of cancer biology and signal pathways Extensive experience in mammalian cell culture; creating, developing and running cellular assays, and interrogating biological pathways using chemical biology tools Strongly preferred skills include cell line engineering using CRISPR to create knock-out or knock-in of our genes of interest, functional genomics screens, and biomarker discovery Experience with general molecular biological techniques including molecular cloning, 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
01/23/2021
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 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 Scientist will be responsible for independently 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 Scientist must have excellent communication skills and be able to work with a positive attitude in a dynamic, fast-paced, cross-functional team environment focused on high quality science to propel us in delivering innovative cancer therapeutics. Responsibilities Key responsibilities Independently create, develop and validate quantitative cell-based assays to address mechanistic and functional needs for pipeline projects and platform Establish robust screening assays to support lead optimization programs Collaborate with colleagues in cross-functional project teams 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 Develop and continually advance one's knowledge base on the molecular pathways being targeted by our research projects Spend at least 75% of one's time at the bench Maintains laboratory notebook in a complete, consistent and concise manner in accordance with company policies and practices Future responsibilities may include supervision of other team members Qualifications Qualifications PhD in Molecular/Cellular Biology or Biochemistry, or related field with 0-2 years of postdoctoral research experience or BS/MS in Molecular/Cellular Biology or Biochemistry or related disciplines with 7+ years work experience in a biotech/pharma setting Strong understanding of cancer biology and signal pathways Extensive experience in mammalian cell culture; creating, developing and running cellular assays, and interrogating biological pathways using chemical biology tools Strongly preferred skills include cell line engineering using CRISPR to create knock-out or knock-in of our genes of interest, functional genomics screens, and biomarker discovery Experience with general molecular biological techniques including molecular cloning, 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
Senior Research Associate - In Vitro Pharmacology
Sana Biotechnology Cambridge, Massachusetts
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 upon that vision. As a member of the In Vitro Pharmacology and Biomarker Discovery group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a Senior Research Associate to build essential platform capabilities as well as develop and implement functional assays to support biomarker discovery, IND enabling studies, platform and research programs. The Senior Research Associate will perform in vitro characterizations of lead gene and cell therapy candidates in complex pharmacological and clinically relevant models. He/She will have experience culturing a diverse array of primary cell types and experience establishing and phenotypically characterizing in vitro models of disease. The successful candidate will have demonstrated technical proficiency, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. DUTIES AND RESPONSIBILITIES Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways. Culture and maintain multiple primary cell types including but not limited to hepatocytes, T-cells, PBMC's, splenocytes, cardiomyocytes, as well as endothelial and stromal cell types. Establish and validate in vitro functional assays using a variety of platforms (high-content imaging, incucyte, flow cytometry, ELISA, MSD, Luminex, HTRF, qPCR) Responsible for thoughtful planning, coordination and execution of experiments. Makes detailed observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Proven ability to work independently. Presents results at team meetings. Facilitates discussion with other team members as necessary to ensure the completion of the team's projects. Comply with standard laboratory practices and company policies QUALIFICATIONS Basic Qualifications Master's degree or Bachelor's degree with 3-4+ years of laboratory experience in an academic or industry setting and proven proficiency performing independent research. Extensive hands-on experience culturing mammalian cell lines (primary and immortalized) with demonstrated competence in sterile cell culture technique and standard laboratory procedures. Experience developing and characterizing in vitro models of disease. Experience in the development of cell-based assays using a variety of platforms (Incucyte, High-content imaging, TR-FRET, ELISA, MSD, Flow Cytometry, Luminex, qPCR). Ability to proactively engage groups with diverse functions within a highly matrixed organization. Excellent oral and written communication skills, attention to detail and data quality, and experience working on cross-functional teams. Technical proficiency, scientific creativity, independent thought and ability to actively communicate with scientists throughout the organization. Preferred Qualifications Industry experience Experience with primary cell culture is highly preferred. Research experience in liver biology and/or immunology. Experience characterizing metabolic pathways and disease modeling
01/23/2021
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 upon that vision. As a member of the In Vitro Pharmacology and Biomarker Discovery group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a Senior Research Associate to build essential platform capabilities as well as develop and implement functional assays to support biomarker discovery, IND enabling studies, platform and research programs. The Senior Research Associate will perform in vitro characterizations of lead gene and cell therapy candidates in complex pharmacological and clinically relevant models. He/She will have experience culturing a diverse array of primary cell types and experience establishing and phenotypically characterizing in vitro models of disease. The successful candidate will have demonstrated technical proficiency, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. DUTIES AND RESPONSIBILITIES Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways. Culture and maintain multiple primary cell types including but not limited to hepatocytes, T-cells, PBMC's, splenocytes, cardiomyocytes, as well as endothelial and stromal cell types. Establish and validate in vitro functional assays using a variety of platforms (high-content imaging, incucyte, flow cytometry, ELISA, MSD, Luminex, HTRF, qPCR) Responsible for thoughtful planning, coordination and execution of experiments. Makes detailed observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Proven ability to work independently. Presents results at team meetings. Facilitates discussion with other team members as necessary to ensure the completion of the team's projects. Comply with standard laboratory practices and company policies QUALIFICATIONS Basic Qualifications Master's degree or Bachelor's degree with 3-4+ years of laboratory experience in an academic or industry setting and proven proficiency performing independent research. Extensive hands-on experience culturing mammalian cell lines (primary and immortalized) with demonstrated competence in sterile cell culture technique and standard laboratory procedures. Experience developing and characterizing in vitro models of disease. Experience in the development of cell-based assays using a variety of platforms (Incucyte, High-content imaging, TR-FRET, ELISA, MSD, Flow Cytometry, Luminex, qPCR). Ability to proactively engage groups with diverse functions within a highly matrixed organization. Excellent oral and written communication skills, attention to detail and data quality, and experience working on cross-functional teams. Technical proficiency, scientific creativity, independent thought and ability to actively communicate with scientists throughout the organization. Preferred Qualifications Industry experience Experience with primary cell culture is highly preferred. Research experience in liver biology and/or immunology. Experience characterizing metabolic pathways and disease modeling
Junior Property Manager - Life Science & Office
Michael Page Cambridge, Massachusetts
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Summary The Property Manager will directly report into the General Manager and oversee multiple properties within an office complex that entails and life science component. Client Details My client is a vertically integrated real estate developer specialized in life science. The company has established itself as one of the market leaders with multiple offices across the nation and through a successful value-add strategy. We are currently looking for an experienced Property Manager, with office experience and ideally exposure to life science. Description The Property Manager will directly report into the General Manager and have the following responsibilities: - Manage the daily operations of all properties including property maintenance. - Oversee repair and capital projects as well as coordinating with third party vendors. Work in close collaboration with the Director of Construction for ongoing projects. - Understand and assist in budget development for existing properties as well as utilize Yardi for additional property management activities. - Conduct staffing if required and build a strong team environment *if required remote or work with a skeleton crew on site. - Establish meaningful relations with the tenant and work closely with the Asset Management team on lease and contract negotiations. In addition, show a strong proficiency in lease compliance and building regulations. - Oversee facility cleaning regulations in regards to COVID 19 and work closely with the Maintenance team. Profile The ideal candidate for the Commercial Property Manager will have: - Bachelor degree in Business Administration, Real Estate or related - 4 + years experience in property management in commercial real estate (office) - Exposure to life science/lab properties preferred - Proficient in leasing, facility and maintenance oversight - Strong ability to create meaningful relationships with tenants - Ability to function in a boutique environment Job Offer In return, a successful candidate for the Property Manager will receive: - Competitive base salary - Bonus potential - Benefit package including health care, dental, vision - 401k - Boutique team environment Job Requirements: Property Management, financial reporting, Yardi
01/22/2021
Full time
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Summary The Property Manager will directly report into the General Manager and oversee multiple properties within an office complex that entails and life science component. Client Details My client is a vertically integrated real estate developer specialized in life science. The company has established itself as one of the market leaders with multiple offices across the nation and through a successful value-add strategy. We are currently looking for an experienced Property Manager, with office experience and ideally exposure to life science. Description The Property Manager will directly report into the General Manager and have the following responsibilities: - Manage the daily operations of all properties including property maintenance. - Oversee repair and capital projects as well as coordinating with third party vendors. Work in close collaboration with the Director of Construction for ongoing projects. - Understand and assist in budget development for existing properties as well as utilize Yardi for additional property management activities. - Conduct staffing if required and build a strong team environment *if required remote or work with a skeleton crew on site. - Establish meaningful relations with the tenant and work closely with the Asset Management team on lease and contract negotiations. In addition, show a strong proficiency in lease compliance and building regulations. - Oversee facility cleaning regulations in regards to COVID 19 and work closely with the Maintenance team. Profile The ideal candidate for the Commercial Property Manager will have: - Bachelor degree in Business Administration, Real Estate or related - 4 + years experience in property management in commercial real estate (office) - Exposure to life science/lab properties preferred - Proficient in leasing, facility and maintenance oversight - Strong ability to create meaningful relationships with tenants - Ability to function in a boutique environment Job Offer In return, a successful candidate for the Property Manager will receive: - Competitive base salary - Bonus potential - Benefit package including health care, dental, vision - 401k - Boutique team environment Job Requirements: Property Management, financial reporting, Yardi
Scientific Associate I - Formulation & Delivery
CSL Behring Cambridge, Massachusetts
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 This position is responsible for performance of mRNA vaccine and adjuvanted protein vaccine formulation and characterization, to support vaccine discovery and development. Responsibilities: Performance of mRNA vaccine biophysical characterization and stability evaluation to support vaccine process development. Performance of mRNA vaccine and adjuvanted protein vaccine formulation to support vaccine preclinical development in animal models. Write experimental protocols and prepare internal reports. Maintain lab notebooks. Collaborate with project teams, present research results and contribute to technical advancements and publications. Maintain functional laboratory equipment and follow HSE regulation. Qualifications: Bachelors degree and e xperience with lipid nanoparticle characterization eg DLS-Zeta measurement, MALS, HPLC is required. Experience with formulation assays eg. SDS-PAGE, Nanodrop, Osmolarity and Endotoxin testing is preferred. Experience with lipid nanoparticle formulation is preferred. T he ability to generate accurate and reproducible results along with multi-tasking and working effectively in a fast-paced environment are required. Ability to work in teams and written/oral communication skills are required.
01/22/2021
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 This position is responsible for performance of mRNA vaccine and adjuvanted protein vaccine formulation and characterization, to support vaccine discovery and development. Responsibilities: Performance of mRNA vaccine biophysical characterization and stability evaluation to support vaccine process development. Performance of mRNA vaccine and adjuvanted protein vaccine formulation to support vaccine preclinical development in animal models. Write experimental protocols and prepare internal reports. Maintain lab notebooks. Collaborate with project teams, present research results and contribute to technical advancements and publications. Maintain functional laboratory equipment and follow HSE regulation. Qualifications: Bachelors degree and e xperience with lipid nanoparticle characterization eg DLS-Zeta measurement, MALS, HPLC is required. Experience with formulation assays eg. SDS-PAGE, Nanodrop, Osmolarity and Endotoxin testing is preferred. Experience with lipid nanoparticle formulation is preferred. T he ability to generate accurate and reproducible results along with multi-tasking and working effectively in a fast-paced environment are required. Ability to work in teams and written/oral communication skills are required.
Senior Scientist, Proteomics
Civetta Therapeutics Cambridge, Massachusetts
Location: US-MA-Cambridge ID: 2 # of Openings : 1 Category: Research & Development Address: 10 Wilson Road Overview Civetta Therapeutics (Cambridge, MA) is recruiting a Scientist in Proteomics. Civetta is a cutting-edge biotechnology company, backed by Deerfield Management, and recently launched from the Broad Institute and Dana-Farber Cancer Institute (DFCI). Our founders, William Sellers (Broad/DFCI) and Eric Fischer (DFCI), world leaders in genomics and protein biology, launched Civetta with the mission to create a new precision medicine platform targeting "propeller" proteins. We are building a team of talented, dedicated scientists who share our vision and our passion to discover groundbreaking new drugs to treat some of the most difficult diseases, including cancer. If you are a talented life sciences professional who brings energy, passion, and scientific curiosity to the team, we welcome the opportunity to consider you for this important position in our growing company. The position. We are seeking a Senior Scientist to propel our Proteomics efforts, helping to build world-class platform capabilities in discovering and quantifying protein-protein and protein-small molecule interactions, supporting biological discovery and our drug development programs. Responsibilities Key Responsibilities Using internal and external (CRO) resources, build world class protein mass spectrometry (MS) capabilities to enable Civetta beta-propeller platform to: Discover and quantify propeller protein interactions and proximal proteins Quantify propeller interactions with small molecules Implement discovery proteomics and targeted single and multiplexed protein detection and quantification to enable target evaluation and discovery and compound selectivity profiling Enable covalent fragment discovery Help to specify and procure necessary equipment, enabling technologies and reagents Drive analysis and presentation of MS data Collaborate productively with cell biology and chemistry colleagues on design and execution of chemical biology experiments targeting beta-propeller proteins and multi-protein complexes Make intellectual contributions to all stages of drug discovery and project delivery Qualifications Qualifications Ph.D. degree in biochemistry, proteomics, chemical biology or related discipline with 5+ years of industry experience or Master's/Bachelor's degree with 10+ years of experience. Experience designing and implementing experiments to enable biological discovery using mass spectrometry and related tools. Proven ability to establish and optimize proteomic discovery platform. Experience balancing CRO and internal resources to solve problems and drive progress. Exceptional interpersonal and communication skills, and ability to effectively present data within the company and to other stakeholders. Adept at leading and working effectively within motivated cross-functional scientific teams to deliver project goals within timelines. 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. Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through Civetta Therapeutics' Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Civetta, and no fee/payment will be paid. Recruiters interested in working with Civetta Therapeutics can submit their information to , and we will contact you if needed. PM18 #LI-DNI
01/21/2021
Full time
Location: US-MA-Cambridge ID: 2 # of Openings : 1 Category: Research & Development Address: 10 Wilson Road Overview Civetta Therapeutics (Cambridge, MA) is recruiting a Scientist in Proteomics. Civetta is a cutting-edge biotechnology company, backed by Deerfield Management, and recently launched from the Broad Institute and Dana-Farber Cancer Institute (DFCI). Our founders, William Sellers (Broad/DFCI) and Eric Fischer (DFCI), world leaders in genomics and protein biology, launched Civetta with the mission to create a new precision medicine platform targeting "propeller" proteins. We are building a team of talented, dedicated scientists who share our vision and our passion to discover groundbreaking new drugs to treat some of the most difficult diseases, including cancer. If you are a talented life sciences professional who brings energy, passion, and scientific curiosity to the team, we welcome the opportunity to consider you for this important position in our growing company. The position. We are seeking a Senior Scientist to propel our Proteomics efforts, helping to build world-class platform capabilities in discovering and quantifying protein-protein and protein-small molecule interactions, supporting biological discovery and our drug development programs. Responsibilities Key Responsibilities Using internal and external (CRO) resources, build world class protein mass spectrometry (MS) capabilities to enable Civetta beta-propeller platform to: Discover and quantify propeller protein interactions and proximal proteins Quantify propeller interactions with small molecules Implement discovery proteomics and targeted single and multiplexed protein detection and quantification to enable target evaluation and discovery and compound selectivity profiling Enable covalent fragment discovery Help to specify and procure necessary equipment, enabling technologies and reagents Drive analysis and presentation of MS data Collaborate productively with cell biology and chemistry colleagues on design and execution of chemical biology experiments targeting beta-propeller proteins and multi-protein complexes Make intellectual contributions to all stages of drug discovery and project delivery Qualifications Qualifications Ph.D. degree in biochemistry, proteomics, chemical biology or related discipline with 5+ years of industry experience or Master's/Bachelor's degree with 10+ years of experience. Experience designing and implementing experiments to enable biological discovery using mass spectrometry and related tools. Proven ability to establish and optimize proteomic discovery platform. Experience balancing CRO and internal resources to solve problems and drive progress. Exceptional interpersonal and communication skills, and ability to effectively present data within the company and to other stakeholders. Adept at leading and working effectively within motivated cross-functional scientific teams to deliver project goals within timelines. 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. Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through Civetta Therapeutics' Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Civetta, and no fee/payment will be paid. Recruiters interested in working with Civetta Therapeutics can submit their information to , and we will contact you if needed. PM18 #LI-DNI
Senior Research Associate, Cellular Biology - Hematology
Cellarity Cambridge, Massachusetts
Company Summary: Cellarity, Inc. is a privately held, well-funded, early-stage biotechnology company that is pioneering a novel transformative therapeutic approach. Cellarity was founded by Flagship Pioneering, a team of entrepreneurial scientists that conceives, creates, resources, and grows first-in-category life sciences companies. Since 2000, Flagship has created over 75 groundbreaking companies that are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna Therapeutics (NASDAQ: MRNA), Seres Therapeutics (MCRB), Syros Pharmaceuticals (SYRS), Rubius Therapeutics (RUBY), Evelo Biosciences (EVLO), Kaleido Biosciences (KLDO), and Indigo Agriculture. Cellarity is a highly dynamic, entrepreneurial, and innovation-driven organization seeking to hire an exceptional scientist to join our team. Position Summary: Cellarity is seeking a talented and highly motivated Senior Research Associate with expertise in cellular biology to play a vital role in the company's efforts to validate novel target discovery approaches. You will be responsible for developing disease models using primary human hematopoietic cells to identify novel therapeutic interventions. The successful candidate will work closely with scientists of the Cellarity team to rapidly advance the scientific program. You should be comfortable working in and contributing to a very dynamic and cross-functional team environment. The ideal candidate must be independent, goal oriented, have excellent communication skills, be willing to learn new skills and work in a fast-paced entrepreneurial environment. Qualifications: Demonstrated excellence in tissue culture with primary cells Experience with human hematopoietic cells (CD34+, PBMCs) Proficiency with flow cytometry including designing and optimizing multi-parameter flow cytometry panels Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. B.Sc./M.Sc. in biology or related field, and minimum 2 years of relevant experience in bio-pharmaceutical industry. Key Responsibilities: Develop and conduct cell-based assays to model disease and test data-driven hypotheses. Generate datasets key for hypothesis generation Work both independently and as part of a collaborative team to execute and analyze experiments and present experimental findings at internal meetings. Maintain detailed records of experimental protocols and data in electronic laboratory notebook in accordance with company policy. Learn more about Cellarity at 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.
