Scientific Editor, Cell Stem Cell Cell Stem Cell is a leading stem cell, biomedical engineering and regenerative medicine journal at Cell Press, and we are seeking a full-time scientific editor to join our close-knit editorial team. We are looking for a dynamic and enthusiastic editor who shares our passion for stem cell science and supporting the research community. This position is open for associate editor and scientific editor, based on experience level. Previous editorial experience is an advantage but is not required. We will provide hands-on training to qualified candidates. Post-doctoral research experience is strongly preferred. JOB DETAILS This is an exciting opportunity to be engaged in shaping and guiding the leading edge of basic and translational stem cell research, as well as an opportunity to facilitate scientific discourse and communication. As a member of the Cell Stem Cell editorial team, you would be responsible for a broad range of contributions to the journal, including recruiting exciting studies; assessing submitted research papers; selecting and collaborating with top notch referees; identifying timely, emerging topics to commission for review articles; writing and editing content for the journal homepage and social media outlets; and engaging authors throughout the review process. The job also entails traveling and virtual visits to scientific conferences and research institutions where you will directly interact with the scientific community and hear about cutting-edge research developments. This is a full-time in-house editorial position and will report to the Editor-in-Chief of Cell Stem Cell. Cell Press is an international organization with primary offices in Cambridge, Massachusetts; London; Amsterdam; and Beijing. The position will be preferably based at the Cell Press office in Cambridge, Massachusetts. We support flexible working, and we are open to considering flexible work arrangements for this position, including hybrid opportunities at other US Elsevier office locations, including New York City and Philadelphia. Cell Press offers an attractive salary and benefits package and a stimulating working environment. Applications will be held in the strictest of confidence. Applications will be considered on a rolling basis until the position is filled. Your application must include a C.V. or resume and cover letter describing your interest in the position and how your skills and knowledge would further scientific communication and contribute to building the journal and advancing its mission. Your responsibilities will include: assessing and discussing the novelty, context and implications of research submitted to Cell Stem Cell selecting and collaborating with referees and recommending well-reasoned editorial decisions based on expert critiques commissioning and editing Reviews, Previews and other commentaries for the journal Engaging with scientists in person and virtually at international conferences and laboratory visits and recruiting exciting studies to the journal Working collaboratively with colleagues at the journal and across Cell Press in a hybrid work environment Organizing scientific conferences and contributing to Cell Press growth and innovation projects. The qualified candidate is expected to have: a Ph.D. and preferably postdoctoral experience, with a strong track record in stem cell research, bioengineering, or a related field within the scope of the journal broad interest in all areas of stem cell biology, both within and beyond your specialty ability to think critically about a wide range of scientific issues and absorb new areas of research strong communication and organizational skills interest in engaging with the scientific community talent for distilling complex concepts and communicating them clearly the ability to work well independently and in a diverse global team. Work in a way that works for you We promote a healthy work/life balance across the organisation. With an average length of service of 9 years, we are confident that we offer an appealing working prospect for our people. With numerous wellbeing initiatives, family leave and tuition reimbursement, we will help you meet your immediate responsibilities and long-term goals. • Working remotely from home or in our office in a flexible hybrid style • Working flexible hours - flexing the times you work in the day Working with us We are an equal opportunity employer with a commitment to help you succeed. Here, you will find an inclusive, agile, collaborative, innovative and fun environment, where everyone has a part to play. Regardless of the team you join, we promote a diverse environment with co-workers who are passionate about what they do, and how they do it. Working for you At Elsevier, we know that your wellbeing and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer: Comprehensive, multi-carrier health plan benefits Disability insurance Dependent Care and Commuter Spending Accounts Life and Accident Insurance Retirement Benefits (Salary Investment Plan/Employer Stock Purchase Plan) Modern Family Benefits, including adoption and surrogacy About Us A global leader in information and analytics, we help researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. Building on our publishing heritage, we combine quality information and vast data sets with analytics to support visionary science and research, health education and interactive learning, as well as exceptional healthcare and clinical practice. At Elsevier, your work contributes to the world's grand challenges and a more sustainable future. We harness innovative technologies to support science and healthcare to partner for a better world. Join Us Are you ready to help us progress science and health? Our technology leads to innovation, so join a forward-thinking digital business that is tackling world-scale challenges and align your ambitions with our passion for driving global knowledge-sharing. The job you are applying for is subject to a COVID-19 vaccination requirement. The successful candidate will be required to submit proof of vaccination. If you are unable to be vaccinated due to a medical condition or a sincerely held religious belief, practice, or observance you should speak to a recruiter about requesting an exemption/accommodation. Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1.. Please read our Candidate Privacy Policy Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1.. Please read our Candidate Privacy Policy Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1.. Please read our Candidate Privacy Policy
06/26/2022
Full time
Scientific Editor, Cell Stem Cell Cell Stem Cell is a leading stem cell, biomedical engineering and regenerative medicine journal at Cell Press, and we are seeking a full-time scientific editor to join our close-knit editorial team. We are looking for a dynamic and enthusiastic editor who shares our passion for stem cell science and supporting the research community. This position is open for associate editor and scientific editor, based on experience level. Previous editorial experience is an advantage but is not required. We will provide hands-on training to qualified candidates. Post-doctoral research experience is strongly preferred. JOB DETAILS This is an exciting opportunity to be engaged in shaping and guiding the leading edge of basic and translational stem cell research, as well as an opportunity to facilitate scientific discourse and communication. As a member of the Cell Stem Cell editorial team, you would be responsible for a broad range of contributions to the journal, including recruiting exciting studies; assessing submitted research papers; selecting and collaborating with top notch referees; identifying timely, emerging topics to commission for review articles; writing and editing content for the journal homepage and social media outlets; and engaging authors throughout the review process. The job also entails traveling and virtual visits to scientific conferences and research institutions where you will directly interact with the scientific community and hear about cutting-edge research developments. This is a full-time in-house editorial position and will report to the Editor-in-Chief of Cell Stem Cell. Cell Press is an international organization with primary offices in Cambridge, Massachusetts; London; Amsterdam; and Beijing. The position will be preferably based at the Cell Press office in Cambridge, Massachusetts. We support flexible working, and we are open to considering flexible work arrangements for this position, including hybrid opportunities at other US Elsevier office locations, including New York City and Philadelphia. Cell Press offers an attractive salary and benefits package and a stimulating working environment. Applications will be held in the strictest of confidence. Applications will be considered on a rolling basis until the position is filled. Your application must include a C.V. or resume and cover letter describing your interest in the position and how your skills and knowledge would further scientific communication and contribute to building the journal and advancing its mission. Your responsibilities will include: assessing and discussing the novelty, context and implications of research submitted to Cell Stem Cell selecting and collaborating with referees and recommending well-reasoned editorial decisions based on expert critiques commissioning and editing Reviews, Previews and other commentaries for the journal Engaging with scientists in person and virtually at international conferences and laboratory visits and recruiting exciting studies to the journal Working collaboratively with colleagues at the journal and across Cell Press in a hybrid work environment Organizing scientific conferences and contributing to Cell Press growth and innovation projects. The qualified candidate is expected to have: a Ph.D. and preferably postdoctoral experience, with a strong track record in stem cell research, bioengineering, or a related field within the scope of the journal broad interest in all areas of stem cell biology, both within and beyond your specialty ability to think critically about a wide range of scientific issues and absorb new areas of research strong communication and organizational skills interest in engaging with the scientific community talent for distilling complex concepts and communicating them clearly the ability to work well independently and in a diverse global team. Work in a way that works for you We promote a healthy work/life balance across the organisation. With an average length of service of 9 years, we are confident that we offer an appealing working prospect for our people. With numerous wellbeing initiatives, family leave and tuition reimbursement, we will help you meet your immediate responsibilities and long-term goals. • Working remotely from home or in our office in a flexible hybrid style • Working flexible hours - flexing the times you work in the day Working with us We are an equal opportunity employer with a commitment to help you succeed. Here, you will find an inclusive, agile, collaborative, innovative and fun environment, where everyone has a part to play. Regardless of the team you join, we promote a diverse environment with co-workers who are passionate about what they do, and how they do it. Working for you At Elsevier, we know that your wellbeing and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer: Comprehensive, multi-carrier health plan benefits Disability insurance Dependent Care and Commuter Spending Accounts Life and Accident Insurance Retirement Benefits (Salary Investment Plan/Employer Stock Purchase Plan) Modern Family Benefits, including adoption and surrogacy About Us A global leader in information and analytics, we help researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. Building on our publishing heritage, we combine quality information and vast data sets with analytics to support visionary science and research, health education and interactive learning, as well as exceptional healthcare and clinical practice. At Elsevier, your work contributes to the world's grand challenges and a more sustainable future. We harness innovative technologies to support science and healthcare to partner for a better world. Join Us Are you ready to help us progress science and health? Our technology leads to innovation, so join a forward-thinking digital business that is tackling world-scale challenges and align your ambitions with our passion for driving global knowledge-sharing. The job you are applying for is subject to a COVID-19 vaccination requirement. The successful candidate will be required to submit proof of vaccination. If you are unable to be vaccinated due to a medical condition or a sincerely held religious belief, practice, or observance you should speak to a recruiter about requesting an exemption/accommodation. Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1.. Please read our Candidate Privacy Policy Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1.. Please read our Candidate Privacy Policy Elsevier is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1.. Please read our Candidate Privacy Policy
The Hollister Group, Inc.