01/21/2021
Full time
Company Summary: Cellarity, Inc. is a privately held, well-funded, early-stage biotechnology company that is pioneering a novel transformative therapeutic approach. Cellarity was founded by Flagship Pioneering, a team of entrepreneurial scientists that conceives, creates, resources, and grows first-in-category life sciences companies. Since 2000, Flagship has created over 75 groundbreaking companies that are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna Therapeutics (NASDAQ: MRNA), Seres Therapeutics (MCRB), Syros Pharmaceuticals (SYRS), Rubius Therapeutics (RUBY), Evelo Biosciences (EVLO), Kaleido Biosciences (KLDO), and Indigo Agriculture. Cellarity is a highly dynamic, entrepreneurial, and innovation-driven organization seeking to hire an exceptional scientist to join our team. Position Summary: Cellarity is seeking a talented and highly motivated Senior Research Associate with expertise in cellular biology to play a vital role in the company's efforts to validate novel target discovery approaches. You will be responsible for developing disease models using primary human hematopoietic cells to identify novel therapeutic interventions. The successful candidate will work closely with scientists of the Cellarity team to rapidly advance the scientific program. You should be comfortable working in and contributing to a very dynamic and cross-functional team environment. The ideal candidate must be independent, goal oriented, have excellent communication skills, be willing to learn new skills and work in a fast-paced entrepreneurial environment. Qualifications: Demonstrated excellence in tissue culture with primary cells Experience with human hematopoietic cells (CD34+, PBMCs) Proficiency with flow cytometry including designing and optimizing multi-parameter flow cytometry panels Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. B.Sc./M.Sc. in biology or related field, and minimum 2 years of relevant experience in bio-pharmaceutical industry. Key Responsibilities: Develop and conduct cell-based assays to model disease and test data-driven hypotheses. Generate datasets key for hypothesis generation Work both independently and as part of a collaborative team to execute and analyze experiments and present experimental findings at internal meetings. Maintain detailed records of experimental protocols and data in electronic laboratory notebook in accordance with company policy. Learn more about Cellarity at 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.
Associate Director- IT Shared Services
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 Overall responsibility for the definition, delivery, implementation and operational success of IT Infrastructure and Shared Services portfolio. The scope includes but is not limited to; Service Desk and Desk Side operations, Network, Telephony, Identity Management, Work Stations, IT Security, SSO, MDM, etc. Incumbent will provide consultative support for a wide variety of projects with an IT component, including proprietary database(s) and analytics. Manage relationship with key vendors and overall budget responsibility for IT Shared Service portfolio. Responsibilities Lead the IT Shared Services and Infrastructure strategy, planning and operations. Develop and maintain a technology roadmap focused on improving and adding new services to enhance business and operational productivity. Clearly communicate business value, project statistics and issues to business sponsors. Ensure alignment of the service delivery strategy with the business strategy Be the primary Vendor Relationship Manager for key IT service providers, ensuring Service Levels are met. Work with business partners and vendors to establish a process for continuous improvement in service delivery, cost efficiency, contractual compliance. Ensure customer satisfaction by leading the collaborative development of service level agreements, delivery in line with the SLA's through ongoing monitoring. Review business practices on a regular basis assessing fit with current and potential IT Service providers, analyze business requirements by partnering with stakeholders across the organization to develop solutions for IT needs Lead IT projects, including the design and deployment of new IT systems and services. Function as a Subject Matter Expert on IT Infrastructure Services and Technology on a wide variety of projects, issues and strategies. Provide hands on support for employees on a wide variety of day to day needs Make recommendations for maturing and improving the IT Infrastructure and Shared Services portfolio. Help define IT infrastructure strategy, architecture, and processes. Maintain and create supporting documentation as needed. Assess vendors and develop test strategies for new hardware and software, maintaining GxP compliance where appropriate. Qualifications Client-focused individual with experience building up an IT Share Service function in a small fast-paced growing business environment. A collaborative management style and a strong customer service orientation. Firm grasp on IT infrastructure and operations best practices Excellent working knowledge in Vendor Management of IT Shared Services for the following areas: systems administration, service desk operations, network services, data storage systems, M365, etc. Experience leading and managing IT projects and rolling out IT infrastructures across various technologies Excellent project management skills and strong ability to prioritize. Strong critical thinking and decision-making skills, ability to be flexible in a fast-paced environment Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related field, or equivalent experience 3 - 6+ years of experience working in IT operations with demonstrated experience leading a hands on IT function in a small but, rapidly growing company 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.
01/21/2021
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 Overall responsibility for the definition, delivery, implementation and operational success of IT Infrastructure and Shared Services portfolio. The scope includes but is not limited to; Service Desk and Desk Side operations, Network, Telephony, Identity Management, Work Stations, IT Security, SSO, MDM, etc. Incumbent will provide consultative support for a wide variety of projects with an IT component, including proprietary database(s) and analytics. Manage relationship with key vendors and overall budget responsibility for IT Shared Service portfolio. Responsibilities Lead the IT Shared Services and Infrastructure strategy, planning and operations. Develop and maintain a technology roadmap focused on improving and adding new services to enhance business and operational productivity. Clearly communicate business value, project statistics and issues to business sponsors. Ensure alignment of the service delivery strategy with the business strategy Be the primary Vendor Relationship Manager for key IT service providers, ensuring Service Levels are met. Work with business partners and vendors to establish a process for continuous improvement in service delivery, cost efficiency, contractual compliance. Ensure customer satisfaction by leading the collaborative development of service level agreements, delivery in line with the SLA's through ongoing monitoring. Review business practices on a regular basis assessing fit with current and potential IT Service providers, analyze business requirements by partnering with stakeholders across the organization to develop solutions for IT needs Lead IT projects, including the design and deployment of new IT systems and services. Function as a Subject Matter Expert on IT Infrastructure Services and Technology on a wide variety of projects, issues and strategies. Provide hands on support for employees on a wide variety of day to day needs Make recommendations for maturing and improving the IT Infrastructure and Shared Services portfolio. Help define IT infrastructure strategy, architecture, and processes. Maintain and create supporting documentation as needed. Assess vendors and develop test strategies for new hardware and software, maintaining GxP compliance where appropriate. Qualifications Client-focused individual with experience building up an IT Share Service function in a small fast-paced growing business environment. A collaborative management style and a strong customer service orientation. Firm grasp on IT infrastructure and operations best practices Excellent working knowledge in Vendor Management of IT Shared Services for the following areas: systems administration, service desk operations, network services, data storage systems, M365, etc. Experience leading and managing IT projects and rolling out IT infrastructures across various technologies Excellent project management skills and strong ability to prioritize. Strong critical thinking and decision-making skills, ability to be flexible in a fast-paced environment Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related field, or equivalent experience 3 - 6+ years of experience working in IT operations with demonstrated experience leading a hands on IT function in a small but, rapidly growing company 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.
Manager, Investor Relations
Intellia Therapeutics Cambridge, Massachusetts
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: SUMMARY: This newly created role will join the Associate Director of Investor Relations in furthering Intellia's mission and strategy through the development and execution of its investor relations (IR) strategy. This person will have a unique opportunity to work closely with leadership across the organization and scientists at a leading clinical-stage genome editing company. The position is a very fast paced role with wide-ranging responsibilities from maintaining an active IR calendar to drafting strategic communications for the investment community. The ideal candidate is a self-starter, a team player and eager to learn. The Manager will report to the Associate Director, Investor Relations. RESPONSIBILITIES: Help drive an active IR calendar including the planning and execution of investor conferences, non-deal roadshows, bus tours and other investor events. Assist in preparing quarterly earnings materials, corporate deck updates, scientific presentations, and other external communications with an investor focus. Conduct ad hoc research projects to guide IR strategy and plans and keep current on competitive landscape. Monitor company-specific and industry-wide sell-side research including financial model updates. Serve as primary point of contact to corporate access teams to plan logistics for investor events. Prepare background information for key spokespeople in advance of investor meetings. Develop, maintain, and update corporate Q&A documents as needed. Actively manage the Customer Relationship Management (CRM) tool to track all IR interactions. Maintain and update the investor relations section of corporate website to reflect up-to-date information. Collaborate with key internal stakeholders (External Affairs & Communications, Finance, Legal, etc.) and assist in managing external agency and vendor relationships Support the preparation and execution of the Annual Shareholders' Meeting in close collaboration with the Finance and Legal team. Administrative responsibilities including scheduling of internal and external meetings and travel. QUALIFICATIONS: At least 2+ years of relevant work experience in an investor relation or communications position Biotech, pharmaceutical, medical device or tech company expertise a plus, given the high science nature of Intellia's business B.A. in Journalism, Communications (corporate or marketing focus), English or Biology/Chemistry degree with requisite communications work experience Excellent oral and written communication skills Strong client service focus and ability to work independently and in teams, as well as excellent organizational skills, flexibility, and ability to prioritize workflows Proactive and direct communication style Demonstrated ability to handle sensitive and confidential information with absolute discretion 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.
01/21/2021
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: SUMMARY: This newly created role will join the Associate Director of Investor Relations in furthering Intellia's mission and strategy through the development and execution of its investor relations (IR) strategy. This person will have a unique opportunity to work closely with leadership across the organization and scientists at a leading clinical-stage genome editing company. The position is a very fast paced role with wide-ranging responsibilities from maintaining an active IR calendar to drafting strategic communications for the investment community. The ideal candidate is a self-starter, a team player and eager to learn. The Manager will report to the Associate Director, Investor Relations. RESPONSIBILITIES: Help drive an active IR calendar including the planning and execution of investor conferences, non-deal roadshows, bus tours and other investor events. Assist in preparing quarterly earnings materials, corporate deck updates, scientific presentations, and other external communications with an investor focus. Conduct ad hoc research projects to guide IR strategy and plans and keep current on competitive landscape. Monitor company-specific and industry-wide sell-side research including financial model updates. Serve as primary point of contact to corporate access teams to plan logistics for investor events. Prepare background information for key spokespeople in advance of investor meetings. Develop, maintain, and update corporate Q&A documents as needed. Actively manage the Customer Relationship Management (CRM) tool to track all IR interactions. Maintain and update the investor relations section of corporate website to reflect up-to-date information. Collaborate with key internal stakeholders (External Affairs & Communications, Finance, Legal, etc.) and assist in managing external agency and vendor relationships Support the preparation and execution of the Annual Shareholders' Meeting in close collaboration with the Finance and Legal team. Administrative responsibilities including scheduling of internal and external meetings and travel. QUALIFICATIONS: At least 2+ years of relevant work experience in an investor relation or communications position Biotech, pharmaceutical, medical device or tech company expertise a plus, given the high science nature of Intellia's business B.A. in Journalism, Communications (corporate or marketing focus), English or Biology/Chemistry degree with requisite communications work experience Excellent oral and written communication skills Strong client service focus and ability to work independently and in teams, as well as excellent organizational skills, flexibility, and ability to prioritize workflows Proactive and direct communication style Demonstrated ability to handle sensitive and confidential information with absolute discretion 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.
Research Associate, Next Generation Sequencing (NGS)
Cellarity Cambridge, Massachusetts
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
01/21/2021
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
Strategic Account Manager - EMEA
Pacific Biosciences Cambridge, Massachusetts
Title: Strategic Account Manager - EMEA Based: UK / Cambridge Pacific Biosciences of California, Inc. (NASDAQ: PACB) is helping scientists forge a better understanding of biology by providing a unique long-read sequencing technology that generates more complete and accurate data, giving them more insights. Our sequencing systems allow scientists to characterize genomes, transcriptomes, and epigenomes from any organism. Scientists use our technology in areas such as human biomedical research, plant and animal sciences, and microbiology and infectious disease studies. Become part of the new paradigm in long-read sequencing and help shape the future of genomic study by joining the PacBio team. Key Responsibilities: Serve as the primary account manager for selected strategic accounts within the region Achieve sales targets and performance objectives within assigned accounts Demonstrate leadership and decision making in adjusting strategy to account for local factors, market shifts and/or client concerns. Create and execute account strategies over short (1 year) and long (3 year) timelines hitting critical milestones of performance objectives, revenue targets, and account growth metrics Drive orders through customer purchasing process and provide accurate sales forecasts Coordinate the involvement of Business Development, Product Marketing, Field Sales, and Field Application Scientists to drive opportunities and awareness in assigned accounts Act as a trusted PacBio advisor and establish professional, productive relationships with key personnel in assigned strategic accounts Establish global alignment by working collaboratively with counterparts in other regions, particularly in relation to global accounts Proactively assess, clarify, and validate customer needs on an ongoing basis Keep CRM system up to date and qualify leads from Marketing All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. Position Requirements: Significant and proven account management and sales experience in high end capital equipment and consumables is essential Minimum of 5 years successful direct sales experience into the Life Science and Clinical Research markets is required Clear understanding of the sales and purchasing processes in high value, multi-location accounts Track record of influencing key stakeholders and purchasing departments in a complex organizational matrix Strong understanding of scientific applications and technology developments as they relate to customer requirements as well as keeping fully up to date with competitor's offerings Ability to work at the highest level within customer organisations (Professors/CEO/CSO/CFO and other key influencers) Be of a competitive nature as well as a team player able to utilize support staff effectively Scientific or Technical degree is required with an advanced degree preferred Have the ability to work independently and be highly adaptable to change Acumen for public speaking and ability to deliver key presentations when required either independently or with technical support The role will be home based with a minimum of 60% travel required Home office to be located within proximity of a major airport Must be proficient in English, additional languages an advantage All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
01/20/2021
Full time
Title: Strategic Account Manager - EMEA Based: UK / Cambridge Pacific Biosciences of California, Inc. (NASDAQ: PACB) is helping scientists forge a better understanding of biology by providing a unique long-read sequencing technology that generates more complete and accurate data, giving them more insights. Our sequencing systems allow scientists to characterize genomes, transcriptomes, and epigenomes from any organism. Scientists use our technology in areas such as human biomedical research, plant and animal sciences, and microbiology and infectious disease studies. Become part of the new paradigm in long-read sequencing and help shape the future of genomic study by joining the PacBio team. Key Responsibilities: Serve as the primary account manager for selected strategic accounts within the region Achieve sales targets and performance objectives within assigned accounts Demonstrate leadership and decision making in adjusting strategy to account for local factors, market shifts and/or client concerns. Create and execute account strategies over short (1 year) and long (3 year) timelines hitting critical milestones of performance objectives, revenue targets, and account growth metrics Drive orders through customer purchasing process and provide accurate sales forecasts Coordinate the involvement of Business Development, Product Marketing, Field Sales, and Field Application Scientists to drive opportunities and awareness in assigned accounts Act as a trusted PacBio advisor and establish professional, productive relationships with key personnel in assigned strategic accounts Establish global alignment by working collaboratively with counterparts in other regions, particularly in relation to global accounts Proactively assess, clarify, and validate customer needs on an ongoing basis Keep CRM system up to date and qualify leads from Marketing All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. Position Requirements: Significant and proven account management and sales experience in high end capital equipment and consumables is essential Minimum of 5 years successful direct sales experience into the Life Science and Clinical Research markets is required Clear understanding of the sales and purchasing processes in high value, multi-location accounts Track record of influencing key stakeholders and purchasing departments in a complex organizational matrix Strong understanding of scientific applications and technology developments as they relate to customer requirements as well as keeping fully up to date with competitor's offerings Ability to work at the highest level within customer organisations (Professors/CEO/CSO/CFO and other key influencers) Be of a competitive nature as well as a team player able to utilize support staff effectively Scientific or Technical degree is required with an advanced degree preferred Have the ability to work independently and be highly adaptable to change Acumen for public speaking and ability to deliver key presentations when required either independently or with technical support The role will be home based with a minimum of 60% travel required Home office to be located within proximity of a major airport Must be proficient in English, additional languages an advantage All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
Senior Research Associate, In vivo Pharmacology
Cellarity Cambridge, Massachusetts
Company Summary: Cellarity, Inc. is a privately held, well-funded, early-stage biotechnology company that is pioneering a novel transformative therapeutic approach. Cellarity was founded by Flagship Pioneering, a team of entrepreneurial scientists that conceives, creates, resources, and grows first-in-category life sciences companies. Since 2000, Flagship has created over 75 groundbreaking companies that are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna Therapeutics (NASDAQ: MRNA), Seres Therapeutics (MCRB), Syros Pharmaceuticals (SYRS), Rubius Therapeutics (RUBY), Evelo Biosciences (EVLO), Kaleido Biosciences (KLDO), and Indigo Agriculture. Cellarity is a highly dynamic, entrepreneurial, and innovation-driven organization seeking to hire an exceptional scientist to join our team. Position Summary: Cellarity is seeking an energetic, talented and highly motivated Senior Research Associate to join our In Vivo Pharmacology efforts and play a vital role in the company's efforts to progress small molecule lead candidates to IND by performing robust in vivo pharmacology studies. The candidate will join a team of scientists and research associates responsible for internal and external in vivo studies in all program stages. The successful candidate will report to the Head of in vivo Pharmacology and work closely with the biology and technology program teams to rapidly advance Cellarity's platform and drug discovery programs. S/he will be comfortable working in and contributing to a highly dynamic, cross-functional and fast-paced entrepreneurial team environment. The ideal candidate must be independent, driven, open-minded, curious, goal-oriented and have excellent communication skills. Key Responsibilities: Contribute to study design, planning and performing in vivo experiments across a variety of disease models Work both independently and as part of a collaborative team to: execute in vivo studies internally and coordinate externally (CRO, academic lab) analyze in vivo experiments and present experimental findings at internal meetings perform various in vitro/ex vivo analyses in generated animal samples author study reports Maintain detailed records of experimental protocols and data in electronic laboratory notebook in accordance with company policy. Qualifications: Demonstrated experience in: multiple dosing routes in rodent species multiple blood collection methods in rodent species performing necropsies with tissue collection, preservation and processing in rodent species writing detailed study protocols Experience with various formulation preparation methods Proficiency with Immunoassays, qPCR or Nanostring, IHC and western blotting would be a plus Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. B.Sc./M.Sc. in biology or related field, and minimum 2 years of relevant experience in bio-pharmaceutical industry. 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.
01/20/2021
Full time
Company Summary: Cellarity, Inc. is a privately held, well-funded, early-stage biotechnology company that is pioneering a novel transformative therapeutic approach. Cellarity was founded by Flagship Pioneering, a team of entrepreneurial scientists that conceives, creates, resources, and grows first-in-category life sciences companies. Since 2000, Flagship has created over 75 groundbreaking companies that are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna Therapeutics (NASDAQ: MRNA), Seres Therapeutics (MCRB), Syros Pharmaceuticals (SYRS), Rubius Therapeutics (RUBY), Evelo Biosciences (EVLO), Kaleido Biosciences (KLDO), and Indigo Agriculture. Cellarity is a highly dynamic, entrepreneurial, and innovation-driven organization seeking to hire an exceptional scientist to join our team. Position Summary: Cellarity is seeking an energetic, talented and highly motivated Senior Research Associate to join our In Vivo Pharmacology efforts and play a vital role in the company's efforts to progress small molecule lead candidates to IND by performing robust in vivo pharmacology studies. The candidate will join a team of scientists and research associates responsible for internal and external in vivo studies in all program stages. The successful candidate will report to the Head of in vivo Pharmacology and work closely with the biology and technology program teams to rapidly advance Cellarity's platform and drug discovery programs. S/he will be comfortable working in and contributing to a highly dynamic, cross-functional and fast-paced entrepreneurial team environment. The ideal candidate must be independent, driven, open-minded, curious, goal-oriented and have excellent communication skills. Key Responsibilities: Contribute to study design, planning and performing in vivo experiments across a variety of disease models Work both independently and as part of a collaborative team to: execute in vivo studies internally and coordinate externally (CRO, academic lab) analyze in vivo experiments and present experimental findings at internal meetings perform various in vitro/ex vivo analyses in generated animal samples author study reports Maintain detailed records of experimental protocols and data in electronic laboratory notebook in accordance with company policy. Qualifications: Demonstrated experience in: multiple dosing routes in rodent species multiple blood collection methods in rodent species performing necropsies with tissue collection, preservation and processing in rodent species writing detailed study protocols Experience with various formulation preparation methods Proficiency with Immunoassays, qPCR or Nanostring, IHC and western blotting would be a plus Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. B.Sc./M.Sc. in biology or related field, and minimum 2 years of relevant experience in bio-pharmaceutical industry. 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.
Regulatory Affairs (Software Medical Device)
EXPERIS Cambridge, Massachusetts
Position Details: Job Title: Regulatory Affairs Specialist II Location: Cambridge, MA - 02139 Duration: 6+ months(with possible extension) Description: Regulatory Affairs Associate II Support the drafting of technical documentation, global core files, and HA submission section content across dossiers for priority projects within the Digital Health and Connected Medical Device portfolio Support drafting of software medical device regulatory procedures
01/20/2021
Full time
Position Details: Job Title: Regulatory Affairs Specialist II Location: Cambridge, MA - 02139 Duration: 6+ months(with possible extension) Description: Regulatory Affairs Associate II Support the drafting of technical documentation, global core files, and HA submission section content across dossiers for priority projects within the Digital Health and Connected Medical Device portfolio Support drafting of software medical device regulatory procedures
Antibody Engineering ~ Lead Scientist
Affinity Executive Search Cambridge, Massachusetts
My biotech client is expanding and looking to hire the leader for the Antibody Engineering group. The ideal candidate will take on the following tasks: * Conduct cutting-edge research to isolate and discover antibody-based candidate therapeutics * Discover and develop novel libraries for antibody drug discovery * Measure aggregation, solubility, stability and other parameters related to producing candidate antibody therapeutics * Produce purified candidate antibody therapeutics in quantities sufficient for animal studies The ideal candidate will possess the following qualities: * PhD in Molecular Biology or similar and 3+ years industry experience * A track record of driving therapeutic antibody and protein programs from early discovery into development stage * Experience with display-based technologies, flow cytometry and sorting, and protein biochemistry * Strong knowledge in antibody structural modeling, sequence prediction, and strong understanding of protein structure-function relationships * Exceptional communication skills and ability to work in a small + growing firm Salary and title are commensurate with experience. This is a Senior Scientist/Associate Director level role.
01/20/2021
Full time
My biotech client is expanding and looking to hire the leader for the Antibody Engineering group. The ideal candidate will take on the following tasks: * Conduct cutting-edge research to isolate and discover antibody-based candidate therapeutics * Discover and develop novel libraries for antibody drug discovery * Measure aggregation, solubility, stability and other parameters related to producing candidate antibody therapeutics * Produce purified candidate antibody therapeutics in quantities sufficient for animal studies The ideal candidate will possess the following qualities: * PhD in Molecular Biology or similar and 3+ years industry experience * A track record of driving therapeutic antibody and protein programs from early discovery into development stage * Experience with display-based technologies, flow cytometry and sorting, and protein biochemistry * Strong knowledge in antibody structural modeling, sequence prediction, and strong understanding of protein structure-function relationships * Exceptional communication skills and ability to work in a small + growing firm Salary and title are commensurate with experience. This is a Senior Scientist/Associate Director level role.
Yoh, A Day & Zimmermann Company
Contract Manufacturing Supplier Management Associate
Yoh, A Day & Zimmermann Company Cambridge, Massachusetts
Job Description: The contractor role is responsible for supporting client's Contract Manufacturing Organization (CMOs) management team in knowledge management and internal/external project governance activities. This position requires strong organizational and communication skills, with a key focus on transactional activities to support external manufacturing operations. Areas of focus will include: project management, support of clinical and commercial technology transfers, change management, and implementation of supplier selection tools for products within Client's pipeline. Extensive collaboration with internal customers in a matrix environment is required. The successful candidate will be a self-starter, eager to embrace a "learn by doing" approach and be willing to accept guidance from team members at all levels and disciplines across the organization. Responsibilities Support external manufacturing and development cross functional teams and key stakeholders for pharmaceutical products through clinical development, product validation and commercialization. Lead day-to-day transactional activities to support external manufacturing operations, including ownership of documentation and logistics supporting manufacturing readiness at external CMOs. Support key internal operations including inventory management through SAP and utilization of procure-to-pay systems such as GEP Drive knowledge management activities including documentation of meeting minutes and action items during internal alignment team meetings and tracking metrics from external drug product manufacturing activities Skills Understanding of supply chain, life sciences, or business/procurement, basics of GMP and Quality is desirable. Ability to complete assignments in an accurate, timely, and clearly documented manner with minimal oversight. Experience working within inventory management systems such as SAP is desired Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders. 0-2 experience in the field of manufacture of drug substance and parenteral drug products is required. Education A Bachelor's Degree in Life Sciences, Supply Chain, or Business is required Job Description: The contractor role is responsible for supporting client's Contract Manufacturing Organization (CMOs) management team in knowledge management and internal/external project governance activities. This position requires strong organizational and communication skills, with a key focus on transactional activities to support external manufacturing operations. Areas of focus will include: project management, support of clinical and commercial technology transfers, change management, and implementation of supplier selection tools for products within Client's pipeline. Extensive collaboration with internal customers in a matrix environment is required. The successful candidate will be a self-starter, eager to embrace a "learn by doing" approach and be willing to accept guidance from team members at all levels and disciplines across the organization. Responsibilities Support external manufacturing and development cross functional teams and key stakeholders for pharmaceutical products through clinical development, product validation and commercialization. Lead day-to-day transactional activities to support external manufacturing operations, including ownership of documentation and logistics supporting manufacturing readiness at external CMOs. Support key internal operations including inventory management through SAP and utilization of procure-to-pay systems such as GEP Drive knowledge management activities including documentation of meeting minutes and action items during internal alignment team meetings and tracking metrics from external drug product manufacturing activities Skills Understanding of supply chain, life sciences, or business/procurement, basics of GMP and Quality is desirable. Ability to complete assignments in an accurate, timely, and clearly documented manner with minimal oversight. Experience working within inventory management systems such as SAP is desired Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders. 0-2 experience in the field of manufacture of drug substance and parenteral drug products is required. Education A Bachelor's Degree in Life Sciences, Supply Chain, or Business is required Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. Category: Manufacturing , Keywords: Manufacturing Technician
01/20/2021
Full time
Job Description: The contractor role is responsible for supporting client's Contract Manufacturing Organization (CMOs) management team in knowledge management and internal/external project governance activities. This position requires strong organizational and communication skills, with a key focus on transactional activities to support external manufacturing operations. Areas of focus will include: project management, support of clinical and commercial technology transfers, change management, and implementation of supplier selection tools for products within Client's pipeline. Extensive collaboration with internal customers in a matrix environment is required. The successful candidate will be a self-starter, eager to embrace a "learn by doing" approach and be willing to accept guidance from team members at all levels and disciplines across the organization. Responsibilities Support external manufacturing and development cross functional teams and key stakeholders for pharmaceutical products through clinical development, product validation and commercialization. Lead day-to-day transactional activities to support external manufacturing operations, including ownership of documentation and logistics supporting manufacturing readiness at external CMOs. Support key internal operations including inventory management through SAP and utilization of procure-to-pay systems such as GEP Drive knowledge management activities including documentation of meeting minutes and action items during internal alignment team meetings and tracking metrics from external drug product manufacturing activities Skills Understanding of supply chain, life sciences, or business/procurement, basics of GMP and Quality is desirable. Ability to complete assignments in an accurate, timely, and clearly documented manner with minimal oversight. Experience working within inventory management systems such as SAP is desired Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders. 0-2 experience in the field of manufacture of drug substance and parenteral drug products is required. Education A Bachelor's Degree in Life Sciences, Supply Chain, or Business is required Job Description: The contractor role is responsible for supporting client's Contract Manufacturing Organization (CMOs) management team in knowledge management and internal/external project governance activities. This position requires strong organizational and communication skills, with a key focus on transactional activities to support external manufacturing operations. Areas of focus will include: project management, support of clinical and commercial technology transfers, change management, and implementation of supplier selection tools for products within Client's pipeline. Extensive collaboration with internal customers in a matrix environment is required. The successful candidate will be a self-starter, eager to embrace a "learn by doing" approach and be willing to accept guidance from team members at all levels and disciplines across the organization. Responsibilities Support external manufacturing and development cross functional teams and key stakeholders for pharmaceutical products through clinical development, product validation and commercialization. Lead day-to-day transactional activities to support external manufacturing operations, including ownership of documentation and logistics supporting manufacturing readiness at external CMOs. Support key internal operations including inventory management through SAP and utilization of procure-to-pay systems such as GEP Drive knowledge management activities including documentation of meeting minutes and action items during internal alignment team meetings and tracking metrics from external drug product manufacturing activities Skills Understanding of supply chain, life sciences, or business/procurement, basics of GMP and Quality is desirable. Ability to complete assignments in an accurate, timely, and clearly documented manner with minimal oversight. Experience working within inventory management systems such as SAP is desired Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders. 0-2 experience in the field of manufacture of drug substance and parenteral drug products is required. Education A Bachelor's Degree in Life Sciences, Supply Chain, or Business is required Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. Category: Manufacturing , Keywords: Manufacturing Technician
Manufacturing Supervisor-2nd and 3rd shift openings
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer multiple openings 2nd shift-M-F 3:00 PM-11:30 PM (15% differential) 3rd shift-Sun-11:00 PM-Fri 7:30 AM (20% differential) Purpose of the Position: Responsible for the implementation of production procedures and processes relating to Purification with the goal of optimizing the manufacturing process while meeting regulatory requirements. Assists development personnel in developing new, scalable processes and procedures which improve product yield and reduce manufacturing costs. Assists in the maintenance of equipment used. Key Job Responsibilities: Maintain a safe working environment and follow all site safety procedures. Assist in the development of new processes and procedures. Operate and perform routine maintenance on equipment used. Responsible for performing all work within Company and cGMP regulatory guidelines. Develop production procedures and processes to improve the product yield and reduce manufacturing costs of current processes. Evaluate data collected during process operations to verify validity and repeatability and find opportunities for improvement. Performs all levels of work required in the Department. Develop, Supervise and Train Staff assigned Job Knowledge Required: BS Degree in Chemistry or related and 5-8 years of industry relevant experience 3+ years of management experience Knowledge of chemical handling and basic lab safety required and experience in cGMP development setting preferred.
01/20/2021
Full time
Equal Opportunity Employer multiple openings 2nd shift-M-F 3:00 PM-11:30 PM (15% differential) 3rd shift-Sun-11:00 PM-Fri 7:30 AM (20% differential) Purpose of the Position: Responsible for the implementation of production procedures and processes relating to Purification with the goal of optimizing the manufacturing process while meeting regulatory requirements. Assists development personnel in developing new, scalable processes and procedures which improve product yield and reduce manufacturing costs. Assists in the maintenance of equipment used. Key Job Responsibilities: Maintain a safe working environment and follow all site safety procedures. Assist in the development of new processes and procedures. Operate and perform routine maintenance on equipment used. Responsible for performing all work within Company and cGMP regulatory guidelines. Develop production procedures and processes to improve the product yield and reduce manufacturing costs of current processes. Evaluate data collected during process operations to verify validity and repeatability and find opportunities for improvement. Performs all levels of work required in the Department. Develop, Supervise and Train Staff assigned Job Knowledge Required: BS Degree in Chemistry or related and 5-8 years of industry relevant experience 3+ years of management experience Knowledge of chemical handling and basic lab safety required and experience in cGMP development setting preferred.
Manufacturing Supervisor
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer multiple openings 2nd shift-M-F 3:00 PM-11:30 PM (15% differential) 3rd shift-Sun-11:00 PM-Fri 7:30 AM (20% differential) Purpose of the Position: Responsible for the implementation of production procedures and processes relating to Purification with the goal of optimizing the manufacturing process while meeting regulatory requirements. Assists development personnel in developing new, scalable processes and procedures which improve product yield and reduce manufacturing costs. Assists in the maintenance of equipment used. Key Job Responsibilities: Maintain a safe working environment and follow all site safety procedures. Assist in the development of new processes and procedures. Operate and perform routine maintenance on equipment used. Responsible for performing all work within Company and cGMP regulatory guidelines. Develop production procedures and processes to improve the product yield and reduce manufacturing costs of current processes. Evaluate data collected during process operations to verify validity and repeatability and find opportunities for improvement. Performs all levels of work required in the Department. Develop, Supervise and Train Staff assigned Job Knowledge Required: BS Degree in Chemistry or related and 5-8 years of industry relevant experience 3+ years of management experience Knowledge of chemical handling and basic lab safety required and experience in cGMP development setting preferred.
01/20/2021
Full time
Equal Opportunity Employer multiple openings 2nd shift-M-F 3:00 PM-11:30 PM (15% differential) 3rd shift-Sun-11:00 PM-Fri 7:30 AM (20% differential) Purpose of the Position: Responsible for the implementation of production procedures and processes relating to Purification with the goal of optimizing the manufacturing process while meeting regulatory requirements. Assists development personnel in developing new, scalable processes and procedures which improve product yield and reduce manufacturing costs. Assists in the maintenance of equipment used. Key Job Responsibilities: Maintain a safe working environment and follow all site safety procedures. Assist in the development of new processes and procedures. Operate and perform routine maintenance on equipment used. Responsible for performing all work within Company and cGMP regulatory guidelines. Develop production procedures and processes to improve the product yield and reduce manufacturing costs of current processes. Evaluate data collected during process operations to verify validity and repeatability and find opportunities for improvement. Performs all levels of work required in the Department. Develop, Supervise and Train Staff assigned Job Knowledge Required: BS Degree in Chemistry or related and 5-8 years of industry relevant experience 3+ years of management experience Knowledge of chemical handling and basic lab safety required and experience in cGMP development setting preferred.