Cambridge, Massachusetts
Administrative & HR Direct Hire Cambridge, MA Job Number: JO-241 Assistant Property Manager A Boston-based commercial real estate firm is looking to hire an Assistant Property Manager to manage the timely completion of day-to-day operational issues at an assigned property. The individual in this role will serve as a tenant liaison, focusing on maintaining a high level of tenant satisfaction. If you are interested in this opportunity and would like to be considered, please submit a copy of your resume today! Responsibilities: Build and maintain relationships with tenants Assist Property Manager with the development of RFPs and execution of contracts and purchase orders Receive incoming requests for services and assign tasks by priority to the appropriate department Facilitate various building work projects such as addressing utility services issues, coordinating maintenance work, repairs, and other property enhancements to minimize inconvenience to tenants Provide positive direction to building staff and vendors to ensure delivery of quality products and service Interact with all levels of management, office staff and field personnel, as well as vendors and contractors Qualifications: Bachelor's degree required 2-5 years of property management experience, preferably in commercial property management Ability to follow through on work assignments in a timely and organized manner Customer relations skills in interacting with all levels of management and field personnel Strong problem-solving and negotiating skills required Excellent verbal and written communication skills Our Commitment to Diversity, Equity & Inclusion The Hollister Group is an equal opportunity employer. We welcome and encourage applications from people who are under-represented in their respective occupation or position.
06/26/2022
Full time
Administrative & HR Direct Hire Cambridge, MA Job Number: JO-241 Assistant Property Manager A Boston-based commercial real estate firm is looking to hire an Assistant Property Manager to manage the timely completion of day-to-day operational issues at an assigned property. The individual in this role will serve as a tenant liaison, focusing on maintaining a high level of tenant satisfaction. If you are interested in this opportunity and would like to be considered, please submit a copy of your resume today! Responsibilities: Build and maintain relationships with tenants Assist Property Manager with the development of RFPs and execution of contracts and purchase orders Receive incoming requests for services and assign tasks by priority to the appropriate department Facilitate various building work projects such as addressing utility services issues, coordinating maintenance work, repairs, and other property enhancements to minimize inconvenience to tenants Provide positive direction to building staff and vendors to ensure delivery of quality products and service Interact with all levels of management, office staff and field personnel, as well as vendors and contractors Qualifications: Bachelor's degree required 2-5 years of property management experience, preferably in commercial property management Ability to follow through on work assignments in a timely and organized manner Customer relations skills in interacting with all levels of management and field personnel Strong problem-solving and negotiating skills required Excellent verbal and written communication skills Our Commitment to Diversity, Equity & Inclusion The Hollister Group is an equal opportunity employer. We welcome and encourage applications from people who are under-represented in their respective occupation or position.
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Key Responsibilities & Accountabilities: Assist with the establishment and maintenance of mouse tumor models to test the efficacy and MOA of cellular cancer therapies Perform mouse in vivo animal procedures, including tumor inoculation and dosing mice by various routes (IP, IV, SC, etc.), serial blood collections, tissue harvesting at necropsy, and data collection Monitor in-life study measurements: measure tumors by calipers and non-invasive bioluminescent imaging (IVIS), body weights, make detailed observations of tumor growth and mouse health Perform cell culture, including passaging, expanding, cryopreservation, thawing and processing of tumor cells Organization of studies: timing of in vitro tumor culturing, tumor implantation, randomization, and handling/processing cellular therapies for dosing Experience with multi-parameter flow cytometry (FACS) analysis is preferred Share responsibilities in maintaining lab equipment and reagent inventory Follow laboratory safety guidelines and practices Analyze data and effectively communicate experimental results to research scientists Maintain a meticulous electronic lab notebook and contribute to support documentation Requirements Knowledge, Skills & Capabilities: Expertise in asceptic cell culture is preferred Experience in direct mouse handling and performing pharmacology related tasks including dosing, survival blood collections, tumor cell inoculation/measurements, tissue harvesting at necropsy, etc. Independently motivated, detail oriented and excellent problem-solver Ability to work with cross-functional teams in a fast-paced environment Education & Relevant Work Experience: BS/MS in Biology or related discipline. 2+ years of relevant research experience in an academic or pharmaceutical/biotech vivarium. Background in immuno-oncology is preferred
06/26/2022
Full time
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Key Responsibilities & Accountabilities: Assist with the establishment and maintenance of mouse tumor models to test the efficacy and MOA of cellular cancer therapies Perform mouse in vivo animal procedures, including tumor inoculation and dosing mice by various routes (IP, IV, SC, etc.), serial blood collections, tissue harvesting at necropsy, and data collection Monitor in-life study measurements: measure tumors by calipers and non-invasive bioluminescent imaging (IVIS), body weights, make detailed observations of tumor growth and mouse health Perform cell culture, including passaging, expanding, cryopreservation, thawing and processing of tumor cells Organization of studies: timing of in vitro tumor culturing, tumor implantation, randomization, and handling/processing cellular therapies for dosing Experience with multi-parameter flow cytometry (FACS) analysis is preferred Share responsibilities in maintaining lab equipment and reagent inventory Follow laboratory safety guidelines and practices Analyze data and effectively communicate experimental results to research scientists Maintain a meticulous electronic lab notebook and contribute to support documentation Requirements Knowledge, Skills & Capabilities: Expertise in asceptic cell culture is preferred Experience in direct mouse handling and performing pharmacology related tasks including dosing, survival blood collections, tumor cell inoculation/measurements, tissue harvesting at necropsy, etc. Independently motivated, detail oriented and excellent problem-solver Ability to work with cross-functional teams in a fast-paced environment Education & Relevant Work Experience: BS/MS in Biology or related discipline. 2+ years of relevant research experience in an academic or pharmaceutical/biotech vivarium. Background in immuno-oncology is preferred
Cashiers are the first to greet customers and the last to thank them. They are the face of Rural King and are expected to provide outstanding customer service and to exceed the customer's expectations. They must provide this exceptional service through communication, friendliness, accurate transactions, and store/product knowledge. Rural King Cashiers also maintain a clean and inviting front end of the store. Provide customers with outstanding customer service. Communicate professionally and in an upbeat and friendly manner with all Rural King associates and customers. Greet customers with a smile and positive attitude. Perform accurate transactions in a timely manner. Execute cash management, return, and exchange policies accurately. Encourage the purchase of promotional items. Clean front windows and registers. Be alert to surroundings for shrink prevention and customer service. Always look for product that could be hidden by the customer. Keep popcorn and coffee full and fresh. Offer loadout assistance to customers and follow up to ensure a loader has responded. Answer incoming calls at the registers with proper phone etiquette that includes being calm, professional, and friendly. Help drive company initiatives, such as Rural King's Harvest Card Program, Customer C.A.R.E., and RK Plus Protection Plan. Use general office equipment. Ability to use point-of-sale system to complete transactions. Frequently operate keyboard to enter in information. Ability to sit/stand/walk for long periods of time. Ability to verbally communicate effectively with customers and co-workers (in-person and via electronic devices). Ability to move up to 20 pounds repetitively and 21-50 pounds intermittently. May be required to cross train and perform other duties. SUPERVISORY RESPONSIBILITIES None. Have great people skills and desire to help others. Ability to interact with the team in a fast-paced environment, remaining flexible, proactive, resourceful and efficient. Ability to problem solve and be proactive. Ability to complete repetitive tasks. Ability to access and use the in-store computer, scanning system, and wireless handheld unit. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job
06/26/2022
Full time
Cashiers are the first to greet customers and the last to thank them. They are the face of Rural King and are expected to provide outstanding customer service and to exceed the customer's expectations. They must provide this exceptional service through communication, friendliness, accurate transactions, and store/product knowledge. Rural King Cashiers also maintain a clean and inviting front end of the store. Provide customers with outstanding customer service. Communicate professionally and in an upbeat and friendly manner with all Rural King associates and customers. Greet customers with a smile and positive attitude. Perform accurate transactions in a timely manner. Execute cash management, return, and exchange policies accurately. Encourage the purchase of promotional items. Clean front windows and registers. Be alert to surroundings for shrink prevention and customer service. Always look for product that could be hidden by the customer. Keep popcorn and coffee full and fresh. Offer loadout assistance to customers and follow up to ensure a loader has responded. Answer incoming calls at the registers with proper phone etiquette that includes being calm, professional, and friendly. Help drive company initiatives, such as Rural King's Harvest Card Program, Customer C.A.R.E., and RK Plus Protection Plan. Use general office equipment. Ability to use point-of-sale system to complete transactions. Frequently operate keyboard to enter in information. Ability to sit/stand/walk for long periods of time. Ability to verbally communicate effectively with customers and co-workers (in-person and via electronic devices). Ability to move up to 20 pounds repetitively and 21-50 pounds intermittently. May be required to cross train and perform other duties. SUPERVISORY RESPONSIBILITIES None. Have great people skills and desire to help others. Ability to interact with the team in a fast-paced environment, remaining flexible, proactive, resourceful and efficient. Ability to problem solve and be proactive. Ability to complete repetitive tasks. Ability to access and use the in-store computer, scanning system, and wireless handheld unit. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job
About the Opportunity The Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Genzyme Global Business Unit (GBU). He/she is responsible for developing long and short-term regulatory strategies for the projects and products under his/her accountability. The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products. Major Activities/Key Responsibilities ? Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s). The GRTL will ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS) The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries. The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed. The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels. The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed. Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate. The GRTL may line manage, and/or coach mentor, junior staff supporting the program Depending on the program assignment, the GRTL may also serve as the US Regulatory Lead. Impact on the organization A robust regulatory strategy, whether for projects on the market (Commercial) or these in development, is critical for the success of the business and for the company to meet its goals. Experience/Professional Requirement Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions. Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance Excellent operational skills including planning, organizing and ability to motivate and lead others. Ability to work well within cross-functional teams Can demonstrate solid oral communication and writing skills Understanding of the Global (including US, EU in Japan in particular) and U.S. pharmaceutical marketplace and familiarity with medical terminology. Develops collaborative relationships to facilitate the accomplishment of work goals Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans Can build networks to obtain cooperation without relying on authority Strong sensitivity for a multicultural/multinational environment Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values Ideal Background (state preferred education and experience level) Education Bachelor's degree and at least 8 years in Regulatory Affairs or relevant industry experience Master's, PharmD, PhD degree and at least 6 years in Regulatory Affairs or relevant industry experience Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus. Languages: English This is our Sanofi. Discover yours. At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
06/26/2022
Full time
About the Opportunity The Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Genzyme Global Business Unit (GBU). He/she is responsible for developing long and short-term regulatory strategies for the projects and products under his/her accountability. The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products. Major Activities/Key Responsibilities ? Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s). The GRTL will ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS) The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries. The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed. The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels. The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed. Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate. The GRTL may line manage, and/or coach mentor, junior staff supporting the program Depending on the program assignment, the GRTL may also serve as the US Regulatory Lead. Impact on the organization A robust regulatory strategy, whether for projects on the market (Commercial) or these in development, is critical for the success of the business and for the company to meet its goals. Experience/Professional Requirement Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions. Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance Excellent operational skills including planning, organizing and ability to motivate and lead others. Ability to work well within cross-functional teams Can demonstrate solid oral communication and writing skills Understanding of the Global (including US, EU in Japan in particular) and U.S. pharmaceutical marketplace and familiarity with medical terminology. Develops collaborative relationships to facilitate the accomplishment of work goals Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans Can build networks to obtain cooperation without relying on authority Strong sensitivity for a multicultural/multinational environment Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values Ideal Background (state preferred education and experience level) Education Bachelor's degree and at least 8 years in Regulatory Affairs or relevant industry experience Master's, PharmD, PhD degree and at least 6 years in Regulatory Affairs or relevant industry experience Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus. Languages: English This is our Sanofi. Discover yours. At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Company: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 02367 Minimum Level of Education: Associate's Degree Employment Type: Full Time Travel Percentage: Up to 25% SIGN ON BONUS UP TO $10,000 Job Summary: We are seeking experienced CDL Training Manager to join our Operations Academy that can lead the development of a standardized training curriculum, and facilitate the deployment of this curriculum nationwide. These managers would spend their time developing and deploying a standardized curriculum that adheres to state specific requirements and provide hands on advanced training to students that would enable them to pass a state specific CDL exam. Duties and Responsibilities: Development of a standardized training curriculum that can be deployed nationally that adheres to state specific requirements Leads the facilitation and deployment of CDL A training curriculum. Provides advanced hands-on technical training in advanced applications, maneuvers, testing preparation activities and state specific vehicle inspections. Additionally, will provide training in prescribed engineered work methods and best practices associated with commercial vehicle training enabling students to meet or exceed requirements needed to successfully pass the Class A Commercial Driver's Test. Evaluate and test candidates for progress during stages of training, skills of new candidates when needed. Maintain all documentation, tracking, evaluations and attendance Education Required: Associates Degree Education Preferred: Bachelors Degree Experience Required: Candidates must have 5 years minimum Class A commercial vehicle experience Candidates should have experience in training, instruction and evaluation methods Candidates should have experience with curriculum development and standardization Must be physically able to operate motor vehicles. Be patient and a good leader towards students. Demonstrate empathy towards students during training, making a positive impact in their lives. Experience Preferred: Associates degree required, bachelors degree preferred. Able to use Microsoft Office Suite Previous Certified CDL Instructor or Examiner a plus Bring a strong work ethic, self-motivation, and problem solving skills. A strong desire to succeed and getting it done right. Licenses/Certification Required: Must hold a valid Class A Commercial Driver's License and have a good driving record. Valid Medical Card, Clean MVR Report a plus. Licenses/Certification Preferred: Smith System Certified Physical Demands: Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of this job. Working outside in many types weather conditions. Working on your feet for several hours, Climbing, sitting, bending in and around vehicle equipment. Travel Requirements: Able to travel to another school location out of state for short periods a plus. Work Environment: Warehouse and Trucking Site, loud noises, Osha safety, vehicle safety area. BENEFITS INFORMATION: For information on Sysco's Benefits, please visit HOW WE PROTECT OUR ASSOCIATES COVID-19 Precaution(s): Personal protective equipment and masks provided Temperature screenings Social distancing guidelines in place Sanitizing, disinfecting, and cleaning procedures in place OVERVIEW: Sysco is the global leader in foodservice distribution. With over 57,000 associates and a fleet of over 13,000 vehicles, Sysco operates approximately 326 distribution facilities worldwide and serves more than 625,000 customer locations. We offer our associates the opportunity to grow personally and professionally, to contribute to the success of a dynamic organization, and to serve others in a manner that exceeds their expectations. We're looking for talented, hard-working individuals to join our team. Come grow with us and let us show you why Sysco is at the heart of food and service. AFFIRMATIVE ACTION STATEMENT: Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.
06/26/2022
Full time
Company: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 02367 Minimum Level of Education: Associate's Degree Employment Type: Full Time Travel Percentage: Up to 25% SIGN ON BONUS UP TO $10,000 Job Summary: We are seeking experienced CDL Training Manager to join our Operations Academy that can lead the development of a standardized training curriculum, and facilitate the deployment of this curriculum nationwide. These managers would spend their time developing and deploying a standardized curriculum that adheres to state specific requirements and provide hands on advanced training to students that would enable them to pass a state specific CDL exam. Duties and Responsibilities: Development of a standardized training curriculum that can be deployed nationally that adheres to state specific requirements Leads the facilitation and deployment of CDL A training curriculum. Provides advanced hands-on technical training in advanced applications, maneuvers, testing preparation activities and state specific vehicle inspections. Additionally, will provide training in prescribed engineered work methods and best practices associated with commercial vehicle training enabling students to meet or exceed requirements needed to successfully pass the Class A Commercial Driver's Test. Evaluate and test candidates for progress during stages of training, skills of new candidates when needed. Maintain all documentation, tracking, evaluations and attendance Education Required: Associates Degree Education Preferred: Bachelors Degree Experience Required: Candidates must have 5 years minimum Class A commercial vehicle experience Candidates should have experience in training, instruction and evaluation methods Candidates should have experience with curriculum development and standardization Must be physically able to operate motor vehicles. Be patient and a good leader towards students. Demonstrate empathy towards students during training, making a positive impact in their lives. Experience Preferred: Associates degree required, bachelors degree preferred. Able to use Microsoft Office Suite Previous Certified CDL Instructor or Examiner a plus Bring a strong work ethic, self-motivation, and problem solving skills. A strong desire to succeed and getting it done right. Licenses/Certification Required: Must hold a valid Class A Commercial Driver's License and have a good driving record. Valid Medical Card, Clean MVR Report a plus. Licenses/Certification Preferred: Smith System Certified Physical Demands: Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of this job. Working outside in many types weather conditions. Working on your feet for several hours, Climbing, sitting, bending in and around vehicle equipment. Travel Requirements: Able to travel to another school location out of state for short periods a plus. Work Environment: Warehouse and Trucking Site, loud noises, Osha safety, vehicle safety area. BENEFITS INFORMATION: For information on Sysco's Benefits, please visit HOW WE PROTECT OUR ASSOCIATES COVID-19 Precaution(s): Personal protective equipment and masks provided Temperature screenings Social distancing guidelines in place Sanitizing, disinfecting, and cleaning procedures in place OVERVIEW: Sysco is the global leader in foodservice distribution. With over 57,000 associates and a fleet of over 13,000 vehicles, Sysco operates approximately 326 distribution facilities worldwide and serves more than 625,000 customer locations. We offer our associates the opportunity to grow personally and professionally, to contribute to the success of a dynamic organization, and to serve others in a manner that exceeds their expectations. We're looking for talented, hard-working individuals to join our team. Come grow with us and let us show you why Sysco is at the heart of food and service. AFFIRMATIVE ACTION STATEMENT: Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.