Research Scientist
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer *Multiple Openings *Additional responsibilities will apply based on level Purpose of the Position: The Research Scientist-Level TBD is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides. Key Job Responsibilities: • Execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods • Analyze test samples, process data, and report results with minimal errors to support research and development primarily focused on oligonucleotides • Provide analytical support to Process Development and Manufacturing • Design and perform method development experiments • Perform GDP and technical peer review • Author technical documentation (e.g. methods, procedures) • Provide technical leadership in analytical project meetings • Maintain laboratory compliance • Provide basic-level training in lab techniques and procedures • Plan, track, and execute tasks to deliver project results on time • Communicate with clients and elevate issues to project team leader • Contribute to department objectives for continuous improvement and technical excellence • Contribute to a positive work atmosphere Job Knowledge Required: • BA/BS with 2-10+ yrs. of related experience • MS with 1-7+ yrs. of related experience • PhD with 4+ yrs. of related experience • Perform any laboratory procedure • Operate and troubleshoot KF, U/HPLC instruments • Knowledge of undergraduate general and organic chemistry • Analytical chemistry knowledge including theory and application of fundamental analytical techniques for identification, purity, and assay • Basic Word, Excel and PowerPoint required • Perform algebraic and basic statistical calculations correctly • Proficient in technical writing and department-wide presentations
01/20/2021
Full time
Equal Opportunity Employer *Multiple Openings *Additional responsibilities will apply based on level Purpose of the Position: The Research Scientist-Level TBD is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides. Key Job Responsibilities: • Execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods • Analyze test samples, process data, and report results with minimal errors to support research and development primarily focused on oligonucleotides • Provide analytical support to Process Development and Manufacturing • Design and perform method development experiments • Perform GDP and technical peer review • Author technical documentation (e.g. methods, procedures) • Provide technical leadership in analytical project meetings • Maintain laboratory compliance • Provide basic-level training in lab techniques and procedures • Plan, track, and execute tasks to deliver project results on time • Communicate with clients and elevate issues to project team leader • Contribute to department objectives for continuous improvement and technical excellence • Contribute to a positive work atmosphere Job Knowledge Required: • BA/BS with 2-10+ yrs. of related experience • MS with 1-7+ yrs. of related experience • PhD with 4+ yrs. of related experience • Perform any laboratory procedure • Operate and troubleshoot KF, U/HPLC instruments • Knowledge of undergraduate general and organic chemistry • Analytical chemistry knowledge including theory and application of fundamental analytical techniques for identification, purity, and assay • Basic Word, Excel and PowerPoint required • Perform algebraic and basic statistical calculations correctly • Proficient in technical writing and department-wide presentations
Analytical Development Research Scientist
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer *Multiple Openings *Additional responsibilities will apply based on level Purpose of the Position: The Research Scientist-Level TBD is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides. Key Job Responsibilities: • Execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods • Analyze test samples, process data, and report results with minimal errors to support research and development primarily focused on oligonucleotides • Provide analytical support to Process Development and Manufacturing • Design and perform method development experiments • Perform GDP and technical peer review • Author technical documentation (e.g. methods, procedures) • Provide technical leadership in analytical project meetings • Maintain laboratory compliance • Provide basic-level training in lab techniques and procedures • Plan, track, and execute tasks to deliver project results on time • Communicate with clients and elevate issues to project team leader • Contribute to department objectives for continuous improvement and technical excellence • Contribute to a positive work atmosphere Job Knowledge Required: • BA/BS with 2-10+ yrs. of related experience • MS with 1-7+ yrs. of related experience • PhD with 4+ yrs. of related experience • Perform any laboratory procedure • Operate and troubleshoot KF, U/HPLC instruments • Knowledge of undergraduate general and organic chemistry • Analytical chemistry knowledge including theory and application of fundamental analytical techniques for identification, purity, and assay • Basic Word, Excel and PowerPoint required • Perform algebraic and basic statistical calculations correctly • Proficient in technical writing and department-wide presentations
01/20/2021
Full time
Equal Opportunity Employer *Multiple Openings *Additional responsibilities will apply based on level Purpose of the Position: The Research Scientist-Level TBD is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides. Key Job Responsibilities: • Execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods • Analyze test samples, process data, and report results with minimal errors to support research and development primarily focused on oligonucleotides • Provide analytical support to Process Development and Manufacturing • Design and perform method development experiments • Perform GDP and technical peer review • Author technical documentation (e.g. methods, procedures) • Provide technical leadership in analytical project meetings • Maintain laboratory compliance • Provide basic-level training in lab techniques and procedures • Plan, track, and execute tasks to deliver project results on time • Communicate with clients and elevate issues to project team leader • Contribute to department objectives for continuous improvement and technical excellence • Contribute to a positive work atmosphere Job Knowledge Required: • BA/BS with 2-10+ yrs. of related experience • MS with 1-7+ yrs. of related experience • PhD with 4+ yrs. of related experience • Perform any laboratory procedure • Operate and troubleshoot KF, U/HPLC instruments • Knowledge of undergraduate general and organic chemistry • Analytical chemistry knowledge including theory and application of fundamental analytical techniques for identification, purity, and assay • Basic Word, Excel and PowerPoint required • Perform algebraic and basic statistical calculations correctly • Proficient in technical writing and department-wide presentations
Manufacturing Associate
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer Available openings on each shift-* all Manufacturing Chemist I levels will need to be temporary to hire 1st shift- M-F, 7:00-3:30 2nd shift-M-F 3:00pm-11:30pm (15% shift differential) 3rd shift Sun night-11:00pm-Friday morning at 7:30am (20% shift differential) Rotating Shift- 36/48 schedule (5% shift differential) Why Join Avecia? Interested in working for the world leader in oligonucleotide manufacturing? Avecia is at the forefront of therapeutic technologies and we are rapidly growing! Come work for Avecia and make a difference in personalized medicine. We are a multi-site, multi-billion dollar organization with a strong, stable business pipeline. Avecia strives to promote employees and offer career advancement opportunities to keep employees engaged and challenged! Purpose of Position: • Responsible for the implementation of assigned production procedures working within defined production schedules. • Responsible for performing all work within company and cGMP regulatory compliance. • Maintaining a safe work environment and following all site safety procedure. • Participation as a member of a safety team. • Performs routine, generally highly structure work. • Responsible for staying current with the prescribed training curriculum specified for the job title. Key Responsibilities: • Execute defined lab start up and shutdown procedures. • Maintaining a clean and organized work environment in accordance with defined procedures. • Qualify and maintain Qualification on all assigned manufacturing processes which may include: • Synthesis and/or purification equipment cleaning and setup. • General solution preparation and column packing • Lab cleaning, changeover, start up and shut down procedures • Routine equipment monitoring, chart recorders and spectrophotometers. • Monitor automated systems and record operational data. • Perform general routine operations including: pH measurements, UV determinations, Fraction collection Job Knowledge Required: • High School diploma or equivalent work experience • Biotechnology certificate or college degree is strongly preferred.
01/20/2021
Full time
Equal Opportunity Employer Available openings on each shift-* all Manufacturing Chemist I levels will need to be temporary to hire 1st shift- M-F, 7:00-3:30 2nd shift-M-F 3:00pm-11:30pm (15% shift differential) 3rd shift Sun night-11:00pm-Friday morning at 7:30am (20% shift differential) Rotating Shift- 36/48 schedule (5% shift differential) Why Join Avecia? Interested in working for the world leader in oligonucleotide manufacturing? Avecia is at the forefront of therapeutic technologies and we are rapidly growing! Come work for Avecia and make a difference in personalized medicine. We are a multi-site, multi-billion dollar organization with a strong, stable business pipeline. Avecia strives to promote employees and offer career advancement opportunities to keep employees engaged and challenged! Purpose of Position: • Responsible for the implementation of assigned production procedures working within defined production schedules. • Responsible for performing all work within company and cGMP regulatory compliance. • Maintaining a safe work environment and following all site safety procedure. • Participation as a member of a safety team. • Performs routine, generally highly structure work. • Responsible for staying current with the prescribed training curriculum specified for the job title. Key Responsibilities: • Execute defined lab start up and shutdown procedures. • Maintaining a clean and organized work environment in accordance with defined procedures. • Qualify and maintain Qualification on all assigned manufacturing processes which may include: • Synthesis and/or purification equipment cleaning and setup. • General solution preparation and column packing • Lab cleaning, changeover, start up and shut down procedures • Routine equipment monitoring, chart recorders and spectrophotometers. • Monitor automated systems and record operational data. • Perform general routine operations including: pH measurements, UV determinations, Fraction collection Job Knowledge Required: • High School diploma or equivalent work experience • Biotechnology certificate or college degree is strongly preferred.
Director, Onivyde Marketing
Ipsen Biopharmaceuticals, Inc. Cambridge, Massachusetts
Title: Director, Onivyde Marketing Company: Ipsen Biopharmaceuticals Inc. Job Description: ONIVYDE (irinotecan liposome injection) is proven to help people with metastatic Pancreatic Cancer, who previously received gemcitabine chemotherapy, live longer when given in combination with 2 other medicines, fluorouracil (known as "5-FU") and leucovorin (known as "LV"). Onivyde represents a significant proportion of the Ipsen North America revenues and is a critical asset to the Oncology Business Unit. Considerable additionally opportunity exists to grow share in the post-gemcitabine Pancreatic Cancer setting and the brand is expected to drive continued revenue growth in the coming years. Onivyde also accounts for one of the largest lifecycle investments at Ipsen with potential additional indications providing the opportunity to serve significantly more patients with rare cancers. The Marketing Director, Onivyde US Marketing is a key leadership role on the Onivyde Brand Team. The position will report to the Vice President, Onivyde Commercial and will be a member of the Onivyde US Leadership Team. The successful candidate will lead all US promotional activities to help the brand achieve short-term and long-term revenue goals, provide leadership to the promotional team and play a key role on the cross-functional brand team. Responsibilities include managing all engagements with creative agencies, developing personal and multi-channel HCP and DTP promotional plans, leading execution of these plans and maintaining overall leadership of the marketing budget. Additionally, the director also provides leadership in the development of annual strategic and operational plans. This role will have responsibility for managing direct reports. In addition to leading marketing for the inline post-gemcitabine indication in Pancreatic Cancer, the director will lead the development of promotional launch plans for an exciting potential upcoming indication for Onivyde. Responsibility will include building comprehensive personal and multi-channel marketing plans for execution upon FDA approval Leadership skills and proven track record of building and executing marketing plans will be critical in this role. Providing marketing direction as well as leading the cross functional Brand Team and providing clear guidance to achieve a best in class performance is imperative. Additionally, this position will hire the Onivyde Marketing team and be responsible for the acquisition and development of top Oncology Marketing talent to achieve key milestones and business objectives. Responsibilities Responsibilities will include, but are not limited to, the following: Develop a high-performing marketing team by hiring, retaining and coaching team members and driving a high level of engagement and innovation Provide strategic leadership by focusing on clear and relevant brand strategic imperatives aligned with the market opportunity and brand positioning Drive engaging creative campaigns, messaging, targeting, segmentation, for inline indication and create effective plans for lifecycle indications for execution upon FDA approval Lead HCP and DTP marketing on the brand team and empower direct reports and cross-functional colleagues to deliver best in class marketing initiatives Support the extended brand team in developing, maintaining and regularly reporting on KPI metrics to help monitor execution of brand priorities Establish relationships with agency partners and drive accountability for high quality work, on time and within budget Support strong brand relationships with Patient Advocacy organizations and KOLs Build upon the ONIVYDE team culture of high performance, innovation, collaboration and accountability within the marketing team and help drive these values across the cross-functional team Develop close collaborative relationship the cross-functional brand team; work closely with Value & Access, Digital Customer Interaction team and the Insights team to drive brand performance Manage overall Onivyde marketing budget and ensure resources are utilized to deliver maximum ROI Role model the One Ipsen Way of Being and embed values and support an environment of engagement and inclusion in the brand team Demonstrate high ethical and professional standards with all business contacts +/- 25% Domestic and International will be required Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff Education Bachelor's Degree or Equivalent, MBA preferred Experience Biopharma commercial experience; minimum 8 years of pharmaceutical or biotechnology sales, marketing, creative agency or consulting experience, with at least 5 of those years in marketing Strong ability to lead direct reports and effectively influence cross-functional teams Track record of business performance and analytical problem solving Strong communication and presentation skills at all levels; Ability to communicate brand priorities and performance to leadership and translate promotional plans to cross-functional teams and sales force Ability to operate in a highly matrixed and collaborative cross-functional environment Strong pharmaceutical marketing skills in HCP, DTP, personal and multichannel promotions; Oncology marketing experience preferred Demonstrated marketing competencies including insight generation, segmentation, positioning, campaign development and tactical planning and execution 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.","datePosted":"2020-12-20T00:00:00.000Z
01/20/2021
Full time
Title: Director, Onivyde Marketing Company: Ipsen Biopharmaceuticals Inc. Job Description: ONIVYDE (irinotecan liposome injection) is proven to help people with metastatic Pancreatic Cancer, who previously received gemcitabine chemotherapy, live longer when given in combination with 2 other medicines, fluorouracil (known as "5-FU") and leucovorin (known as "LV"). Onivyde represents a significant proportion of the Ipsen North America revenues and is a critical asset to the Oncology Business Unit. Considerable additionally opportunity exists to grow share in the post-gemcitabine Pancreatic Cancer setting and the brand is expected to drive continued revenue growth in the coming years. Onivyde also accounts for one of the largest lifecycle investments at Ipsen with potential additional indications providing the opportunity to serve significantly more patients with rare cancers. The Marketing Director, Onivyde US Marketing is a key leadership role on the Onivyde Brand Team. The position will report to the Vice President, Onivyde Commercial and will be a member of the Onivyde US Leadership Team. The successful candidate will lead all US promotional activities to help the brand achieve short-term and long-term revenue goals, provide leadership to the promotional team and play a key role on the cross-functional brand team. Responsibilities include managing all engagements with creative agencies, developing personal and multi-channel HCP and DTP promotional plans, leading execution of these plans and maintaining overall leadership of the marketing budget. Additionally, the director also provides leadership in the development of annual strategic and operational plans. This role will have responsibility for managing direct reports. In addition to leading marketing for the inline post-gemcitabine indication in Pancreatic Cancer, the director will lead the development of promotional launch plans for an exciting potential upcoming indication for Onivyde. Responsibility will include building comprehensive personal and multi-channel marketing plans for execution upon FDA approval Leadership skills and proven track record of building and executing marketing plans will be critical in this role. Providing marketing direction as well as leading the cross functional Brand Team and providing clear guidance to achieve a best in class performance is imperative. Additionally, this position will hire the Onivyde Marketing team and be responsible for the acquisition and development of top Oncology Marketing talent to achieve key milestones and business objectives. Responsibilities Responsibilities will include, but are not limited to, the following: Develop a high-performing marketing team by hiring, retaining and coaching team members and driving a high level of engagement and innovation Provide strategic leadership by focusing on clear and relevant brand strategic imperatives aligned with the market opportunity and brand positioning Drive engaging creative campaigns, messaging, targeting, segmentation, for inline indication and create effective plans for lifecycle indications for execution upon FDA approval Lead HCP and DTP marketing on the brand team and empower direct reports and cross-functional colleagues to deliver best in class marketing initiatives Support the extended brand team in developing, maintaining and regularly reporting on KPI metrics to help monitor execution of brand priorities Establish relationships with agency partners and drive accountability for high quality work, on time and within budget Support strong brand relationships with Patient Advocacy organizations and KOLs Build upon the ONIVYDE team culture of high performance, innovation, collaboration and accountability within the marketing team and help drive these values across the cross-functional team Develop close collaborative relationship the cross-functional brand team; work closely with Value & Access, Digital Customer Interaction team and the Insights team to drive brand performance Manage overall Onivyde marketing budget and ensure resources are utilized to deliver maximum ROI Role model the One Ipsen Way of Being and embed values and support an environment of engagement and inclusion in the brand team Demonstrate high ethical and professional standards with all business contacts +/- 25% Domestic and International will be required Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff Education Bachelor's Degree or Equivalent, MBA preferred Experience Biopharma commercial experience; minimum 8 years of pharmaceutical or biotechnology sales, marketing, creative agency or consulting experience, with at least 5 of those years in marketing Strong ability to lead direct reports and effectively influence cross-functional teams Track record of business performance and analytical problem solving Strong communication and presentation skills at all levels; Ability to communicate brand priorities and performance to leadership and translate promotional plans to cross-functional teams and sales force Ability to operate in a highly matrixed and collaborative cross-functional environment Strong pharmaceutical marketing skills in HCP, DTP, personal and multichannel promotions; Oncology marketing experience preferred Demonstrated marketing competencies including insight generation, segmentation, positioning, campaign development and tactical planning and execution 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.","datePosted":"2020-12-20T00:00:00.000Z
Manufacturing Associate-Level TBD
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer Available openings on each shift-* all Manufacturing Chemist I levels will need to be temporary to hire 1st shift- M-F, 7:00-3:30 2nd shift-M-F 3:00pm-11:30pm (15% shift differential) 3rd shift Sun night-11:00pm-Friday morning at 7:30am (20% shift differential) Rotating Shift- 36/48 schedule (5% shift differential) Why Join Avecia? Interested in working for the world leader in oligonucleotide manufacturing? Avecia is at the forefront of therapeutic technologies and we are rapidly growing! Come work for Avecia and make a difference in personalized medicine. We are a multi-site, multi-billion dollar organization with a strong, stable business pipeline. Avecia strives to promote employees and offer career advancement opportunities to keep employees engaged and challenged! Purpose of Position: • Responsible for the implementation of assigned production procedures working within defined production schedules. • Responsible for performing all work within company and cGMP regulatory compliance. • Maintaining a safe work environment and following all site safety procedure. • Participation as a member of a safety team. • Performs routine, generally highly structure work. • Responsible for staying current with the prescribed training curriculum specified for the job title. Key Responsibilities: • Execute defined lab start up and shutdown procedures. • Maintaining a clean and organized work environment in accordance with defined procedures. • Qualify and maintain Qualification on all assigned manufacturing processes which may include: • Synthesis and/or purification equipment cleaning and setup. • General solution preparation and column packing • Lab cleaning, changeover, start up and shut down procedures • Routine equipment monitoring, chart recorders and spectrophotometers. • Monitor automated systems and record operational data. • Perform general routine operations including: pH measurements, UV determinations, Fraction collection Job Knowledge Required: • High School diploma or equivalent work experience • Biotechnology certificate or college degree is strongly preferred.
01/20/2021
Full time
Equal Opportunity Employer Available openings on each shift-* all Manufacturing Chemist I levels will need to be temporary to hire 1st shift- M-F, 7:00-3:30 2nd shift-M-F 3:00pm-11:30pm (15% shift differential) 3rd shift Sun night-11:00pm-Friday morning at 7:30am (20% shift differential) Rotating Shift- 36/48 schedule (5% shift differential) Why Join Avecia? Interested in working for the world leader in oligonucleotide manufacturing? Avecia is at the forefront of therapeutic technologies and we are rapidly growing! Come work for Avecia and make a difference in personalized medicine. We are a multi-site, multi-billion dollar organization with a strong, stable business pipeline. Avecia strives to promote employees and offer career advancement opportunities to keep employees engaged and challenged! Purpose of Position: • Responsible for the implementation of assigned production procedures working within defined production schedules. • Responsible for performing all work within company and cGMP regulatory compliance. • Maintaining a safe work environment and following all site safety procedure. • Participation as a member of a safety team. • Performs routine, generally highly structure work. • Responsible for staying current with the prescribed training curriculum specified for the job title. Key Responsibilities: • Execute defined lab start up and shutdown procedures. • Maintaining a clean and organized work environment in accordance with defined procedures. • Qualify and maintain Qualification on all assigned manufacturing processes which may include: • Synthesis and/or purification equipment cleaning and setup. • General solution preparation and column packing • Lab cleaning, changeover, start up and shut down procedures • Routine equipment monitoring, chart recorders and spectrophotometers. • Monitor automated systems and record operational data. • Perform general routine operations including: pH measurements, UV determinations, Fraction collection Job Knowledge Required: • High School diploma or equivalent work experience • Biotechnology certificate or college degree is strongly preferred.
AD Research Scientist-Level TBD
Nitto Denko Avecia Cambridge, Massachusetts
Equal Opportunity Employer *Multiple Openings *Additional responsibilities will apply based on level Purpose of the Position: The Research Scientist-Level TBD is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides. Key Job Responsibilities: • Execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods • Analyze test samples, process data, and report results with minimal errors to support research and development primarily focused on oligonucleotides • Provide analytical support to Process Development and Manufacturing • Design and perform method development experiments • Perform GDP and technical peer review • Author technical documentation (e.g. methods, procedures) • Provide technical leadership in analytical project meetings • Maintain laboratory compliance • Provide basic-level training in lab techniques and procedures • Plan, track, and execute tasks to deliver project results on time • Communicate with clients and elevate issues to project team leader • Contribute to department objectives for continuous improvement and technical excellence • Contribute to a positive work atmosphere Job Knowledge Required: • BA/BS with 2-10+ yrs. of related experience • MS with 1-7+ yrs. of related experience • PhD with 4+ yrs. of related experience • Perform any laboratory procedure • Operate and troubleshoot KF, U/HPLC instruments • Knowledge of undergraduate general and organic chemistry • Analytical chemistry knowledge including theory and application of fundamental analytical techniques for identification, purity, and assay • Basic Word, Excel and PowerPoint required • Perform algebraic and basic statistical calculations correctly • Proficient in technical writing and department-wide presentations
01/20/2021
Full time
Equal Opportunity Employer *Multiple Openings *Additional responsibilities will apply based on level Purpose of the Position: The Research Scientist-Level TBD is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides. Key Job Responsibilities: • Execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods • Analyze test samples, process data, and report results with minimal errors to support research and development primarily focused on oligonucleotides • Provide analytical support to Process Development and Manufacturing • Design and perform method development experiments • Perform GDP and technical peer review • Author technical documentation (e.g. methods, procedures) • Provide technical leadership in analytical project meetings • Maintain laboratory compliance • Provide basic-level training in lab techniques and procedures • Plan, track, and execute tasks to deliver project results on time • Communicate with clients and elevate issues to project team leader • Contribute to department objectives for continuous improvement and technical excellence • Contribute to a positive work atmosphere Job Knowledge Required: • BA/BS with 2-10+ yrs. of related experience • MS with 1-7+ yrs. of related experience • PhD with 4+ yrs. of related experience • Perform any laboratory procedure • Operate and troubleshoot KF, U/HPLC instruments • Knowledge of undergraduate general and organic chemistry • Analytical chemistry knowledge including theory and application of fundamental analytical techniques for identification, purity, and assay • Basic Word, Excel and PowerPoint required • Perform algebraic and basic statistical calculations correctly • Proficient in technical writing and department-wide presentations
Yoh, A Day & Zimmermann Company
Government Team Lead, Procurement
Yoh, A Day & Zimmermann Company Cambridge, Massachusetts
This position serves as an integral member of the Contracts, Subcontracts, Procurement & Property (CSPP) department. CSPP strives to provide both its internal and external customers with solution-oriented leadership and guidance and is focused on achieving the strategic objectives of the organization while balancing risk and regulatory compliance. The ideal candidate has an interest in contributing to the success of the entire CSPP department in a fast-paced, multifaceted environment. Reporting to the Associate Director of Procurement and Property, the Government Procurement Lead is responsible to provide supervision and oversight of two Senior Government Buyers along with the execution of all supply chain/purchasing responsibilities for an individual program area. The applicant is responsible for establishing priorities, leading daily activities and ensuring the timely and proper execution for the procurement of all Federal funded purchases in accordance with State/Local and U.S. Government (FAR/DFARS) procurement policies, procedures and regulations. Applicant should have a keen interest in business/contract law and supply chain management and must demonstrate judgement to interpret internal and external issues, develop best practices and provide recommendations to senior CSPP staff. Responsible for training, planning, coordinating, reviewing and approves the work of direct reports involved with the Government procurement process on a daily basis. Applicant will serve as acquisition expert to the Government procurement team purchasing a variety of goods and services to include, but not limited to, construction, information technology, engineering/professional services, material/supplies and more. Serve as the direct link between procurement and the program offices to lead the coordination of supply Chain bid/proposal activities, provide risk management strategies, prepare and execute the PO packages for defined program area. Work closely with the Associate Director of Procurement and Procurement peers to share best practices and continuously identify process improvement opportunities for effective tracking of procurement activities. Work Closely with the Vendor Management Lead in identifying spend patterns, defining the category and commodities to develop the best strategic partnerships and optimize value for the program offices. Collaborate with other functional areas of CSPP, Finance and Administration, Legal and Corporate and promote cooperation and commitment within the team to achieve goals and objectives. Support other special projects and/or represents the department on cross-functional teams as assigned by the Associate Director of Procurement and Property. As directed, supports the development of CSPP department-wide policies and procedures. Provide training and direction to subordinates based on departmental policies, purchasing/contractual terms, FAR/DFARS requirements, compliance issues and system requirements. Negotiates purchase orders including price/cost and coordinates negotiations of terms and conditions with the internal legal team and CSPP leadership if necessary. Identify risk in terms and conditions that deviate from company policy. Support senior CSPP staff in developing and presenting risk mitigation approaches/recommendations to senior management. Support procurement inspections, DCMA/DCAA reviews and internal audits. Performs internal quality reviews of purchase orders/requisitions and file documentation to ensure compliance with procurement policy and procedures/responsibilities. Establish developmental plans for direct reports, including performance planning and development support; coaching and mentoring; rewards and recognition; and staff retention to develop a continuous improvement culture. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. Category: Logistics , Keywords: Purchasing Supervisor
01/20/2021
Full time
This position serves as an integral member of the Contracts, Subcontracts, Procurement & Property (CSPP) department. CSPP strives to provide both its internal and external customers with solution-oriented leadership and guidance and is focused on achieving the strategic objectives of the organization while balancing risk and regulatory compliance. The ideal candidate has an interest in contributing to the success of the entire CSPP department in a fast-paced, multifaceted environment. Reporting to the Associate Director of Procurement and Property, the Government Procurement Lead is responsible to provide supervision and oversight of two Senior Government Buyers along with the execution of all supply chain/purchasing responsibilities for an individual program area. The applicant is responsible for establishing priorities, leading daily activities and ensuring the timely and proper execution for the procurement of all Federal funded purchases in accordance with State/Local and U.S. Government (FAR/DFARS) procurement policies, procedures and regulations. Applicant should have a keen interest in business/contract law and supply chain management and must demonstrate judgement to interpret internal and external issues, develop best practices and provide recommendations to senior CSPP staff. Responsible for training, planning, coordinating, reviewing and approves the work of direct reports involved with the Government procurement process on a daily basis. Applicant will serve as acquisition expert to the Government procurement team purchasing a variety of goods and services to include, but not limited to, construction, information technology, engineering/professional services, material/supplies and more. Serve as the direct link between procurement and the program offices to lead the coordination of supply Chain bid/proposal activities, provide risk management strategies, prepare and execute the PO packages for defined program area. Work closely with the Associate Director of Procurement and Procurement peers to share best practices and continuously identify process improvement opportunities for effective tracking of procurement activities. Work Closely with the Vendor Management Lead in identifying spend patterns, defining the category and commodities to develop the best strategic partnerships and optimize value for the program offices. Collaborate with other functional areas of CSPP, Finance and Administration, Legal and Corporate and promote cooperation and commitment within the team to achieve goals and objectives. Support other special projects and/or represents the department on cross-functional teams as assigned by the Associate Director of Procurement and Property. As directed, supports the development of CSPP department-wide policies and procedures. Provide training and direction to subordinates based on departmental policies, purchasing/contractual terms, FAR/DFARS requirements, compliance issues and system requirements. Negotiates purchase orders including price/cost and coordinates negotiations of terms and conditions with the internal legal team and CSPP leadership if necessary. Identify risk in terms and conditions that deviate from company policy. Support senior CSPP staff in developing and presenting risk mitigation approaches/recommendations to senior management. Support procurement inspections, DCMA/DCAA reviews and internal audits. Performs internal quality reviews of purchase orders/requisitions and file documentation to ensure compliance with procurement policy and procedures/responsibilities. Establish developmental plans for direct reports, including performance planning and development support; coaching and mentoring; rewards and recognition; and staff retention to develop a continuous improvement culture. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. Category: Logistics , Keywords: Purchasing Supervisor
Director of Risk Management
CRISPR Therapeutics Cambridge, Massachusetts
Company Overview At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases. We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases. Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients. Job Summary We are seeking a talented and motivated medical expert focused on pharmacovigilance and risk management Director to join our growing Research and Development organization. Reporting into the Global Head of Pharmacovigilance, you will be a key member of the Development organization, working closely with cross-functional teams. You will have the opportunity to provide strategic direction using your medical/ clinical/ Pharmacovigilance expertise to ensure successful product development and approval in alignment with company objectives. In advancing several product candidates into clinical stage, CRISPR Therapeutics will offer the right individuals the opportunity to devise and implement creative risk management within global Pharmacovigilance concept to bring novel products to patients as quickly, robustly and efficiently as possible, and to shape the regulated environment in which we operate. The position provides an excellent opportunity to apply your current medical knowledge and gain experience in the fast growing and advancing field of gene and cellular therapies. Responsibilities Providing medical review and management of all safety cases received globally from clinical trials and spontaneous sources Overseeing and managing the global interaction and communication with CRISPR affiliates and colleagues responsible for day to day safety cases management globally (e.g. Pharmacovigilance vendor, clinical development, partners, etc.) Ensuring appropriate medical safety assessments and surveillance of safety cases on daily basis working closely with Pharmacovigilance vendor Managing the overall periodic literature monitoring, safety data and signal evaluation of CRISPR TX investigational and marketed products for the purpose of periodic regulatory reporting as well as any updates needed for the safety profile of CRISPR TX investigational and marketed products Ensuring compliance with global regulatory authority reporting, and communication of safety information for assigned products as well as keeping abreast of medical information on targeted therapeutic area as well as Pharmacovigilance methods and trends in published literature and global regulations Providing medical review for safety cases (clinical, spontaneous, literature, etc.), including coding, seriousness, expectedness and company causality assessment for CRISPR TX products in compliance with current global regulations, internal and external guidance documents, Standard Operating Procedures, Safety Pharmacovigilance management plan, the safety database User Reference Guide and case processing/coding conventions Ensuring the quality of the cases prepared by safety contractors and that appropriate medical interpretation and consistency are applied to adverse event assessment. Ensuring that appropriate follow-ups are performed for the safety cases received by the contractor Assisting in obtaining additional follow-up reports from clinical sites and health care professionals as needed Interacting closely with QA or other relevant functions per internal CRISPR TX SOPs to address adverse events associated with product complaint Assisting in review of the materials generated from Clinical Development and Medical Affairs for communication of safety related topics Proactively performing aggregate safety data review, safety surveillance activities to review for potential safety signals and provide input to documents such as PSURs/PBRERs, DSURs/periodic reports, RMPs and documents such as CCDS in close collaboration with CRISPR TX pharmacovigilance and Clinical Development team Working closely with Pharmacovigilance team to ensure timely submission/ distribution of the expedited individual case safety reports/ SUSARs Providing medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities Reviewing and providing assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigators' Brochures, DSUR, PSURs/PBRERs, RMPs and ad hoc regulatory reports as assigned. This includes input to PSURs/PBRERs and DSUR/periodic report with focus on providing overview for the medical analysis and safety sections Managing global literature monitoring process and interact with the external vendors as relevant to ensure proper documentation Reviewing and identifying any relevant safety information from the literature articles and address them according to the internal process and global requirements Supporting clinical development team as needed with safety review of the clinical documents (e.g. clinical trial protocol, CRF, IB, CSR, periodic T&L review etc.) and safety report handling and providing medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation Representing Global PVRM Team in the periodic clinical data review process Leading signal detection process and the signal detection meetings and keep record of all decisions based on required global requirements and internal processes Contributing to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed Qualifications MD Degree with minimum of 5-8 years of relevant experience in Clinical Practice, Pharmacovigilance or Clinical Research Excellent knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of post marketing spontaneous and clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports Strong leadership, verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management. Ability to understand scientific/clinical information and apply communication, negotiation and organizational skills to interact seamlessly both internally and externally on strategic, operational and scientific matters. Ability to anticipate and mitigate against future strategic issues, uncertainties and risks. Ability to make complex decisions and set priorities, and to propose creative problem resolution with the willingness to take informed risks and act decisively. Ability to apply conflict management skills, resolve issues, develop a course of action and apply organizational skills to advance projects in challenging situations. Experience in business change management and implementation desirable. Quintessential team player dedicated to the success of the team and company above self. Contribute to a world-class, results-oriented team by setting clear expectations and holding people accountable. Superior ethics and integrity. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link:
01/20/2021
Full time
Company Overview At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases. We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases. Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients. Job Summary We are seeking a talented and motivated medical expert focused on pharmacovigilance and risk management Director to join our growing Research and Development organization. Reporting into the Global Head of Pharmacovigilance, you will be a key member of the Development organization, working closely with cross-functional teams. You will have the opportunity to provide strategic direction using your medical/ clinical/ Pharmacovigilance expertise to ensure successful product development and approval in alignment with company objectives. In advancing several product candidates into clinical stage, CRISPR Therapeutics will offer the right individuals the opportunity to devise and implement creative risk management within global Pharmacovigilance concept to bring novel products to patients as quickly, robustly and efficiently as possible, and to shape the regulated environment in which we operate. The position provides an excellent opportunity to apply your current medical knowledge and gain experience in the fast growing and advancing field of gene and cellular therapies. Responsibilities Providing medical review and management of all safety cases received globally from clinical trials and spontaneous sources Overseeing and managing the global interaction and communication with CRISPR affiliates and colleagues responsible for day to day safety cases management globally (e.g. Pharmacovigilance vendor, clinical development, partners, etc.) Ensuring appropriate medical safety assessments and surveillance of safety cases on daily basis working closely with Pharmacovigilance vendor Managing the overall periodic literature monitoring, safety data and signal evaluation of CRISPR TX investigational and marketed products for the purpose of periodic regulatory reporting as well as any updates needed for the safety profile of CRISPR TX investigational and marketed products Ensuring compliance with global regulatory authority reporting, and communication of safety information for assigned products as well as keeping abreast of medical information on targeted therapeutic area as well as Pharmacovigilance methods and trends in published literature and global regulations Providing medical review for safety cases (clinical, spontaneous, literature, etc.), including coding, seriousness, expectedness and company causality assessment for CRISPR TX products in compliance with current global regulations, internal and external guidance documents, Standard Operating Procedures, Safety Pharmacovigilance management plan, the safety database User Reference Guide and case processing/coding conventions Ensuring the quality of the cases prepared by safety contractors and that appropriate medical interpretation and consistency are applied to adverse event assessment. Ensuring that appropriate follow-ups are performed for the safety cases received by the contractor Assisting in obtaining additional follow-up reports from clinical sites and health care professionals as needed Interacting closely with QA or other relevant functions per internal CRISPR TX SOPs to address adverse events associated with product complaint Assisting in review of the materials generated from Clinical Development and Medical Affairs for communication of safety related topics Proactively performing aggregate safety data review, safety surveillance activities to review for potential safety signals and provide input to documents such as PSURs/PBRERs, DSURs/periodic reports, RMPs and documents such as CCDS in close collaboration with CRISPR TX pharmacovigilance and Clinical Development team Working closely with Pharmacovigilance team to ensure timely submission/ distribution of the expedited individual case safety reports/ SUSARs Providing medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities Reviewing and providing assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigators' Brochures, DSUR, PSURs/PBRERs, RMPs and ad hoc regulatory reports as assigned. This includes input to PSURs/PBRERs and DSUR/periodic report with focus on providing overview for the medical analysis and safety sections Managing global literature monitoring process and interact with the external vendors as relevant to ensure proper documentation Reviewing and identifying any relevant safety information from the literature articles and address them according to the internal process and global requirements Supporting clinical development team as needed with safety review of the clinical documents (e.g. clinical trial protocol, CRF, IB, CSR, periodic T&L review etc.) and safety report handling and providing medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation Representing Global PVRM Team in the periodic clinical data review process Leading signal detection process and the signal detection meetings and keep record of all decisions based on required global requirements and internal processes Contributing to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed Qualifications MD Degree with minimum of 5-8 years of relevant experience in Clinical Practice, Pharmacovigilance or Clinical Research Excellent knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of post marketing spontaneous and clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports Strong leadership, verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management. Ability to understand scientific/clinical information and apply communication, negotiation and organizational skills to interact seamlessly both internally and externally on strategic, operational and scientific matters. Ability to anticipate and mitigate against future strategic issues, uncertainties and risks. Ability to make complex decisions and set priorities, and to propose creative problem resolution with the willingness to take informed risks and act decisively. Ability to apply conflict management skills, resolve issues, develop a course of action and apply organizational skills to advance projects in challenging situations. Experience in business change management and implementation desirable. Quintessential team player dedicated to the success of the team and company above self. Contribute to a world-class, results-oriented team by setting clear expectations and holding people accountable. Superior ethics and integrity. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link:
Food Science - Beverage
TreeHouse Foods, Inc. Cambridge, Maryland
Employee Type: Full time Location: MD Cambridge Job Type: Research and Development Job Posting Title: Food Science - Beverage Job Description: Under limited supervision, leads the design, planning, validation, and implementation of new products, line extensions, product improvement and technical service for TreeHouse Foods that meet product offering requirements. Position Responsibilities: Under limited supervision, works collaboratively in the execution of development from bench to production scale for new products, product improvements and cost savings projects. Defines the formulation, nutritional and process parameters needed to develop a product which meets the project objective(s). Understands the impact of these parameters to overall project. Applies sound scientific methods in all stages of development. Including planning and executing trials, analyzing data and defining solutions to achieve project goals. Identifies opportunities for competitive market advantage Provide judgement and experience to assure that an appropriate level of technical knowledge and discipline are being applied and utilized in business decisions Partner and communicate effectively with cross-functional groups: Marketing, Sales, QA, Procurement, Finance, Operations and Engineering Ensure the transfer of technology to the operations team when commercializing products. Provide technical oversight of internal and external manufacturing start-ups and ongoing technical service Contribute significantly and continually to attain results through the generation and application of advanced, specialized knowledge Generate and support pipeline work to drive cost optimization through formulation and processing efficiencies Participates in customer presentations and/or preparing product, content for customer meetings Ensure all activities follow established safety standards, regulatory requirements (FDA, UDSA & Kosher) and Good Manufacturing Procedures (GMP) Qualifications and Requirements: Three years' experience in Food Science Product Development OR No experience required if holding a PhD in Food Science/Engineering or Related Field Retort and/or aseptic product experience preferred Understanding of ingredient interactions/functionality Communicate effectively and openly while working in a cross-functional team. Must be a self-starter, independent, energetic and resourceful Excellent written and verbal communications skills Solid Project Management skills and experience Aptitude for technical leadership and project management Education: Bachelor's Degree Required - Type: Food Science/Engineering or Related Field Master's Degree Required -- Type: Food Science/Engineering or Related Field Travel: Up to 30% Disability Assistance TreeHouse Foods is an Equal Employment Opportunity Employer and offers opportunities to all job seekers, including those with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to . In your email please include a description of the specific accommodation you are requesting and a description of the position for which you are applying. EEO Considerations All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
01/20/2021
Full time
Employee Type: Full time Location: MD Cambridge Job Type: Research and Development Job Posting Title: Food Science - Beverage Job Description: Under limited supervision, leads the design, planning, validation, and implementation of new products, line extensions, product improvement and technical service for TreeHouse Foods that meet product offering requirements. Position Responsibilities: Under limited supervision, works collaboratively in the execution of development from bench to production scale for new products, product improvements and cost savings projects. Defines the formulation, nutritional and process parameters needed to develop a product which meets the project objective(s). Understands the impact of these parameters to overall project. Applies sound scientific methods in all stages of development. Including planning and executing trials, analyzing data and defining solutions to achieve project goals. Identifies opportunities for competitive market advantage Provide judgement and experience to assure that an appropriate level of technical knowledge and discipline are being applied and utilized in business decisions Partner and communicate effectively with cross-functional groups: Marketing, Sales, QA, Procurement, Finance, Operations and Engineering Ensure the transfer of technology to the operations team when commercializing products. Provide technical oversight of internal and external manufacturing start-ups and ongoing technical service Contribute significantly and continually to attain results through the generation and application of advanced, specialized knowledge Generate and support pipeline work to drive cost optimization through formulation and processing efficiencies Participates in customer presentations and/or preparing product, content for customer meetings Ensure all activities follow established safety standards, regulatory requirements (FDA, UDSA & Kosher) and Good Manufacturing Procedures (GMP) Qualifications and Requirements: Three years' experience in Food Science Product Development OR No experience required if holding a PhD in Food Science/Engineering or Related Field Retort and/or aseptic product experience preferred Understanding of ingredient interactions/functionality Communicate effectively and openly while working in a cross-functional team. Must be a self-starter, independent, energetic and resourceful Excellent written and verbal communications skills Solid Project Management skills and experience Aptitude for technical leadership and project management Education: Bachelor's Degree Required - Type: Food Science/Engineering or Related Field Master's Degree Required -- Type: Food Science/Engineering or Related Field Travel: Up to 30% Disability Assistance TreeHouse Foods is an Equal Employment Opportunity Employer and offers opportunities to all job seekers, including those with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to . In your email please include a description of the specific accommodation you are requesting and a description of the position for which you are applying. EEO Considerations All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Automation Engineer
Amgen Cambridge, Massachusetts
JOB SUMMARY The Automation Engineer will be responsible for Developing and supporting process control applications utilizing Distributed Control Systems (DCS), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA), and Programmable Logic Controllers (PLC). Amgen is looking for an Automation Engineer to join our Scale-Up Lab team in Cambridge, Massachusetts. This role will support complex automation initiatives in a dynamic and innovative environment. The role will comprise supporting ongoing biological processes and technology development projects through maintaining automation systems, providing engineering design, and managing small projects. Strong ability to work in cross-functional teams is important. Responsibilities: o Lead and support of both departmental and capital projects. Responsible for the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope. Provide understanding of project life cycles o Work directly with and communicate to scientific and operational staff to help translate process requirements into automation and engineering design o Responsible for industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP o Development of detailed specification, engineering documents, SOP and operating standards o Ownership and administration of process control automation in process development pilot manufacturing settings o Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems o Design and test of newly installed and currently installed automated process equipment o Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs o Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles o Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations o Work schedule flexibility to support pilot plant operations and project requirements. Basic Qualifications Master's degree and 2 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Associate's degree and 8 years of Engineering experience Preferred Qualifications o B.S or M.S. in Chemical Engineering, Biotech Engineering, Electrical Engineering, Computer Science or related life science engineering. o Direct experience with bioprocess unit operations such bioreactors, chromatography, filtration, etc. o Strong control system automation background focused specifically in design, installation, programming and validation of automated processes o 2+ years combined experience with Emerson DeltaV DCS systems version 12 or above o Strong leadership, technical writing, and communication/presentation skills especially with engineering documentation o Working knowledge of manufacturing IT networks o Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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.