Senior Associate Scientist/Principal Associate Scientist - Nucleic Acid Process Development This company is an innovative genetic medicines company focused on creating a new class of non-viral gene therapy to provide durable, redosable treatments for people living with rare and prevalent diseases. The company's non-viral platform incorporates a proprietary, high-capacity DNA construct called closed-ended DNA, or ceDNA; a cell-targeted lipid nanoparticle delivery system, or ctLNP; and an established, scalable capsid-free manufacturing process. The platform is designed to enable multi-year durability from a single dose of ceDNA and to allow titration and redosing if needed, and our scalable manufacturing process supports our mission to extend the reach of gene therapy to more people, living with more diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today. We are a thriving, collaborative, creative community of 120 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts. RESPONSIBILITIES: Primary responsibilities for this role include: Exploring efforts focused on high yielding nucleic acid amplification methods Optimizing and advancing the enzymatic synthesis and manipulation of DNA Supporting the development of next generation nucleic acid production efforts through process engineering and identification of technologies to improve production performance Preparing, analyzing, and presenting data internally to cross functional teams Completing all appropriate documentation such as protocols, reports, IND enabling documents, etc. QUALIFICATIONS: Degree in Molecular Biology, Bioengineering, Biochemistry or equivalent. 0-2 years (PhD), 5 years (MS), or 7 years (BS) of relevant experience; title flexibility possible based on years of experience Understanding of enzyme characterization and biochemical reaction optimization Sense of urgency, results-driven, and excellent attention to detail Proven ability to work independently, effectively plan work activities, and prioritize task completion to meet schedules and deadlines Strong collaboration and team-working skills Desired experience: Familiarity with enzyme driven bioproduction processes Strong understanding of nucleic acid amplification methods and quantitative assays Expertise with the development of scalable and commercially viable processes in biotech/pharma/food industry Knowledge of cGMP and regulatory guidelines and practices, and how these relate to and impact process development EOE Statement: Specialist Staffing Group 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 veteran status. To find out more about Real please visit
06/26/2022
Full time
Senior Associate Scientist/Principal Associate Scientist - Nucleic Acid Process Development This company is an innovative genetic medicines company focused on creating a new class of non-viral gene therapy to provide durable, redosable treatments for people living with rare and prevalent diseases. The company's non-viral platform incorporates a proprietary, high-capacity DNA construct called closed-ended DNA, or ceDNA; a cell-targeted lipid nanoparticle delivery system, or ctLNP; and an established, scalable capsid-free manufacturing process. The platform is designed to enable multi-year durability from a single dose of ceDNA and to allow titration and redosing if needed, and our scalable manufacturing process supports our mission to extend the reach of gene therapy to more people, living with more diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today. We are a thriving, collaborative, creative community of 120 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts. RESPONSIBILITIES: Primary responsibilities for this role include: Exploring efforts focused on high yielding nucleic acid amplification methods Optimizing and advancing the enzymatic synthesis and manipulation of DNA Supporting the development of next generation nucleic acid production efforts through process engineering and identification of technologies to improve production performance Preparing, analyzing, and presenting data internally to cross functional teams Completing all appropriate documentation such as protocols, reports, IND enabling documents, etc. QUALIFICATIONS: Degree in Molecular Biology, Bioengineering, Biochemistry or equivalent. 0-2 years (PhD), 5 years (MS), or 7 years (BS) of relevant experience; title flexibility possible based on years of experience Understanding of enzyme characterization and biochemical reaction optimization Sense of urgency, results-driven, and excellent attention to detail Proven ability to work independently, effectively plan work activities, and prioritize task completion to meet schedules and deadlines Strong collaboration and team-working skills Desired experience: Familiarity with enzyme driven bioproduction processes Strong understanding of nucleic acid amplification methods and quantitative assays Expertise with the development of scalable and commercially viable processes in biotech/pharma/food industry Knowledge of cGMP and regulatory guidelines and practices, and how these relate to and impact process development EOE Statement: Specialist Staffing Group 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 veteran status. To find out more about Real please visit
The company ReviveMed is an MIT spinout that created the world's most advanced AI platform and a proprietary database with the highest quality and density of metabolite data. While current methods are limited to a few hundred metabolite data points at the most, ReviveMed uses data from 10,000+ metabolites. As a result, in a fraction of the time and cost, we have discovered therapeutic assets for four diseases internally, including NASH and renal cell carcinoma, and in strategic collaboration with big pharma, with a combined therapeutic market value of >$50B. Over the next five years, ReviveMed is poised to revolutionize the drug discovery market by collecting data from 50 more diseases and creating billions in therapeutic value. We are located in the heart of biotech innovation in Cambridge, MA. We are looking for candidates who work in the office, and also consider strong candidates who would prefer to work remotely. We are an award-winning enthusiastic team, passionate about innovative, data-driven approaches to bringing the right therapeutics to the right patients, and ultimately saving millions of lives. Responsibilities: Research and apply the latest machine learning and deep learning methodologies to address drug discovery problems prototype and build data processing pipelines and deep learning algorithms for biochemical data leverage open source deep learning models and transfer learning to reduce time to solution Speed up training of large deep learning models using clusters of CPUs and GPUs Develop optimized data pipelines to fuel deep learning models Develop tools to assist data processing, data quality control, algorithm development, algorithm testing, and deployment Communicate findings to a multi-disciplinary audience Qualifications Ph.D. in Computer Science or related fields; 3+ years of work experience preferred Extensive experience in leveraging Deep Learning ( ANN, CNN, RNN, Auto-encoders, GAN, etc.) Strong understanding of the underlying math and learning concepts in these algorithms Proficiency in Python, and familiarity with deep learning frameworks (e.g., TensorFlow, Keras, PyTorch, etc.) and deep learning hardware (CPU, GPU, multi-node) Self-motivated, highly disciplined, passionate about learning, and making a change in the world Why you should join ReviveMed An opportunity to learn about the applications of advanced artificial intelligence algorithms to drug discovery and development from the beginning Opportunities for personal and professional growth as our company expands Competitive compensation, health insurance, as well as share options Making an impact on the world with every line of code
06/26/2022
Full time
The company ReviveMed is an MIT spinout that created the world's most advanced AI platform and a proprietary database with the highest quality and density of metabolite data. While current methods are limited to a few hundred metabolite data points at the most, ReviveMed uses data from 10,000+ metabolites. As a result, in a fraction of the time and cost, we have discovered therapeutic assets for four diseases internally, including NASH and renal cell carcinoma, and in strategic collaboration with big pharma, with a combined therapeutic market value of >$50B. Over the next five years, ReviveMed is poised to revolutionize the drug discovery market by collecting data from 50 more diseases and creating billions in therapeutic value. We are located in the heart of biotech innovation in Cambridge, MA. We are looking for candidates who work in the office, and also consider strong candidates who would prefer to work remotely. We are an award-winning enthusiastic team, passionate about innovative, data-driven approaches to bringing the right therapeutics to the right patients, and ultimately saving millions of lives. Responsibilities: Research and apply the latest machine learning and deep learning methodologies to address drug discovery problems prototype and build data processing pipelines and deep learning algorithms for biochemical data leverage open source deep learning models and transfer learning to reduce time to solution Speed up training of large deep learning models using clusters of CPUs and GPUs Develop optimized data pipelines to fuel deep learning models Develop tools to assist data processing, data quality control, algorithm development, algorithm testing, and deployment Communicate findings to a multi-disciplinary audience Qualifications Ph.D. in Computer Science or related fields; 3+ years of work experience preferred Extensive experience in leveraging Deep Learning ( ANN, CNN, RNN, Auto-encoders, GAN, etc.) Strong understanding of the underlying math and learning concepts in these algorithms Proficiency in Python, and familiarity with deep learning frameworks (e.g., TensorFlow, Keras, PyTorch, etc.) and deep learning hardware (CPU, GPU, multi-node) Self-motivated, highly disciplined, passionate about learning, and making a change in the world Why you should join ReviveMed An opportunity to learn about the applications of advanced artificial intelligence algorithms to drug discovery and development from the beginning Opportunities for personal and professional growth as our company expands Competitive compensation, health insurance, as well as share options Making an impact on the world with every line of code
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Editas is seeking a Quality Control Senior Analyst to join the Quality Control team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible for Method Transfer from Internal Analytic Development and/or External Testing Laboratories to Editas Quality Control at Editas Medicine. This position will be also responsible for performing a variety of QC testing including, but not limited to, using Flow Cytometry, FTIR, Osmometer, Cellometer, NanoDrop, ImageStream, UV-VIS, HPLC/UHPLC, PCR, Plate-reader, pH/Conductivity, Gel Electrophoresis and Compendial Methods. This position will work at both QC sites in Cambridge facility and Waltham facility, MA. Key Responsibilities & Accountabilities: Responsible for drafting, executing and reporting Method Transfer Protocols. Method tranfer is included, but not limited to, all release tests for Editas RNP and RNP buffer, and other drug substance and products. Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA, HPLC/UHPLC, qPCR, ImageStream Analysis, etc. Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required. Responsible for change controls, OOS and deviations, as required. Communicates with internal analysts in QC and different departments in Editas, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving. Perform other duties, as assigned. Requirements Knowledge, Experience, Skills & Capabilities: Working experience on method transfer. Hands-on experience minimanly on following equipment/assays, but not limited to: Visual Appearance Inspection, pH, Osmolality, Subvisible Particle, K2 cellometer, NanoDrop, ELISA, HPLC/UHPLC, qPCR. Working experience in analytical/QC environment. Working experience in compliance with cGMP's, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities. Ability to work independently with skills for multi tests/projects. Ability to collaborate, communicate, and work effectively in a team-oriented. Good verbal and written communication skills. Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Traning systems. Education & Relevant Work Experience: Bachelor's or Master's degree in biology, chemistry or other life science. At least 5-8 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus. Authorization to work in the United States indefinitely without restriction or sponsorship.
06/26/2022
Full time
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Editas is seeking a Quality Control Senior Analyst to join the Quality Control team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible for Method Transfer from Internal Analytic Development and/or External Testing Laboratories to Editas Quality Control at Editas Medicine. This position will be also responsible for performing a variety of QC testing including, but not limited to, using Flow Cytometry, FTIR, Osmometer, Cellometer, NanoDrop, ImageStream, UV-VIS, HPLC/UHPLC, PCR, Plate-reader, pH/Conductivity, Gel Electrophoresis and Compendial Methods. This position will work at both QC sites in Cambridge facility and Waltham facility, MA. Key Responsibilities & Accountabilities: Responsible for drafting, executing and reporting Method Transfer Protocols. Method tranfer is included, but not limited to, all release tests for Editas RNP and RNP buffer, and other drug substance and products. Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA, HPLC/UHPLC, qPCR, ImageStream Analysis, etc. Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required. Responsible for change controls, OOS and deviations, as required. Communicates with internal analysts in QC and different departments in Editas, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving. Perform other duties, as assigned. Requirements Knowledge, Experience, Skills & Capabilities: Working experience on method transfer. Hands-on experience minimanly on following equipment/assays, but not limited to: Visual Appearance Inspection, pH, Osmolality, Subvisible Particle, K2 cellometer, NanoDrop, ELISA, HPLC/UHPLC, qPCR. Working experience in analytical/QC environment. Working experience in compliance with cGMP's, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities. Ability to work independently with skills for multi tests/projects. Ability to collaborate, communicate, and work effectively in a team-oriented. Good verbal and written communication skills. Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Traning systems. Education & Relevant Work Experience: Bachelor's or Master's degree in biology, chemistry or other life science. At least 5-8 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus. Authorization to work in the United States indefinitely without restriction or sponsorship.
Location: Boston, MA Department: Analytical Development Position Overview: Seeking a talented employee to join our Analytical Development group in Boston, MA. Consistently and passionately challenging the boundaries of their knowledge, our Analytical Development team employs traditional and innovative analytical techniques and Quality-by-Design principles to develop and validate the analytical tools used to ensure the safety, efficacy and quality of our companies pharmaceutical products. As a member of the Analytical Development team, this role will support the drug development programs at our company through dissolution testing and dissolution method development. The ideal candidate will have proven experience in dissolution testing with the ability to excel in a fast paced environment. Key Responsibilities: - Develops, troubleshoots and conducts dissolution experiments in support of drug product process development - Performs dissolution stability testing on drug products - Maintains accurate records of experiments and results in an electronic laboratory notebook and authors reports as assigned - Designs, executes, and interprets experiments with a high degree of reliability and independence - Performs basic statistical analysis of experimental data, where appropriate - Maintains general lab equipment, including HPLCs and dissolution systems. - Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations - Performs other duties as assigned Minimum Qualifications: - A Bachelor's degree degree in Chemistry, Chemical Engineering or Pharmaceutical Chemistry and 0-2 years relevant analytical experience - Knowledge of HPLC and dissolution testing is required - Excellent experimental documentation is required Preferred Qualifications: - A basic knowledge of cGMPs is required - Dissolution experience across multiple systems (manual, semi-automated and automated dissolution systems) - Experience with biorelevant dissolution testing - The ability to work successfully in both a team/matrix environment as well as independently - The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects EOE Statement: Specialist Staffing Group 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 veteran status. To find out more about Real please visit
06/26/2022
Full time
Location: Boston, MA Department: Analytical Development Position Overview: Seeking a talented employee to join our Analytical Development group in Boston, MA. Consistently and passionately challenging the boundaries of their knowledge, our Analytical Development team employs traditional and innovative analytical techniques and Quality-by-Design principles to develop and validate the analytical tools used to ensure the safety, efficacy and quality of our companies pharmaceutical products. As a member of the Analytical Development team, this role will support the drug development programs at our company through dissolution testing and dissolution method development. The ideal candidate will have proven experience in dissolution testing with the ability to excel in a fast paced environment. Key Responsibilities: - Develops, troubleshoots and conducts dissolution experiments in support of drug product process development - Performs dissolution stability testing on drug products - Maintains accurate records of experiments and results in an electronic laboratory notebook and authors reports as assigned - Designs, executes, and interprets experiments with a high degree of reliability and independence - Performs basic statistical analysis of experimental data, where appropriate - Maintains general lab equipment, including HPLCs and dissolution systems. - Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations - Performs other duties as assigned Minimum Qualifications: - A Bachelor's degree degree in Chemistry, Chemical Engineering or Pharmaceutical Chemistry and 0-2 years relevant analytical experience - Knowledge of HPLC and dissolution testing is required - Excellent experimental documentation is required Preferred Qualifications: - A basic knowledge of cGMPs is required - Dissolution experience across multiple systems (manual, semi-automated and automated dissolution systems) - Experience with biorelevant dissolution testing - The ability to work successfully in both a team/matrix environment as well as independently - The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects EOE Statement: Specialist Staffing Group 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 veteran status. To find out more about Real please visit
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Editas is seeking a Quality Control Analyst II to join the Quality Control team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible for Method Transfer from Internal Analytic Development and/or External Testing Laboratories to Editas Quality Control at Editas Medicine. This position will be also responsible for performing a variety of QC testing including, but not limited to, using Flow Cytometry, FTIR, Osmometer, Cellometer, NanoDrop, ImageStream, UV-VIS, HPLC/UHPLC, PCR, Plate-reader, pH/Conductivity, Gel Electrophoresis and Compendial Methods. This position will work at both QC sites in Cambridge facility and Waltham facility, MA. Key Responsibilities & Accountabilities: Responsible for drafting, executing and reporting Method Transfer Protocols. Method tranfer is included, but not limited to, all release tests for Editas RNP and RNP buffer, and other drug substance and products. Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA, HPLC/UHPLC, qPCR, ImageStream Analysis, etc. Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required. Responsible for change controls, OOS and deviations, as required. Communicates with internal analysts in QC and different departments in Editas, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving. Perform other duties, as assigned. Requirements Knowledge, Experience, Skills & Capabilities: Working experience on method transfer. Hands-on experience minimally on following equipment/assays, but not limited to: Visual Appearance Inspection, pH, Osmolality, Subvisible Particle, K2 cellometer, NanoDrop, ELISA, HPLC/UHPLC, qPCR. Working experience in analytical/QC environment. Working experience in compliance with cGMP's, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities. Ability to work independently with skills for multi tests/projects. Ability to collaborate, communicate, and work effectively in a team-oriented. Good verbal and written communication skills. Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Traning systems. Education & Relevant Work Experience: Bachelor degree in biology, chemistry or other life science. At least 3-5 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus. Authorization to work in the United States indefinitely without restriction or sponsorship.
06/26/2022
Full time
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Editas is seeking a Quality Control Analyst II to join the Quality Control team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible for Method Transfer from Internal Analytic Development and/or External Testing Laboratories to Editas Quality Control at Editas Medicine. This position will be also responsible for performing a variety of QC testing including, but not limited to, using Flow Cytometry, FTIR, Osmometer, Cellometer, NanoDrop, ImageStream, UV-VIS, HPLC/UHPLC, PCR, Plate-reader, pH/Conductivity, Gel Electrophoresis and Compendial Methods. This position will work at both QC sites in Cambridge facility and Waltham facility, MA. Key Responsibilities & Accountabilities: Responsible for drafting, executing and reporting Method Transfer Protocols. Method tranfer is included, but not limited to, all release tests for Editas RNP and RNP buffer, and other drug substance and products. Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA, HPLC/UHPLC, qPCR, ImageStream Analysis, etc. Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required. Responsible for change controls, OOS and deviations, as required. Communicates with internal analysts in QC and different departments in Editas, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving. Perform other duties, as assigned. Requirements Knowledge, Experience, Skills & Capabilities: Working experience on method transfer. Hands-on experience minimally on following equipment/assays, but not limited to: Visual Appearance Inspection, pH, Osmolality, Subvisible Particle, K2 cellometer, NanoDrop, ELISA, HPLC/UHPLC, qPCR. Working experience in analytical/QC environment. Working experience in compliance with cGMP's, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities. Ability to work independently with skills for multi tests/projects. Ability to collaborate, communicate, and work effectively in a team-oriented. Good verbal and written communication skills. Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Traning systems. Education & Relevant Work Experience: Bachelor degree in biology, chemistry or other life science. At least 3-5 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus. Authorization to work in the United States indefinitely without restriction or sponsorship.
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Key Responsibilities & Accountabilities: Partner with External Manufacturing to develop and distribute timelines, agendas, meeting minutes, action items, dashboards, decision logs, etc. Create, socialize and manage project plans and timelines with clearly defined goals Run internal and externally facing meetings Identify and escalate timeline risks, mitigations and/or contingency plans Support management of strategic external relationships by aligning internal and external resources to achieve timelines and milestones Serve as externally-facing point of contact for select vendors and contract manufacturing organizations Review manufacturing documents and support tech transfer activities Coordinate material logistics and release with Supply Chain and QA Requirements Knowledge, Skills & Capabilities: Strong project management experience and proven track-record of managing external project to completion Exceptional organizational skills with the ability to multi-task and prioritize assignments, self-motivated with ability to work under pressure to meet deadlines Strong team player that has a customer service approach and is solution oriented Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors Education & Relevant Work Experience: B.S. in engineering, life sciences or related field with 5+ years of experience in biotech/pharmaceutical industry with experience working with external partners and vendors and at least 3 years of experience in a project management role Physical & Travel Requirements: Some travel required.
06/26/2022
Full time
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Key Responsibilities & Accountabilities: Partner with External Manufacturing to develop and distribute timelines, agendas, meeting minutes, action items, dashboards, decision logs, etc. Create, socialize and manage project plans and timelines with clearly defined goals Run internal and externally facing meetings Identify and escalate timeline risks, mitigations and/or contingency plans Support management of strategic external relationships by aligning internal and external resources to achieve timelines and milestones Serve as externally-facing point of contact for select vendors and contract manufacturing organizations Review manufacturing documents and support tech transfer activities Coordinate material logistics and release with Supply Chain and QA Requirements Knowledge, Skills & Capabilities: Strong project management experience and proven track-record of managing external project to completion Exceptional organizational skills with the ability to multi-task and prioritize assignments, self-motivated with ability to work under pressure to meet deadlines Strong team player that has a customer service approach and is solution oriented Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors Education & Relevant Work Experience: B.S. in engineering, life sciences or related field with 5+ years of experience in biotech/pharmaceutical industry with experience working with external partners and vendors and at least 3 years of experience in a project management role Physical & Travel Requirements: Some travel required.