01/19/2021
Full time
JOB SUMMARY The Automation Engineer will be responsible for Developing and supporting process control applications utilizing Distributed Control Systems (DCS), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA), and Programmable Logic Controllers (PLC). Amgen is looking for an Automation Engineer to join our Scale-Up Lab team in Cambridge, Massachusetts. This role will support complex automation initiatives in a dynamic and innovative environment. The role will comprise supporting ongoing biological processes and technology development projects through maintaining automation systems, providing engineering design, and managing small projects. Strong ability to work in cross-functional teams is important. Responsibilities: o Lead and support of both departmental and capital projects. Responsible for the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope. Provide understanding of project life cycles o Work directly with and communicate to scientific and operational staff to help translate process requirements into automation and engineering design o Responsible for industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP o Development of detailed specification, engineering documents, SOP and operating standards o Ownership and administration of process control automation in process development pilot manufacturing settings o Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems o Design and test of newly installed and currently installed automated process equipment o Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs o Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles o Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations o Work schedule flexibility to support pilot plant operations and project requirements. Basic Qualifications Master's degree and 2 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Associate's degree and 8 years of Engineering experience Preferred Qualifications o B.S or M.S. in Chemical Engineering, Biotech Engineering, Electrical Engineering, Computer Science or related life science engineering. o Direct experience with bioprocess unit operations such bioreactors, chromatography, filtration, etc. o Strong control system automation background focused specifically in design, installation, programming and validation of automated processes o 2+ years combined experience with Emerson DeltaV DCS systems version 12 or above o Strong leadership, technical writing, and communication/presentation skills especially with engineering documentation o Working knowledge of manufacturing IT networks o Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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.
Research Associate, Cell Differentiation
Sana Biotechnology Cambridge, Massachusetts
JOB PURPOSE We are seeking a passionate and detail-oriented laboratory scientist with experience in mammalian or pluripotent stem cell culture to join a growing cell differentiation team. Under the supervision of a Senior Director, the associate will be responsible for daily tasks involving the growth, differentiation, and characterization of pluripotent stem cells to support cell-based therapeutic programs. DUTIES AND RESPONSIBILITIES Culture and differentiation of pluripotent stem cells. Analysis of differentiated cell products (Flow cytometry, PCR, fluorescent microscopy, etc). Participate in the planning, design and execution of experiments. Make observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Present results of experiments and findings in informal, small group settings. Coordinate with other team members as necessary to ensure the completion of the team's research projects. Comply with standard laboratory practices and company policies. QUALIFICATIONS Bachelors' degree in a scientific discipline with experience usually garnered during a minimum of 2+ years of laboratory experience- including internship and co-op experience. Demonstrated expertise in basic laboratory techniques and functions is required as is proficiency in common office software (typically Microsoft Word, Excel and PowerPoint). Prior experience with mammalian cell culture is required; experience with pluripotent cell culture is preferred.
01/19/2021
Full time
JOB PURPOSE We are seeking a passionate and detail-oriented laboratory scientist with experience in mammalian or pluripotent stem cell culture to join a growing cell differentiation team. Under the supervision of a Senior Director, the associate will be responsible for daily tasks involving the growth, differentiation, and characterization of pluripotent stem cells to support cell-based therapeutic programs. DUTIES AND RESPONSIBILITIES Culture and differentiation of pluripotent stem cells. Analysis of differentiated cell products (Flow cytometry, PCR, fluorescent microscopy, etc). Participate in the planning, design and execution of experiments. Make observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Present results of experiments and findings in informal, small group settings. Coordinate with other team members as necessary to ensure the completion of the team's research projects. Comply with standard laboratory practices and company policies. QUALIFICATIONS Bachelors' degree in a scientific discipline with experience usually garnered during a minimum of 2+ years of laboratory experience- including internship and co-op experience. Demonstrated expertise in basic laboratory techniques and functions is required as is proficiency in common office software (typically Microsoft Word, Excel and PowerPoint). Prior experience with mammalian cell culture is required; experience with pluripotent cell culture is preferred.
Global Patient Safety Physician- Rare Disease
Ipsen Biopharmaceuticals, Inc. Cambridge, Massachusetts
Title: Global Patient Safety Physician- Rare Disease Company: Clementia Pharmaceuticals USA, Inc. Job Description: Do you have medical, technical and scientific expertise in safety data collection, evaluation and medical interpretation? As Global Patient Safety (GPS) Physician, focused in Rare Disease, you will ensure effective and proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met. You will be an active member of the Global Product Team and Clinical Development Team for one or more products, as required and as delegated by the respective GPS TA Leader, and as such be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s). Additionally, you will support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments.Your role will involve: Ensure proactive safety and risk management for all assigned products Through an 'Integrated Safety Sciences' collaborative approach, implement proactive safety and risk management strategies, agreed cross-functionally with product team colleagues, for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy Lead the development of the Risk Management Plan for assigned products as applicable Support safety decision-making for benefit-risk assessment Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data Provide medical support (and leadership as delegated by the respective GPS TA Leader) for all safety components of regulatory submissions, health authority safety-related questions, and periodic safety reports (PSURs, PBRERs, DSURs) Contribute effectively in internal interactions and cross-functional teams Ensure up-to-date oversight of the emerging safety profiles for all TA products Ensure continuous assessment of all new safety information, through the 'Integrated Safety Sciences' collaborative approach Lead signal detection and signal evaluation activities for assigned products Collaborate closely with Global Drug Development and Medical Affairs on safety of patients participating in clinical studies including the operation of Data Safety Monitoring Boards GPS Product Leader role for the assigned product(s), ensuring appropriate medical safety input to all safety-related issues and questions Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decision are made Contribute effectively in external interactions, eg SMCs/IDMCs; preparation of the medical safety aspects for, and attendance at, regulatory authority meetings; interactions with external advisers or opinion leaders; collaboration with colleagues from partnership companies for co-development or co-marketing etc As delegated by the GPS TA Leader, provide medical safety expertise for due diligence activities, preparing an integrated safety assessment for consideration by senior management Contribute to the overall success of Global Patient Safety and Ipsen Provide TA and product-specific training within GPS and more widely within the company and for external vendors as required In return, you will bring: Medical Degree Physician with proven clinical ability exercising medical judgment as a physician Fluent in written and spoken English Industry experience in either clinical development or pharmacovigilance Knowledge of product development processes and experience of cross-functional team work Working knowledge of pharmacovigilance legislation Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file Apply today to apply your knowledge and medical expertise on our global patient safety team! 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.","datePosted":"2020-11-19T00:00:00.000Z
01/19/2021
Full time
Title: Global Patient Safety Physician- Rare Disease Company: Clementia Pharmaceuticals USA, Inc. Job Description: Do you have medical, technical and scientific expertise in safety data collection, evaluation and medical interpretation? As Global Patient Safety (GPS) Physician, focused in Rare Disease, you will ensure effective and proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met. You will be an active member of the Global Product Team and Clinical Development Team for one or more products, as required and as delegated by the respective GPS TA Leader, and as such be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s). Additionally, you will support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments.Your role will involve: Ensure proactive safety and risk management for all assigned products Through an 'Integrated Safety Sciences' collaborative approach, implement proactive safety and risk management strategies, agreed cross-functionally with product team colleagues, for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy Lead the development of the Risk Management Plan for assigned products as applicable Support safety decision-making for benefit-risk assessment Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data Provide medical support (and leadership as delegated by the respective GPS TA Leader) for all safety components of regulatory submissions, health authority safety-related questions, and periodic safety reports (PSURs, PBRERs, DSURs) Contribute effectively in internal interactions and cross-functional teams Ensure up-to-date oversight of the emerging safety profiles for all TA products Ensure continuous assessment of all new safety information, through the 'Integrated Safety Sciences' collaborative approach Lead signal detection and signal evaluation activities for assigned products Collaborate closely with Global Drug Development and Medical Affairs on safety of patients participating in clinical studies including the operation of Data Safety Monitoring Boards GPS Product Leader role for the assigned product(s), ensuring appropriate medical safety input to all safety-related issues and questions Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decision are made Contribute effectively in external interactions, eg SMCs/IDMCs; preparation of the medical safety aspects for, and attendance at, regulatory authority meetings; interactions with external advisers or opinion leaders; collaboration with colleagues from partnership companies for co-development or co-marketing etc As delegated by the GPS TA Leader, provide medical safety expertise for due diligence activities, preparing an integrated safety assessment for consideration by senior management Contribute to the overall success of Global Patient Safety and Ipsen Provide TA and product-specific training within GPS and more widely within the company and for external vendors as required In return, you will bring: Medical Degree Physician with proven clinical ability exercising medical judgment as a physician Fluent in written and spoken English Industry experience in either clinical development or pharmacovigilance Knowledge of product development processes and experience of cross-functional team work Working knowledge of pharmacovigilance legislation Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file Apply today to apply your knowledge and medical expertise on our global patient safety team! 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.","datePosted":"2020-11-19T00:00:00.000Z
Senior Director, Analytical Development
Sana Biotechnology Cambridge, Massachusetts
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Leader of Analytical Development will oversee the establishment of analytical methods and their intensive application for product and process characterization in early development; by leveraging automation / high-throughput testing and data analysis. With a strong focus on both technical and operational excellence, this senior managerial position will play a leading role in shaping core technology platforms at Sana and the advancement of therapeutic gene and cell therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advance therapies. DUTIES AND RESPONSIBILITIES The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will manage assay establishment, automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development in order to design quality into the Phase 1 CMC packages for novel gene and cell therapies. The individual will play a key role in building out the control strategy for Sana's investigational products, and also participate in cross-functional program teams. The successful candidate will have industrial experience managing an analytical development team for biologics/vaccines (and/or preferably gene/cell therapy), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team. Responsibilities: Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic. Build and manage a high-throughput / automated testing capability (non-GMP) to support CMC development of Sana's gene and cell therapy programs. Adapt methods for the throughput and technical demands of fast-paced early development programs. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical. Hire and manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges. With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA). QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a leader; has experience managing department(s) with mid level and senior employees. Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, HPLC, automated liquid handling, electronic notebooks. Prior experience leading a team in Analytical method development, testing, QC, or stability is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities.
01/19/2021
Full time
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Leader of Analytical Development will oversee the establishment of analytical methods and their intensive application for product and process characterization in early development; by leveraging automation / high-throughput testing and data analysis. With a strong focus on both technical and operational excellence, this senior managerial position will play a leading role in shaping core technology platforms at Sana and the advancement of therapeutic gene and cell therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advance therapies. DUTIES AND RESPONSIBILITIES The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will manage assay establishment, automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development in order to design quality into the Phase 1 CMC packages for novel gene and cell therapies. The individual will play a key role in building out the control strategy for Sana's investigational products, and also participate in cross-functional program teams. The successful candidate will have industrial experience managing an analytical development team for biologics/vaccines (and/or preferably gene/cell therapy), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team. Responsibilities: Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic. Build and manage a high-throughput / automated testing capability (non-GMP) to support CMC development of Sana's gene and cell therapy programs. Adapt methods for the throughput and technical demands of fast-paced early development programs. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical. Hire and manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges. With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA). QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a leader; has experience managing department(s) with mid level and senior employees. Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, HPLC, automated liquid handling, electronic notebooks. Prior experience leading a team in Analytical method development, testing, QC, or stability is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities.