Security Clearance: Applicants selected for this position will be required to obtain and maintain a U.S. Government Security Clearance. Responsibilities: Provides strategic leadership for a small, highly talented group of internal auditors. Responsible for coordinating the operations of the internal audit group to evaluate and monitor the overall risk management initiatives including the assessment and risk reduction actions of emerging and existing risks, internal controls, governance, and compliance with government accounting rules. Develops risk-based strategic audit plans for the next fiscal year and the following two years which will be adjusted as circumstances change. The objective of the audits is to deliver value-added recommendations that are in compliance with international standards for internal auditing. The Director must be able to effectively interact with all levels of management and be a trusted business advisor. The audit executive will report functionally to the board of directors through the audit committee and administratively (i.e., day-to-day operations) to the chief executive officer. strong coordination with The Director of Government Relations on internal audit staff activities. Organizational Duties: • Sets the tone for internal audit and internal control framework. • Prepares annual internal audit plan and obtain Audit Committee approval in the June meeting. Obtains buy-in on plan from constituents • Work with the Director of Compliance and Ethics and Director of Government Relations to determine if there are compliance areas that should be included as part of internal audit's annual plan • Prepares audit committee presentation and presents to the Audit Committee at regularly scheduled meetings. Works with the Chair of the Audit Committee between scheduled meetings as necessary to discuss and prepare for topics and risk areas meriting review • Establish effective working relationships with all key stakeholders, both inside and outside as well as being someone others will seek advice from prior to implementing new actions • Serves as an interface between company and the Defense Contract Management Agency (DCMA) and the Defense Contract Audit Agency (DCAA). Responsible to resolve any issues arising with DCAM and/or DCAA in conjunction with the company affected department • Amends Disclosure Statement as needed and resolves matters directly with DCMA. • Partners with various process owners to obtain agreement on internal control and process efficiency recommendations • Ensures all issued audit reports provide clarity and value-added recommendations. Departmental Management: • Recruit, motivate and train staff. This includes ensuring staff is adequately challenged, evaluated and provided professional development suitable to their needs. • Develop annual department goals/Key Performance Indicators and manage goals to achieve department objectives • Maintain knowledge of current trends and developments in the fields of internal auditing, financial reporting, government procurement and related areas • Develop annual department budget within establish guidelines Qualifications: • 10+ years of experience in auditing with at least 5 years in a management position that required establishing and managing internal audit plans and staff • Proven experience with building, leading and managing high performance teams. • Experience working with DCAA and DCMA management and government contracting environment • Strong executive presence and the ability to communicate to audiences with a broad range of experience • Ability to effectively deal with a fast paced and constantly changing environment Must be able to act decisively with limited facts available. • Knowledge and experience with the International standards for the practice of internal auditing. • Experience holding people and organizations accountable for due dates and attention to detail Education • Bachelor's degree in accounting or a related area is required. An MBA is also preferred. • Active relevant auditing credential required (CPA, CIA, etc.). • Knowledge of data analytics and information technology concepts is desirable.
06/26/2022
Full time
Security Clearance: Applicants selected for this position will be required to obtain and maintain a U.S. Government Security Clearance. Responsibilities: Provides strategic leadership for a small, highly talented group of internal auditors. Responsible for coordinating the operations of the internal audit group to evaluate and monitor the overall risk management initiatives including the assessment and risk reduction actions of emerging and existing risks, internal controls, governance, and compliance with government accounting rules. Develops risk-based strategic audit plans for the next fiscal year and the following two years which will be adjusted as circumstances change. The objective of the audits is to deliver value-added recommendations that are in compliance with international standards for internal auditing. The Director must be able to effectively interact with all levels of management and be a trusted business advisor. The audit executive will report functionally to the board of directors through the audit committee and administratively (i.e., day-to-day operations) to the chief executive officer. strong coordination with The Director of Government Relations on internal audit staff activities. Organizational Duties: • Sets the tone for internal audit and internal control framework. • Prepares annual internal audit plan and obtain Audit Committee approval in the June meeting. Obtains buy-in on plan from constituents • Work with the Director of Compliance and Ethics and Director of Government Relations to determine if there are compliance areas that should be included as part of internal audit's annual plan • Prepares audit committee presentation and presents to the Audit Committee at regularly scheduled meetings. Works with the Chair of the Audit Committee between scheduled meetings as necessary to discuss and prepare for topics and risk areas meriting review • Establish effective working relationships with all key stakeholders, both inside and outside as well as being someone others will seek advice from prior to implementing new actions • Serves as an interface between company and the Defense Contract Management Agency (DCMA) and the Defense Contract Audit Agency (DCAA). Responsible to resolve any issues arising with DCAM and/or DCAA in conjunction with the company affected department • Amends Disclosure Statement as needed and resolves matters directly with DCMA. • Partners with various process owners to obtain agreement on internal control and process efficiency recommendations • Ensures all issued audit reports provide clarity and value-added recommendations. Departmental Management: • Recruit, motivate and train staff. This includes ensuring staff is adequately challenged, evaluated and provided professional development suitable to their needs. • Develop annual department goals/Key Performance Indicators and manage goals to achieve department objectives • Maintain knowledge of current trends and developments in the fields of internal auditing, financial reporting, government procurement and related areas • Develop annual department budget within establish guidelines Qualifications: • 10+ years of experience in auditing with at least 5 years in a management position that required establishing and managing internal audit plans and staff • Proven experience with building, leading and managing high performance teams. • Experience working with DCAA and DCMA management and government contracting environment • Strong executive presence and the ability to communicate to audiences with a broad range of experience • Ability to effectively deal with a fast paced and constantly changing environment Must be able to act decisively with limited facts available. • Knowledge and experience with the International standards for the practice of internal auditing. • Experience holding people and organizations accountable for due dates and attention to detail Education • Bachelor's degree in accounting or a related area is required. An MBA is also preferred. • Active relevant auditing credential required (CPA, CIA, etc.). • Knowledge of data analytics and information technology concepts is desirable.
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Key Responsibilities & Accountabilities: The Senior Computer System Validation (CSV) Analyst will act as a thought-leader in the qualification and validation strategy around digital systems and new technologies deployed at Editas. Will be instrumental in developing and managing GxP lifecycle documentation using a risk-based approach. Documentation including, Validation Plans, Requirement Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports. Collaborate and partner with the key business stakeholders across IT and Operations Technology groups to include but not limited to: Analytical Development, Process Development, Quality Control, Data Science, Automation, Manufacturing Science & Technology and Quality Assurance. Collaborate with business to complete new and retrospective System Impact Assessments. Lead and proctor the User Acceptance Testing and PQ testing performed at Editas. Provide expertise for the investigation and compliant resolution of non-conformances encountered during validation activities. Drive results by owning and completing validation initiatives/projects against identified timelines. Own quality records such as Change Controls, Deviations, Corrective/Preventative Actions (CAPAs), and continuous improvement initiatives related to CSV activities. Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. Participate in the creation and/or review of Standard Operating Procedures (SOPs) for Validation department. Requirements Knowledge, Skills & Capabilities: Experience with industry-standard and best practices regarding validation and quality assurance principles and techniques (e.g., 21 CFR Part 11, GAMP 5). Knowledge of GxP best practices, international standards to quality management and methodology Diverse experience across a multitude of Digital GxP systems such as Enterprise Document Management System (EDMS), Electronic Quality Management System (eQMS), Supply Chain Management System (SCM), Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS) and Enterprise Resource Planning (ERP). Understanding of modern and risk based validation executions Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission/inspection. Able to work effectively as a part of a cross functional team and maintain good relationships with internal and external stakeholders. Strong interpersonal and communication skills. Education & Relevant Work Experience: Bachelor's Degree with 5 to 8 years of experience or Master's Degree with 2 to 5 years of experience in pharmaceutical/biotech industry with experience working in CSV or Quality role supporting computerized systems.
06/26/2022
Full time
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you. Key Responsibilities & Accountabilities: The Senior Computer System Validation (CSV) Analyst will act as a thought-leader in the qualification and validation strategy around digital systems and new technologies deployed at Editas. Will be instrumental in developing and managing GxP lifecycle documentation using a risk-based approach. Documentation including, Validation Plans, Requirement Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports. Collaborate and partner with the key business stakeholders across IT and Operations Technology groups to include but not limited to: Analytical Development, Process Development, Quality Control, Data Science, Automation, Manufacturing Science & Technology and Quality Assurance. Collaborate with business to complete new and retrospective System Impact Assessments. Lead and proctor the User Acceptance Testing and PQ testing performed at Editas. Provide expertise for the investigation and compliant resolution of non-conformances encountered during validation activities. Drive results by owning and completing validation initiatives/projects against identified timelines. Own quality records such as Change Controls, Deviations, Corrective/Preventative Actions (CAPAs), and continuous improvement initiatives related to CSV activities. Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. Participate in the creation and/or review of Standard Operating Procedures (SOPs) for Validation department. Requirements Knowledge, Skills & Capabilities: Experience with industry-standard and best practices regarding validation and quality assurance principles and techniques (e.g., 21 CFR Part 11, GAMP 5). Knowledge of GxP best practices, international standards to quality management and methodology Diverse experience across a multitude of Digital GxP systems such as Enterprise Document Management System (EDMS), Electronic Quality Management System (eQMS), Supply Chain Management System (SCM), Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS) and Enterprise Resource Planning (ERP). Understanding of modern and risk based validation executions Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission/inspection. Able to work effectively as a part of a cross functional team and maintain good relationships with internal and external stakeholders. Strong interpersonal and communication skills. Education & Relevant Work Experience: Bachelor's Degree with 5 to 8 years of experience or Master's Degree with 2 to 5 years of experience in pharmaceutical/biotech industry with experience working in CSV or Quality role supporting computerized systems.