Senior Research Associate, Protein Engineering
Sana Biotechnology Cambridge, Massachusetts
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
01/19/2021
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
Director of Parking and Commuter Choice #53111BR
Harvard University Cambridge, Massachusetts
Director of Parking and Commuter Choice Campus Services 53111BR Job Summary Directs the University parking system for the Cambridge and Allston campuses. Oversees Parking Operations, Parking Facilities, and the CommuterChoice program to ensure the successful operation and integration at the highest levels of customer service for University parking and its alternative multi-dimensional transportation programs. Assists the Managing Director of Transportation and the Campus Service Center with strategic planning incorporating, operations, events management, facilities management, capital planning, IT systems, access and revenue control, audit, and finances. Oversees budget planning for numerous cost centers, and manages a number of parking operations for the Harvard Housing and Real Estate groups. Job-Specific Responsibilities Develops and implements Parking policies and procedures and ensures enforcement guidelines are followed. Develops parking strategies in partnership with senior operations management with Multi-School faculties to meet University needs and changes in demand. Works with the Managing Director of Transportation Services on the development of integrated parking and alternative transportation strategies and initiatives. Oversees and evaluates the Associate Director of Parking Operations, Associate Director of Parking Facilities and the Associate Director of CommuterChoice in accordance with established performance management plans. Develops, administers and analyzes the operating budgets and business plans for Parking-owned lots and garages and facilities owned by Harvard Housing and Harvard Real Estate Services that are managed by Parking Services. Reviews monthly, quarterly and annual financial reports. Manages the Parking Services' reserve accounts and oversees department funding models. Works closely with the Office of Finance, Strategy and Planning and the Campus Services financial team to review parking financial strategies. Approves Parking Services' communication including the distribution of announcements, transportation advisories, written literature and web text. Project manages parking initiatives and submits parking capital projects for review during closeout process. Negotiates vendor contracts with support from the Procurement Office. Assists the Managing Director of Transportation with evaluating of competitive bids on major parking construction and restoration projects. Reviews new garage and lane designs and makes recommendations as it relates to the operation. Jointly manages the parking inventory with the Harvard Planning and Project Management Office. Oversees process of city permits and garage, gasoline and open-air licenses. Oversees the proper maintenance of all parking facilities with the Associate Director of Parking Facilities including regular building operations, repairs, renovations, projects and snow removal. Oversees with the AD of Parking Operations the parking enforcing program and all events management programs for various schools, departments and the university which involve parking and logistical support. Approves PTDM and DEP regulatory documentation prepared by the Associate Director of CommuterChoice. Helps develop and oversee enhancements to alternate transportation programs such as car sharing, bike sharing, carpooling, walking and public transport. Works closely with the Harvard University Information Technology (HUIT) team to develop management information systems strategies and integration for Parking Services' software applications, databases, access control equipment and on-line services such as the renewal and one day online websites. Represents Parking Services during HUSPMGU union contract negotiations. Responds to grievances as needed and approves all disciplinary action plans. Serves as member of the Transportation emergency management team. Works closely with other Transportation departments such as Shuttle Services and Passenger Transport, Mail Services and Fleet Services and the Campus Service Center to provide seamless service to customers. Participates in transportation planning and development efforts in association with other university departments, community action groups and local government agencies. Actively involved in parking and transportation professional groups such as IPMI, NPA, NEPC, and ACT. Performs other related duties as required and delegated. Basic Qualifications Minimum of a bachelor's degree in business management, accounting, finance, real estate management, transportation planning or retail customer service management with at least ten years' experience of managing in a large matrix organization. Master's degree in an above discipline is a plus. Must have strong communication, organization and problem-solving skills. Demonstrated ability to develop and build strong personal relationships and work within a highly functional team environment required. Demonstrated ability to negotiate effectively and successfully resolve customer service conflicts required. National industry certification in an above desired area of management is preferred. Additional Qualifications and Skills Must have strong computer skills including in-depth experience with industry software applications, Microsoft spreadsheet and word processing software packages. Database management a plus. Additional Information Emergency Status Designation: Critical Personnel Job Function General Administration Location USA - MA - Cambridge Job Code 361060 Administrative Manager Sub-Unit Transportation Department 102391 Time Status Full-time Salary Grade 060 Union 00 - Non Union, Exempt or Temporary Pre-Employment Screening Education, Employment, Identity EEO Statement We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. recblid hn6iqk5b4gj534cpw11x9g10mryzx1
01/18/2021
Full time
Director of Parking and Commuter Choice Campus Services 53111BR Job Summary Directs the University parking system for the Cambridge and Allston campuses. Oversees Parking Operations, Parking Facilities, and the CommuterChoice program to ensure the successful operation and integration at the highest levels of customer service for University parking and its alternative multi-dimensional transportation programs. Assists the Managing Director of Transportation and the Campus Service Center with strategic planning incorporating, operations, events management, facilities management, capital planning, IT systems, access and revenue control, audit, and finances. Oversees budget planning for numerous cost centers, and manages a number of parking operations for the Harvard Housing and Real Estate groups. Job-Specific Responsibilities Develops and implements Parking policies and procedures and ensures enforcement guidelines are followed. Develops parking strategies in partnership with senior operations management with Multi-School faculties to meet University needs and changes in demand. Works with the Managing Director of Transportation Services on the development of integrated parking and alternative transportation strategies and initiatives. Oversees and evaluates the Associate Director of Parking Operations, Associate Director of Parking Facilities and the Associate Director of CommuterChoice in accordance with established performance management plans. Develops, administers and analyzes the operating budgets and business plans for Parking-owned lots and garages and facilities owned by Harvard Housing and Harvard Real Estate Services that are managed by Parking Services. Reviews monthly, quarterly and annual financial reports. Manages the Parking Services' reserve accounts and oversees department funding models. Works closely with the Office of Finance, Strategy and Planning and the Campus Services financial team to review parking financial strategies. Approves Parking Services' communication including the distribution of announcements, transportation advisories, written literature and web text. Project manages parking initiatives and submits parking capital projects for review during closeout process. Negotiates vendor contracts with support from the Procurement Office. Assists the Managing Director of Transportation with evaluating of competitive bids on major parking construction and restoration projects. Reviews new garage and lane designs and makes recommendations as it relates to the operation. Jointly manages the parking inventory with the Harvard Planning and Project Management Office. Oversees process of city permits and garage, gasoline and open-air licenses. Oversees the proper maintenance of all parking facilities with the Associate Director of Parking Facilities including regular building operations, repairs, renovations, projects and snow removal. Oversees with the AD of Parking Operations the parking enforcing program and all events management programs for various schools, departments and the university which involve parking and logistical support. Approves PTDM and DEP regulatory documentation prepared by the Associate Director of CommuterChoice. Helps develop and oversee enhancements to alternate transportation programs such as car sharing, bike sharing, carpooling, walking and public transport. Works closely with the Harvard University Information Technology (HUIT) team to develop management information systems strategies and integration for Parking Services' software applications, databases, access control equipment and on-line services such as the renewal and one day online websites. Represents Parking Services during HUSPMGU union contract negotiations. Responds to grievances as needed and approves all disciplinary action plans. Serves as member of the Transportation emergency management team. Works closely with other Transportation departments such as Shuttle Services and Passenger Transport, Mail Services and Fleet Services and the Campus Service Center to provide seamless service to customers. Participates in transportation planning and development efforts in association with other university departments, community action groups and local government agencies. Actively involved in parking and transportation professional groups such as IPMI, NPA, NEPC, and ACT. Performs other related duties as required and delegated. Basic Qualifications Minimum of a bachelor's degree in business management, accounting, finance, real estate management, transportation planning or retail customer service management with at least ten years' experience of managing in a large matrix organization. Master's degree in an above discipline is a plus. Must have strong communication, organization and problem-solving skills. Demonstrated ability to develop and build strong personal relationships and work within a highly functional team environment required. Demonstrated ability to negotiate effectively and successfully resolve customer service conflicts required. National industry certification in an above desired area of management is preferred. Additional Qualifications and Skills Must have strong computer skills including in-depth experience with industry software applications, Microsoft spreadsheet and word processing software packages. Database management a plus. Additional Information Emergency Status Designation: Critical Personnel Job Function General Administration Location USA - MA - Cambridge Job Code 361060 Administrative Manager Sub-Unit Transportation Department 102391 Time Status Full-time Salary Grade 060 Union 00 - Non Union, Exempt or Temporary Pre-Employment Screening Education, Employment, Identity EEO Statement We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. recblid hn6iqk5b4gj534cpw11x9g10mryzx1
Senior Biopharmaceutical Attorney
Intellia Therapeutics Cambridge, Massachusetts
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: We are seeking an experienced biopharmaceutical attorney to join and grow with our team as we develop human therapeutics using CRISPR/Cas9 technology. The ideal candidate has a strong background in the biotechnology industry supporting regulatory, clinical, and commercial teams, and wants to expand her or his legal experience in a rapidly-growing company. We are looking for someone who can learn quickly, develop and implement solutions, appropriately analyze and manage risks, multitask, and communicate well. We seek a team member who wants to be fully integrated into every aspect of the company from research to business execution. 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 support, identify and resolve critical legal and business issues arising from regulatory, pre-clinical, clinical, technical operations, and research and development activities. (Commercial support experience preferred but not necessary.) Analyze company activities for compliance with evolving legal and regulatory landscape. Conduct legal research, as needed Advise on the interpretation of legal documents and applicable laws and regulations in a manner that provides practical legal advice while properly managing risk to the organization. Act as the legal representative on cross-functional teams, such as program teams or Intellia's medical and legal review team. With our contracts team, draft and negotiate contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements. Review presentations, press releases, website materials, brochures, and other company communications (internal and external). Support third party relationship management. Counsel, advise and train internal client team to ensure compliance with applicable laws and regulations and company policies and procedures; and Help with general corporate matters. Qualifications: Licensed attorney with 3-6 years of experience in the biotechnology/pharmaceutical industry (public company experience strongly preferred). Sound business judgment; strategic and analytical thinking. Self-motivated, flexible and interested in working on a wide range of legal matters in order to understand and advise the Company on legal implications of its business strategy. Strong base of knowledge and experience advising clients on laws and regulations governing the biotechnology industry both in and outside the U.S., including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, and product liability laws, and similar laws outside the U.S. Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to senior management and others. Excellent organizational skills and able to work with a team to meet critical deadlines; flexible and capable of managing multiple projects simultaneously. Attention to details Attracting and developing talent/building a successful team Exceptional time management Effective communication skills (oral and written) #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.
01/18/2021
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: We are seeking an experienced biopharmaceutical attorney to join and grow with our team as we develop human therapeutics using CRISPR/Cas9 technology. The ideal candidate has a strong background in the biotechnology industry supporting regulatory, clinical, and commercial teams, and wants to expand her or his legal experience in a rapidly-growing company. We are looking for someone who can learn quickly, develop and implement solutions, appropriately analyze and manage risks, multitask, and communicate well. We seek a team member who wants to be fully integrated into every aspect of the company from research to business execution. 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 support, identify and resolve critical legal and business issues arising from regulatory, pre-clinical, clinical, technical operations, and research and development activities. (Commercial support experience preferred but not necessary.) Analyze company activities for compliance with evolving legal and regulatory landscape. Conduct legal research, as needed Advise on the interpretation of legal documents and applicable laws and regulations in a manner that provides practical legal advice while properly managing risk to the organization. Act as the legal representative on cross-functional teams, such as program teams or Intellia's medical and legal review team. With our contracts team, draft and negotiate contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements. Review presentations, press releases, website materials, brochures, and other company communications (internal and external). Support third party relationship management. Counsel, advise and train internal client team to ensure compliance with applicable laws and regulations and company policies and procedures; and Help with general corporate matters. Qualifications: Licensed attorney with 3-6 years of experience in the biotechnology/pharmaceutical industry (public company experience strongly preferred). Sound business judgment; strategic and analytical thinking. Self-motivated, flexible and interested in working on a wide range of legal matters in order to understand and advise the Company on legal implications of its business strategy. Strong base of knowledge and experience advising clients on laws and regulations governing the biotechnology industry both in and outside the U.S., including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, and product liability laws, and similar laws outside the U.S. Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to senior management and others. Excellent organizational skills and able to work with a team to meet critical deadlines; flexible and capable of managing multiple projects simultaneously. Attention to details Attracting and developing talent/building a successful team Exceptional time management Effective communication skills (oral and written) #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.
Director Oncology Business Development (Cambridge, MA or Paris, France
Ipsen Biopharmaceuticals, Inc. Cambridge, Massachusetts
Title: Director Oncology Business Development (Cambridge, MA or Paris, France) Company: Ipsen Bioscience, Inc. Job Description: Location: Cambridge, MA or Paris, France Company Profile: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs. We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our United States and Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations. Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve. Responsibilities Responsibilities will include, but are not limited to, the following: Provide support to VP to optimize deal flow (process and execution), BD strategy in and visibility of Ipsen as partner-of-choice in Oncology Manage due diligence, and structure and negotiate transactions, including in/out-licensing deals, product acquisitions, strategic partnerships and M&As Collaborate with VP (where relevant) and stakeholder functions (including but not limited to country/regional leadership, Commercial Franchises, R&D, IP, Finance, Legal, Manufacturing and Corporate Strategy) to: (a) Establish BD strategy & goals for Oncology that are aligned with overall business/corporate strategy and objectives (b) Ensure high-quality due diligences (c) Execute value-add deals Ensure transactions support Ipsen's strategy in Oncology for assets across all stages of development and commercialization/marketing Lead multi-functional due diligence for robust assessment of opportunities to support decision-making in the BD process, and contracting/negotiations Ensure appropriate documentation of due diligence findings, and review and approval by respective functions Lead (or co-lead with VP where relevant) contract negotiations and work cross-functionally with colleagues from all stakeholder functions (including but not limited to Legal, IP, Finance, R&D, Commercial and Manufacturing) to ensure high-quality contracts are negotiated and executed to protect future interests of Ipsen's business Provide concise and accurate updates and documentations to VP and senior management (and committees involving members from the Board of Directors when necessary) for deal review and decision-making Contribute to business strategy through analysis of evolving market, R&D/competitive landscape, Ipsen's needs and objectives in Oncology as well as ensuring alignment with Ipsen's overall corporate strategy and objectives Deliver accurate and timely updates, and provide customized support to VP and Ipsen's Global External Innovation and Partnering leadership for regular review and decision making at senior management level Interface with key stakeholder functions within Ipsen as well as with executives outside Ipsen including individuals at C-level roles. Maintain professional network with external companies and advisers including attendance at appropriate conferences and other industry events Comply with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff Qualifications: Master's degree in Science required Advanced post-graduate degrees including Masters, Ph.D. in Chemistry, Biology or Medicine ideal; Master's in Finance or MBA desirable 5+ years of experience in the pharmaceutical industry with a strong track record of executing BD deals Experience of BD in the R&D and commercial context, ideally with international experience Experience of several therapeutic areas ideal, Oncology required Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) )Excellent team working and relationship/networking skills Excellent verbal, written, interpersonal skills Excellent organization, planning and coordination skills Horned project management skills Solid negotiation skills Strong business and strategic acumen Exceptional awareness of biopharma ecosystem including the deal-making landscape Ability to operate successfully in an international and multicultural environment Strong analytical skills IT systems literacy The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law. Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. 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.","datePosted":"2020-11-23T00:00:00.000Z
01/17/2021
Full time
Title: Director Oncology Business Development (Cambridge, MA or Paris, France) Company: Ipsen Bioscience, Inc. Job Description: Location: Cambridge, MA or Paris, France Company Profile: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs. We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our United States and Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations. Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve. Responsibilities Responsibilities will include, but are not limited to, the following: Provide support to VP to optimize deal flow (process and execution), BD strategy in and visibility of Ipsen as partner-of-choice in Oncology Manage due diligence, and structure and negotiate transactions, including in/out-licensing deals, product acquisitions, strategic partnerships and M&As Collaborate with VP (where relevant) and stakeholder functions (including but not limited to country/regional leadership, Commercial Franchises, R&D, IP, Finance, Legal, Manufacturing and Corporate Strategy) to: (a) Establish BD strategy & goals for Oncology that are aligned with overall business/corporate strategy and objectives (b) Ensure high-quality due diligences (c) Execute value-add deals Ensure transactions support Ipsen's strategy in Oncology for assets across all stages of development and commercialization/marketing Lead multi-functional due diligence for robust assessment of opportunities to support decision-making in the BD process, and contracting/negotiations Ensure appropriate documentation of due diligence findings, and review and approval by respective functions Lead (or co-lead with VP where relevant) contract negotiations and work cross-functionally with colleagues from all stakeholder functions (including but not limited to Legal, IP, Finance, R&D, Commercial and Manufacturing) to ensure high-quality contracts are negotiated and executed to protect future interests of Ipsen's business Provide concise and accurate updates and documentations to VP and senior management (and committees involving members from the Board of Directors when necessary) for deal review and decision-making Contribute to business strategy through analysis of evolving market, R&D/competitive landscape, Ipsen's needs and objectives in Oncology as well as ensuring alignment with Ipsen's overall corporate strategy and objectives Deliver accurate and timely updates, and provide customized support to VP and Ipsen's Global External Innovation and Partnering leadership for regular review and decision making at senior management level Interface with key stakeholder functions within Ipsen as well as with executives outside Ipsen including individuals at C-level roles. Maintain professional network with external companies and advisers including attendance at appropriate conferences and other industry events Comply with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff Qualifications: Master's degree in Science required Advanced post-graduate degrees including Masters, Ph.D. in Chemistry, Biology or Medicine ideal; Master's in Finance or MBA desirable 5+ years of experience in the pharmaceutical industry with a strong track record of executing BD deals Experience of BD in the R&D and commercial context, ideally with international experience Experience of several therapeutic areas ideal, Oncology required Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) )Excellent team working and relationship/networking skills Excellent verbal, written, interpersonal skills Excellent organization, planning and coordination skills Horned project management skills Solid negotiation skills Strong business and strategic acumen Exceptional awareness of biopharma ecosystem including the deal-making landscape Ability to operate successfully in an international and multicultural environment Strong analytical skills IT systems literacy The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law. Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. 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.","datePosted":"2020-11-23T00:00:00.000Z
Clinical Research Associate (II), Rare Disease
Ipsen Biopharmaceuticals, Inc. Cambridge, Massachusetts