We are a 140-year-old/9000-person Global Analytics Organization. Our mission: Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. BASIC FUNCTIONS: This intermediate position provides technical assistance to computer system users and answers questions or resolves computer problems for clients involving interaction in person, by telephone, by email, etc. This position is also responsible for diagnosing, troubleshooting, and resolving desktop, laptop, printer, computer hardware and software issues, operating system, electronic mail, and related issues. QUALIFICATIONS: • 1+ years of Service Desk experience • High school-level knowledge of computer hardware and software high school degree, technical certifications, or equivalent work experience required • A+ Certification or other technology certifications a plus TECHNICAL SKILLS: • Ability to configure workstations/laptops. • Good written/verbal communication skills. • Ability to troubleshoot operations issues. • Ability to complete basic hardware/software installations. • Good hardware/software troubleshooting skills. • Basic understanding of software monitoring tools. • Understanding of backup procedures. • Good problem-solving skills. • Good organizational skills. • Ability to travel less than 25%. ACCOUNTABILITIES: Under supervision, will monitor, support, troubleshoot, and resolve operating issues, including failures and service-level degradation. Initiate corrective actions to ensure connectivity and minimize downtime, with the overall goal of ensuring availability of the IT environment to employees and customers. Answer internal or external users' inquiries regarding computer hardware and software to resolve problems. Configure and set up workstations and laptops. Participate in troubleshooting and quickly arrive at workable solutions. Advise others on resolution and solutions in issues. Participate in the resolution of end user's desktop computer issues that may include but not limited to hardware, printer troubleshooting and configuration, installing software and/or hardware peripheral, perform daily backup procedures, liaise with third-party software/hardware vendors for problem resolution, and rollout of new software packages, upgrades, and new desktop hardware. Provide support and technical setup at some trade shows which includes periodic travel. Monitor, support, and troubleshoot the IT infrastructure for operating issues involving failures, degradation, and event correlation using various software and hardware monitoring tools. Perform troubleshooting and problem resolution for all types of the IT infrastructure as assigned - hardware, software, telecommunication, business application, customer connectivity, etc.
06/26/2022
Full time
We are a 140-year-old/9000-person Global Analytics Organization. Our mission: Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. BASIC FUNCTIONS: This intermediate position provides technical assistance to computer system users and answers questions or resolves computer problems for clients involving interaction in person, by telephone, by email, etc. This position is also responsible for diagnosing, troubleshooting, and resolving desktop, laptop, printer, computer hardware and software issues, operating system, electronic mail, and related issues. QUALIFICATIONS: • 1+ years of Service Desk experience • High school-level knowledge of computer hardware and software high school degree, technical certifications, or equivalent work experience required • A+ Certification or other technology certifications a plus TECHNICAL SKILLS: • Ability to configure workstations/laptops. • Good written/verbal communication skills. • Ability to troubleshoot operations issues. • Ability to complete basic hardware/software installations. • Good hardware/software troubleshooting skills. • Basic understanding of software monitoring tools. • Understanding of backup procedures. • Good problem-solving skills. • Good organizational skills. • Ability to travel less than 25%. ACCOUNTABILITIES: Under supervision, will monitor, support, troubleshoot, and resolve operating issues, including failures and service-level degradation. Initiate corrective actions to ensure connectivity and minimize downtime, with the overall goal of ensuring availability of the IT environment to employees and customers. Answer internal or external users' inquiries regarding computer hardware and software to resolve problems. Configure and set up workstations and laptops. Participate in troubleshooting and quickly arrive at workable solutions. Advise others on resolution and solutions in issues. Participate in the resolution of end user's desktop computer issues that may include but not limited to hardware, printer troubleshooting and configuration, installing software and/or hardware peripheral, perform daily backup procedures, liaise with third-party software/hardware vendors for problem resolution, and rollout of new software packages, upgrades, and new desktop hardware. Provide support and technical setup at some trade shows which includes periodic travel. Monitor, support, and troubleshoot the IT infrastructure for operating issues involving failures, degradation, and event correlation using various software and hardware monitoring tools. Perform troubleshooting and problem resolution for all types of the IT infrastructure as assigned - hardware, software, telecommunication, business application, customer connectivity, etc.
Archive Developer Chandra X-ray Telescope Data System This is an opportunity with the Data Systems division of the Chandra X-ray Center, which is part of the High Energy Astrophysics Division of the Smithsonian Astrophysical Observatory in Cambridge MA. One of NASA's Earth-orbiting Great Observatories, the Chandra X-ray telescope has been observing for over 20 years and continues to have a positive impact on the scientific understanding of the universe. We seek a Software Developer for the archive group to contribute to the continued success of the mission. Join the Chandra X-ray Center and become part of the team working to extend and maintain the Chandra Data archive functionality and to support its operations. The archive contains terabytes of data from the Chandra mission, ensures their integrity, security, and uninterrupted access, and provides interfaces for archiving and retrieval to Science Center Operations and Chandra Science users. Duties include: • Communicating with scientists and operations teams for software requirements • Developing and maintaining software through all phases of the software development lifecycle • Documenting software for CXC operations staff and scientific users worldwide • Release deployment, server and data migrations, and data archive monitoring • Problem analysis and evaluation in support of archive operations and scientific user input • Work as part of a team Knowledge required for the position may include: • Knowledge in C++ and Java • Exposure to SQL/rDBMS • Exposure to relational database servers, web, and JEE application servers in a Unix environment • Knowledge of and the ability to utilize scripting languages (e.g., Python, Perl) are beneficial since parts of the system include code written in these languages We offer a challenging and fulfilling working environment in partnership with scientists, operations staff, and an existing software development group, to bring Chandra data to the astronomical community at large. We accept only on-line applications for this position. For complete information and online application procedures, please visit We are an equal employment opportunity employer, committed to diversity in our workplace.
06/26/2022
Full time
Archive Developer Chandra X-ray Telescope Data System This is an opportunity with the Data Systems division of the Chandra X-ray Center, which is part of the High Energy Astrophysics Division of the Smithsonian Astrophysical Observatory in Cambridge MA. One of NASA's Earth-orbiting Great Observatories, the Chandra X-ray telescope has been observing for over 20 years and continues to have a positive impact on the scientific understanding of the universe. We seek a Software Developer for the archive group to contribute to the continued success of the mission. Join the Chandra X-ray Center and become part of the team working to extend and maintain the Chandra Data archive functionality and to support its operations. The archive contains terabytes of data from the Chandra mission, ensures their integrity, security, and uninterrupted access, and provides interfaces for archiving and retrieval to Science Center Operations and Chandra Science users. Duties include: • Communicating with scientists and operations teams for software requirements • Developing and maintaining software through all phases of the software development lifecycle • Documenting software for CXC operations staff and scientific users worldwide • Release deployment, server and data migrations, and data archive monitoring • Problem analysis and evaluation in support of archive operations and scientific user input • Work as part of a team Knowledge required for the position may include: • Knowledge in C++ and Java • Exposure to SQL/rDBMS • Exposure to relational database servers, web, and JEE application servers in a Unix environment • Knowledge of and the ability to utilize scripting languages (e.g., Python, Perl) are beneficial since parts of the system include code written in these languages We offer a challenging and fulfilling working environment in partnership with scientists, operations staff, and an existing software development group, to bring Chandra data to the astronomical community at large. We accept only on-line applications for this position. For complete information and online application procedures, please visit We are an equal employment opportunity employer, committed to diversity in our workplace.
Summary We are seeking an experienced intellectual property attorney to join our fast-growing team. You will be responsible for managing GentiBio's intellectual property portfolio and supporting intellectual property-related transactions. You will also work closely with our executive leadership, and the R&D and Corporate Development teams to develop and implement innovative patenting strategies that anticipate the business and competitive environment, including advising on in-licensing and out-licensing opportunities. This is an exciting opportunity to shape the IP strategy of a fast-growing cell therapy company in the emerging field of regulatory T-cell therapy. About us: GentiBio is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology from Seattle Children's Research Institute, Benaroya Research Institute, and MIGAL Galilee Research Institute. We are focused on the development of EngTregs programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio's proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T-cell therapeutics. Our corporate operations are in both Cambridge, MA and Seattle, WA. We are building an exceptional company culture focused on empowerment, care for one another, an appreciation for diversity and inclusion, and the development of our people. We are looking for people who are not only incredible experts in their field, but also individuals who are looking to contribute to building and modeling an outstanding company culture - and having fun while doing so. EEO Statement:GentiBio is proud to be an equal opportunity workplace and is an affirmative action employer. We are 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. If you have a disability or special need that requires accommodation, please let us know. Recruitment & staffing agencies:GentiBio does not accept agency resumes unless contacted directly by internal GentiBio Talent Acquisition. Please do not forward resumes to , GentiBio employees or any other company location; GentiBio is not responsible for any fees related to unsolicited resumes.