Title: Clinical Research Associate (II), Rare Disease Company: Clementia Pharmaceuticals, Inc. Job Description: Are you looking for an opportunity to apply your clinical research monitoring experience in the rare disease therapeutic area? As CRA II you will be responsible for overseeing, coordinating, and executing Phase I - III clinical study protocols while reporting to the Associate Director of Clinical Operations, Rare Disease. Your role will involve: Assist in the design and review of reporting forms, including Case Report Forms, and Informed Consent Forms, as well as other study-specific documentation Perform Case Report Forms review and query generation and resolution against established data review guidelines Manage trial supplies at investigative sites Perform on-site and remote oversight of CRO monitoring Identify critical data or potential gaps using a risk-based approach Review and maintain the Investigator Site Files and the eTMF Assist in the design and execution of clinical studies: Site Selection Plan Investigator's meetings Conduct, or participate in, on-site training of investigative site staff, as assigned Design monitoring tools Conduct GCP monitoring visits at investigative sites (PSV, SIV, RMV and COV) Assess CROs and other clinical research vendors Act as primary project contact to external third parties and clinical site teams Support and prepare investigative for potential Regulatory Audits Manage project timelines and critical path activities Help develop, communicate and manage Company standards and appropriate policies and procedures Work with clinical teams to identify and resolve obstacles Establish and nurture positive relations with project sites and team personnel Perform other related duties as assigned Approximately 30-40% travel required (globally) In return, you will bring: Degree or equivalent in health sciences Minimum 5 years direct experience with Phase I - III clinical trials Minimum 5 years of experience in on-site clinical trials monitoring Working knowledge of regulatory requirements (FDA, ICH) including Good Clinical Practice principles and requirements Demonstrated experience managing project teams and third-party contractors Good knowledge of drug development key steps and actors If this sounds like an exciting opportunity to employ your clinical monitoring experience on a small, global team, apply today! 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.","datePosted":"2020-11-17T00:00:00.000Z
01/17/2021
Full time
Title: Clinical Research Associate (II), Rare Disease Company: Clementia Pharmaceuticals, Inc. Job Description: Are you looking for an opportunity to apply your clinical research monitoring experience in the rare disease therapeutic area? As CRA II you will be responsible for overseeing, coordinating, and executing Phase I - III clinical study protocols while reporting to the Associate Director of Clinical Operations, Rare Disease. Your role will involve: Assist in the design and review of reporting forms, including Case Report Forms, and Informed Consent Forms, as well as other study-specific documentation Perform Case Report Forms review and query generation and resolution against established data review guidelines Manage trial supplies at investigative sites Perform on-site and remote oversight of CRO monitoring Identify critical data or potential gaps using a risk-based approach Review and maintain the Investigator Site Files and the eTMF Assist in the design and execution of clinical studies: Site Selection Plan Investigator's meetings Conduct, or participate in, on-site training of investigative site staff, as assigned Design monitoring tools Conduct GCP monitoring visits at investigative sites (PSV, SIV, RMV and COV) Assess CROs and other clinical research vendors Act as primary project contact to external third parties and clinical site teams Support and prepare investigative for potential Regulatory Audits Manage project timelines and critical path activities Help develop, communicate and manage Company standards and appropriate policies and procedures Work with clinical teams to identify and resolve obstacles Establish and nurture positive relations with project sites and team personnel Perform other related duties as assigned Approximately 30-40% travel required (globally) In return, you will bring: Degree or equivalent in health sciences Minimum 5 years direct experience with Phase I - III clinical trials Minimum 5 years of experience in on-site clinical trials monitoring Working knowledge of regulatory requirements (FDA, ICH) including Good Clinical Practice principles and requirements Demonstrated experience managing project teams and third-party contractors Good knowledge of drug development key steps and actors If this sounds like an exciting opportunity to employ your clinical monitoring experience on a small, global team, apply today! 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.","datePosted":"2020-11-17T00:00:00.000Z
Clinical Laboratory Scientist
Club Staffing Cambridge, Massachusetts
Job Description & Requirements Medical Technologist - Clinical Laboratory Scientist - (Med Tech - MT - CLS) StartDate: 01/25/2021Available Shifts: 8 D Pay Rate: $.00 ASCP MT/MLT needed for 13 weeks Required Qualifications ASCP MT/MLT needed for 13 weeks Preferred Qualifications Recent Experience Previous Abbott Architect and Abbott Ruby experience Facility Location Opposite the Charles River from Boston, Cambridge is just a hop away from Massachusetts' most exciting metropolitan area. Cambridge is the home of two of America's most prestigious and famous universities, Harvard and MIT. While residents find themselves in prime position to take advantage of all the cultural and entertainment options in Boston, Cambridge proper offers a wealth of leisure activities, sights and sounds. Culture seekers and history buffs will be delighted by Harvard Art Museum and the Harvard Museum of Natural History, not to mention the many historic buildings that adorn the city's storied streets. Fans of the performing arts can take in a show at one of several theaters in the area, including the Brattle Theatre and The Lily Pad. Outdoors types can visit the city's parks for canoeing, hiking and cycling. Job Benefits Allied travel assignments are typically for 13 weeks and offer generous packages that include: Competitive pay rates Medical, Dental, Vision 401(k) and Flex Spending Life Insurance Accident and Short-term Disability Coverage Free Continuing Education Free Private Housing Refer a friend and earn extra cash! About The Company Club Staffing, an AMN Healthcare company, is the leader in allied healthcare staffing, with thousands of travel positions available throughout the United States. We are dedicated to meeting the unique needs of each allied healthcare professional; whether it's travel, per diem, temp-to-perm, or permanent. We also offer more therapist, laboratory and medical imaging jobs in more places than other travel companies. AMN Healthcare is an EEO/AA/Disability/Protected Veteran Employer. We encourage minority and female applicants to apply. medical technologist, clinical laboratory scientist, medical tech, clinical laboratory technologist, medical laboratory technologist, laboratory, clinical laboratory tech, allied, allied health, cls, mt, med tech
01/17/2021
Full time
Job Description & Requirements Medical Technologist - Clinical Laboratory Scientist - (Med Tech - MT - CLS) StartDate: 01/25/2021Available Shifts: 8 D Pay Rate: $.00 ASCP MT/MLT needed for 13 weeks Required Qualifications ASCP MT/MLT needed for 13 weeks Preferred Qualifications Recent Experience Previous Abbott Architect and Abbott Ruby experience Facility Location Opposite the Charles River from Boston, Cambridge is just a hop away from Massachusetts' most exciting metropolitan area. Cambridge is the home of two of America's most prestigious and famous universities, Harvard and MIT. While residents find themselves in prime position to take advantage of all the cultural and entertainment options in Boston, Cambridge proper offers a wealth of leisure activities, sights and sounds. Culture seekers and history buffs will be delighted by Harvard Art Museum and the Harvard Museum of Natural History, not to mention the many historic buildings that adorn the city's storied streets. Fans of the performing arts can take in a show at one of several theaters in the area, including the Brattle Theatre and The Lily Pad. Outdoors types can visit the city's parks for canoeing, hiking and cycling. Job Benefits Allied travel assignments are typically for 13 weeks and offer generous packages that include: Competitive pay rates Medical, Dental, Vision 401(k) and Flex Spending Life Insurance Accident and Short-term Disability Coverage Free Continuing Education Free Private Housing Refer a friend and earn extra cash! About The Company Club Staffing, an AMN Healthcare company, is the leader in allied healthcare staffing, with thousands of travel positions available throughout the United States. We are dedicated to meeting the unique needs of each allied healthcare professional; whether it's travel, per diem, temp-to-perm, or permanent. We also offer more therapist, laboratory and medical imaging jobs in more places than other travel companies. AMN Healthcare is an EEO/AA/Disability/Protected Veteran Employer. We encourage minority and female applicants to apply. medical technologist, clinical laboratory scientist, medical tech, clinical laboratory technologist, medical laboratory technologist, laboratory, clinical laboratory tech, allied, allied health, cls, mt, med tech
Director/Senior Director, Program Lead
Magenta Therapeutics Cambridge, Massachusetts
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease. Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve. Magenta is seeking highly motivated individuals with a proven track record of success and strategic team leadership to fill key Program Lead (" PL") roles in the cell transplant field for our clinical and near-clinical programs. The PL for our MGTA-117 targeted stem cell conditioning program will lead, along with critical team members, MGTA-117 (e.g. Hematologic Malignancies, gene therapy, and other related diseases), serving effectively as a CEO for the program. The PL will participate in key strategic decisions in support of Magenta's overall business strategy to develop stem cell transplant therapies. The PL for MGTA-117 will be accountable to senior management (e.g., Chief Medical Officer, Chief Scientific Officer, Head of Portfolio and Business) and the senior management team for advancing MGTA-117 and for maximizing the value of projects within his/her areas of responsibility. You are perfect for this role if you are engaged by and want to be responsible for: Driving one or more programs and leading the Program Core Team(s). As collaboration across a matrixed organization is essential for the success of the program, the PL is responsible for ensuring that relevant functions are represented on the Program Core Team and that key stakeholders are kept up to date on relevant information about the program(s). Leading and managing both the preparation and communication of relevant updates of the Project and presenting the Development Strategy and updates to multiple stakeholders including the Executive Leadership Team, Scientific Advisory Board, and the Board of Directors. Ensuring that Clinical Development Plans/Strategy and Regulatory Plans/Strategy are prepared and are aligned with the TPP and the overall Asset Strategy. Assuming ownership of project recommendations between stages of the program to achieve project deliverables and timelines. Conducting continuous project risk assessment and implements appropriate mitigations. Ensuring that deviations from the approved project strategy, timelines or resource allocations are assessed, mitigated and communicated. This includes changes internally or externally leading to new or changed project risks. The PL is accountable for the project budget including projecting/monitoring of current and future cost. Partnering with the Program Core Team in developing project deliverables. The PL is responsible for regular updates to senior management on project progress and for management of project resources. Participating in business development evaluations, as relevant and being actively involved in due diligence. The PL is responsible for ensuring that integration of new projects, in-licensed or partnered, and allocated to the PL, progresses according to plan and risks affecting resources or timelines are assessed and mitigated. This includes ensuring the establishment of optimal working relations with the partner and building a cross-functional Program Team (PT). Presenting the PT endorsed asset strategy and plans for approval at the program's staged reviews We would be thrilled if you brought the following with you: Substantial (10+ years) medical, scientific, and general business experience which should include 3-5 years' experience leading high complexity cross-functional projects; Advanced degree is preferred (e.g. PhD, PharmD, MD) Cellular therapy/hematology/oncology/transplant/immunology experience is preferred Phase I-III experience is required Proven pharmaceutical / biotech cross-functional experience is required. Line management is preferred and cross-national management experience will be ideal Experience working with business development, commercial and medical affairs organizations is preferred; understanding of regional issues from a payer base would be a plus Business planning skills - knowledge/experience with project planning tools and processes Demonstrated ability to effectively develop, communicate and gain support for strategic plans with a wide range of stakeholders Excellent communication skills - experience with either top level biotech/pharma management presentations and fluency in written and spoken English Ability to lead by example and to create high performance teams, building on people's strengths and facilitating the development of team direction promoting open dialogue, collaboration and cross-pollination amongst team members enabling them to rely upon and work well with each other Passionate about drug development; open to change; adaptable Ability to share the team vision while maintaining a link to operational targets Ability to support individuals to improve their current performance and future potential by providing coaching and development opportunities; capable of encouraging business improvement and growth by ensuring staff are positive about change and continuously looking to improve themselves and their work methods Appreciation and understanding of the business benefit of individual differences; ability to deal effectively with people from diverse professional, cultural background Seeks to win support from others within and outside the Company to advance the Company's objectives, using, e.g., reasoning, persuasive arguments, and networking Has good awareness of own strengths, limitations and development needs and applies this to optimize performance and relationships Demonstrated ability to creatively analyze business problems/issues to reach innovative, cost-effective and timely decisions Successful leaders and contributors within Magenta are: Driven . You will be focused on the achievement of Magenta's mission and major corporate goals. Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed. Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company A role model for the company's cultural pillars; Courage, Commitment & Excellence At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together.
01/16/2021
Full time
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease. Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve. Magenta is seeking highly motivated individuals with a proven track record of success and strategic team leadership to fill key Program Lead (" PL") roles in the cell transplant field for our clinical and near-clinical programs. The PL for our MGTA-117 targeted stem cell conditioning program will lead, along with critical team members, MGTA-117 (e.g. Hematologic Malignancies, gene therapy, and other related diseases), serving effectively as a CEO for the program. The PL will participate in key strategic decisions in support of Magenta's overall business strategy to develop stem cell transplant therapies. The PL for MGTA-117 will be accountable to senior management (e.g., Chief Medical Officer, Chief Scientific Officer, Head of Portfolio and Business) and the senior management team for advancing MGTA-117 and for maximizing the value of projects within his/her areas of responsibility. You are perfect for this role if you are engaged by and want to be responsible for: Driving one or more programs and leading the Program Core Team(s). As collaboration across a matrixed organization is essential for the success of the program, the PL is responsible for ensuring that relevant functions are represented on the Program Core Team and that key stakeholders are kept up to date on relevant information about the program(s). Leading and managing both the preparation and communication of relevant updates of the Project and presenting the Development Strategy and updates to multiple stakeholders including the Executive Leadership Team, Scientific Advisory Board, and the Board of Directors. Ensuring that Clinical Development Plans/Strategy and Regulatory Plans/Strategy are prepared and are aligned with the TPP and the overall Asset Strategy. Assuming ownership of project recommendations between stages of the program to achieve project deliverables and timelines. Conducting continuous project risk assessment and implements appropriate mitigations. Ensuring that deviations from the approved project strategy, timelines or resource allocations are assessed, mitigated and communicated. This includes changes internally or externally leading to new or changed project risks. The PL is accountable for the project budget including projecting/monitoring of current and future cost. Partnering with the Program Core Team in developing project deliverables. The PL is responsible for regular updates to senior management on project progress and for management of project resources. Participating in business development evaluations, as relevant and being actively involved in due diligence. The PL is responsible for ensuring that integration of new projects, in-licensed or partnered, and allocated to the PL, progresses according to plan and risks affecting resources or timelines are assessed and mitigated. This includes ensuring the establishment of optimal working relations with the partner and building a cross-functional Program Team (PT). Presenting the PT endorsed asset strategy and plans for approval at the program's staged reviews We would be thrilled if you brought the following with you: Substantial (10+ years) medical, scientific, and general business experience which should include 3-5 years' experience leading high complexity cross-functional projects; Advanced degree is preferred (e.g. PhD, PharmD, MD) Cellular therapy/hematology/oncology/transplant/immunology experience is preferred Phase I-III experience is required Proven pharmaceutical / biotech cross-functional experience is required. Line management is preferred and cross-national management experience will be ideal Experience working with business development, commercial and medical affairs organizations is preferred; understanding of regional issues from a payer base would be a plus Business planning skills - knowledge/experience with project planning tools and processes Demonstrated ability to effectively develop, communicate and gain support for strategic plans with a wide range of stakeholders Excellent communication skills - experience with either top level biotech/pharma management presentations and fluency in written and spoken English Ability to lead by example and to create high performance teams, building on people's strengths and facilitating the development of team direction promoting open dialogue, collaboration and cross-pollination amongst team members enabling them to rely upon and work well with each other Passionate about drug development; open to change; adaptable Ability to share the team vision while maintaining a link to operational targets Ability to support individuals to improve their current performance and future potential by providing coaching and development opportunities; capable of encouraging business improvement and growth by ensuring staff are positive about change and continuously looking to improve themselves and their work methods Appreciation and understanding of the business benefit of individual differences; ability to deal effectively with people from diverse professional, cultural background Seeks to win support from others within and outside the Company to advance the Company's objectives, using, e.g., reasoning, persuasive arguments, and networking Has good awareness of own strengths, limitations and development needs and applies this to optimize performance and relationships Demonstrated ability to creatively analyze business problems/issues to reach innovative, cost-effective and timely decisions Successful leaders and contributors within Magenta are: Driven . You will be focused on the achievement of Magenta's mission and major corporate goals. Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed. Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company A role model for the company's cultural pillars; Courage, Commitment & Excellence At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together.
Laboratory Automation Engineer
Cellarity Cambridge, Massachusetts
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
01/16/2021
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
Business Ethics Monitoring Associate Director, North America
Ipsen Biopharmaceuticals, Inc. Cambridge, Massachusetts
Title: Business Ethics Monitoring Associate Director, North America Company: Ipsen Bioscience, Inc. Job Description: As the Business Ethics Monitoring Associate Director, you will be responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. You will provide compliance advice and support to the company, its subsidiaries and affiliates, perform a variety of investigations, and follow-up on others, through resolution. You enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. Your role will involve: Developing and implementing the monitoring program, with trend reporting on identified risks Leading US Business Ethics Monitoring program across all business units Liaising with Global Business Ethics Monitoring to align on program objectives and share best practices Performing live and transactional monitoring across three business units, as well as Medical Affairs and V&A activities. Reporting monitoring results to business unit heads and other functional senior leaders to inform them of the findings, and work to address and remediate such findings through corrective and preventative action plans. Advising and supporting business units and functional teams in the determination of remediation/CAPAs, their implementation and follow-up Documenting and supporting the implementation of remediation/CAPAs to any monitoring findings Leading US Third Party Due Diligence Program by working with the entire US organization Liaising with Global 3rd Party Compliance Program lead to align on program objectives and share best practices Overseeing implementation of compliance recommendations, including those that result from due diligence findings Leading US compliance investigations with significant remediation efforts to resolution Leading risk assessments, working with the Global Risk team and internal audit to review program compliance, and utilizing analytics to monitor it, identifying areas of risk and prioritize risk mitigation Participating in the US Grants and Charitable Donations Committee as a voting member Leading on implementation of compliance recommendations and documentation/records for commercial programs and initiatives Preparing dispute resolution procedures and advising on process Leading training initiatives, and developing the respective materials within areas of responsibility Creating guidelines and tools, and advising different cross-functional teams to ensure compliance Assisting with other compliance work as needed (may involve international matters) In return, you will bring: Bachelor's degree in related discipline Advanced degree preferred - JD or Graduate Degree 5+ Years Pharmaceutical industry experience required 7+ years of Compliance experience A history that shows an increase in responsibility and complexity (progression in responsibility and level) A demonstrated aptitude and knowledge of the life sciences business model & commercial organization If this sounds like an exciting opportunity to apply your pharmaceutical industry experience in our Global Business Ethics department, apply today! 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.","datePosted":"2020-09-18T00:00:00.000Z
01/16/2021
Full time
Title: Business Ethics Monitoring Associate Director, North America Company: Ipsen Bioscience, Inc. Job Description: As the Business Ethics Monitoring Associate Director, you will be responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. You will provide compliance advice and support to the company, its subsidiaries and affiliates, perform a variety of investigations, and follow-up on others, through resolution. You enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. Your role will involve: Developing and implementing the monitoring program, with trend reporting on identified risks Leading US Business Ethics Monitoring program across all business units Liaising with Global Business Ethics Monitoring to align on program objectives and share best practices Performing live and transactional monitoring across three business units, as well as Medical Affairs and V&A activities. Reporting monitoring results to business unit heads and other functional senior leaders to inform them of the findings, and work to address and remediate such findings through corrective and preventative action plans. Advising and supporting business units and functional teams in the determination of remediation/CAPAs, their implementation and follow-up Documenting and supporting the implementation of remediation/CAPAs to any monitoring findings Leading US Third Party Due Diligence Program by working with the entire US organization Liaising with Global 3rd Party Compliance Program lead to align on program objectives and share best practices Overseeing implementation of compliance recommendations, including those that result from due diligence findings Leading US compliance investigations with significant remediation efforts to resolution Leading risk assessments, working with the Global Risk team and internal audit to review program compliance, and utilizing analytics to monitor it, identifying areas of risk and prioritize risk mitigation Participating in the US Grants and Charitable Donations Committee as a voting member Leading on implementation of compliance recommendations and documentation/records for commercial programs and initiatives Preparing dispute resolution procedures and advising on process Leading training initiatives, and developing the respective materials within areas of responsibility Creating guidelines and tools, and advising different cross-functional teams to ensure compliance Assisting with other compliance work as needed (may involve international matters) In return, you will bring: Bachelor's degree in related discipline Advanced degree preferred - JD or Graduate Degree 5+ Years Pharmaceutical industry experience required 7+ years of Compliance experience A history that shows an increase in responsibility and complexity (progression in responsibility and level) A demonstrated aptitude and knowledge of the life sciences business model & commercial organization If this sounds like an exciting opportunity to apply your pharmaceutical industry experience in our Global Business Ethics department, apply today! 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.","datePosted":"2020-09-18T00:00:00.000Z
Corporate and Securities Paralegal
Intellia Therapeutics Cambridge, Massachusetts
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: 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.
01/15/2021
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases. Job Description: 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.
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