06/26/2022
Full time
Summary We are seeking an experienced intellectual property attorney to join our fast-growing team. You will be responsible for managing GentiBio's intellectual property portfolio and supporting intellectual property-related transactions. You will also work closely with our executive leadership, and the R&D and Corporate Development teams to develop and implement innovative patenting strategies that anticipate the business and competitive environment, including advising on in-licensing and out-licensing opportunities. This is an exciting opportunity to shape the IP strategy of a fast-growing cell therapy company in the emerging field of regulatory T-cell therapy. About us: GentiBio is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology from Seattle Children's Research Institute, Benaroya Research Institute, and MIGAL Galilee Research Institute. We are focused on the development of EngTregs programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio's proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T-cell therapeutics. Our corporate operations are in both Cambridge, MA and Seattle, WA. We are building an exceptional company culture focused on empowerment, care for one another, an appreciation for diversity and inclusion, and the development of our people. We are looking for people who are not only incredible experts in their field, but also individuals who are looking to contribute to building and modeling an outstanding company culture - and having fun while doing so. EEO Statement:GentiBio is proud to be an equal opportunity workplace and is an affirmative action employer. We are 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. If you have a disability or special need that requires accommodation, please let us know. Recruitment & staffing agencies:GentiBio does not accept agency resumes unless contacted directly by internal GentiBio Talent Acquisition. Please do not forward resumes to , GentiBio employees or any other company location; GentiBio is not responsible for any fees related to unsolicited resumes.
Crescent City Recruitment Group
Cambridge, Wisconsin
This full time, permanent first shift Manufacturing Cost Accountant is at a diverse construction, agriculture, and automotive component manufacturer. This employer cares about and values its employees. The company promotes professional growth through a variety of employer-sponsored training opportunities. This employer has even created part-time employment opportunities for employees near retirement that want or need to cut back on hours worked. The culture is about getting product out the door while still having an enjoyable workplace. The management team is very progressive in relationship to continuous improvement, operations improvement and building operations improvement with a goal of meeting the expectations of customers. The focus is on building strong teams and strong practices. Duties and responsibilities include the following: Confirming the accuracy of manufacturing accounting records Ensuring proper accounting related practices are being followed Ensuring accurate manufacturing accounting information is provided on time Overseeing budgeting Overseeing forecasting The background of the successful candidate must include the following: A four year accounting degree Six or more years of accounting experience Six or more years of Microsoft Excel and PowerPoint experience Three or more years of cost accounting experience Three or more years of Enterprise Resource Planning experience Two or more years of Materials Resource Planning experience Possess a solid work history Being a US citizen or green card holder Having a residence within a 45 minute drive
06/26/2022
Full time
This full time, permanent first shift Manufacturing Cost Accountant is at a diverse construction, agriculture, and automotive component manufacturer. This employer cares about and values its employees. The company promotes professional growth through a variety of employer-sponsored training opportunities. This employer has even created part-time employment opportunities for employees near retirement that want or need to cut back on hours worked. The culture is about getting product out the door while still having an enjoyable workplace. The management team is very progressive in relationship to continuous improvement, operations improvement and building operations improvement with a goal of meeting the expectations of customers. The focus is on building strong teams and strong practices. Duties and responsibilities include the following: Confirming the accuracy of manufacturing accounting records Ensuring proper accounting related practices are being followed Ensuring accurate manufacturing accounting information is provided on time Overseeing budgeting Overseeing forecasting The background of the successful candidate must include the following: A four year accounting degree Six or more years of accounting experience Six or more years of Microsoft Excel and PowerPoint experience Three or more years of cost accounting experience Three or more years of Enterprise Resource Planning experience Two or more years of Materials Resource Planning experience Possess a solid work history Being a US citizen or green card holder Having a residence within a 45 minute drive
ABOUT THE ORGANIZATION: Since 1991, Caterstaff has been the leader in providing professional service and culinary staff throughout New England. EOE STATEMENT: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. RATE OF PAY PER HOUR: $20/hr (no experience) up to $25 with related experience Description Starting pay $20/hr (no experience) and up to $25/hr with verified related experience. Established in 1991, Caterstaff is a New England based hospitality staffing company servicing caterers, institutions, clubs corporate and private clients. Event locations are located throughout the greater eastern Massachusetts area. (Boston, North Shore, South Shore, Worcester) We are NOT an app based, national job posting company and have strong, local relationships. Work at local high profile events, weddings, universities, private homes, corporate offices, and other locations. We offer: Flexible work schedule Quick pay option Referral bonus Carpooling provided to and from events if not T accessible Simplified, easy to use online scheduling. Working with Caterstaff: Meets with Catering Managers to discuss setup arrangements; handle last-minute changes and resolve problems, if needed. Interacts with customers in a service-oriented manner. Able to communicate menu items to guests. Set up/breakdown rooms according to Catering Manager specs Serves food and beverages to guests Maintains sanitation and orderliness of all equipment, supplies, and utensils. Work as a team with other catering wait staff members. WE'RE HIRING NOW! YOU WILL RECEIVE A RESPONSE WITHIN 48 HOURS! WE BOOK YOUR FREE TIME Starting pay $20/hr (no experience) and up to $25/hr with verified related experience. PM21 POSITION: Catering Wait Staff and bartenders - On Call PI
06/26/2022
Full time
ABOUT THE ORGANIZATION: Since 1991, Caterstaff has been the leader in providing professional service and culinary staff throughout New England. EOE STATEMENT: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. RATE OF PAY PER HOUR: $20/hr (no experience) up to $25 with related experience Description Starting pay $20/hr (no experience) and up to $25/hr with verified related experience. Established in 1991, Caterstaff is a New England based hospitality staffing company servicing caterers, institutions, clubs corporate and private clients. Event locations are located throughout the greater eastern Massachusetts area. (Boston, North Shore, South Shore, Worcester) We are NOT an app based, national job posting company and have strong, local relationships. Work at local high profile events, weddings, universities, private homes, corporate offices, and other locations. We offer: Flexible work schedule Quick pay option Referral bonus Carpooling provided to and from events if not T accessible Simplified, easy to use online scheduling. Working with Caterstaff: Meets with Catering Managers to discuss setup arrangements; handle last-minute changes and resolve problems, if needed. Interacts with customers in a service-oriented manner. Able to communicate menu items to guests. Set up/breakdown rooms according to Catering Manager specs Serves food and beverages to guests Maintains sanitation and orderliness of all equipment, supplies, and utensils. Work as a team with other catering wait staff members. WE'RE HIRING NOW! YOU WILL RECEIVE A RESPONSE WITHIN 48 HOURS! WE BOOK YOUR FREE TIME Starting pay $20/hr (no experience) and up to $25/hr with verified related experience. PM21 POSITION: Catering Wait Staff and bartenders - On Call PI
Job Req #: 661310 Job Description: IT Business Analyst, IDMP Location: Remote in the United States, working east coast hours Job Type: Six-month Contract that may extend Project Background Client in need of an IT Business Analyst, IDMP to help support functions. Key Responsibilities: Lead business requirements documentation and business process mapping Solve problems, advise about operational needs, and give expertise on business processes opportunities Advise stakeholders to prioritize requirements and to ensure the total solution delivered to the customer meets/exceeds expectations Execute and integrate small to large-scale changes and requirements in the delivery of the project Analyze and communicate business requirements and provide business IT consulting support Follow company and departmental policies, procedures and ensure documentation according to the Client's Quality Management Systems (QMS), Software Development Life Cycle and Project Life Cycle standards Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability Build and maintain relationships with key business stakeholders Demonstrate strong Agile Methodology and Scrum Framework knowledge Participate in Scrum ceremonies including daily standups, sprint reviews, backlog refinement, etc Support Product Manager with sprint planning Manage and orchestrate team participation and drive Backlog Refinement Qualifications: Requirements Gathering 4 - Strong Life Sciences -> Pharmaceuticals 3 - Comfortable Compliance -> Compliance - Life Sciences - Systems Validation 3 - Comfortable Required: Previous pharma experience Understanding of 21 CFR Part 11 and computer system validation Minimum 5 years' experience analyzing and documenting complex technical requirements Desired: Regulatory Affairs support Previous experience with Product Labeling Previous experience managing migration projects Working knowledge of Veeva Previous experience supporting the implementation of data lakes / digital backbones Working knowledge of IDMP Diane Douglas Senior Technical Recruiter About Ascent: The Ascent Services Group (ASG) is a nationally recognized technology staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences. As consultants for ASG, you will have access to many of the top clients within the industries we serve. Our goal is to deliver innovative talent through proven best practices and effective resource optimization. Become one of ASG's candidates and experience the difference!
06/26/2022
Full time
Job Req #: 661310 Job Description: IT Business Analyst, IDMP Location: Remote in the United States, working east coast hours Job Type: Six-month Contract that may extend Project Background Client in need of an IT Business Analyst, IDMP to help support functions. Key Responsibilities: Lead business requirements documentation and business process mapping Solve problems, advise about operational needs, and give expertise on business processes opportunities Advise stakeholders to prioritize requirements and to ensure the total solution delivered to the customer meets/exceeds expectations Execute and integrate small to large-scale changes and requirements in the delivery of the project Analyze and communicate business requirements and provide business IT consulting support Follow company and departmental policies, procedures and ensure documentation according to the Client's Quality Management Systems (QMS), Software Development Life Cycle and Project Life Cycle standards Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability Build and maintain relationships with key business stakeholders Demonstrate strong Agile Methodology and Scrum Framework knowledge Participate in Scrum ceremonies including daily standups, sprint reviews, backlog refinement, etc Support Product Manager with sprint planning Manage and orchestrate team participation and drive Backlog Refinement Qualifications: Requirements Gathering 4 - Strong Life Sciences -> Pharmaceuticals 3 - Comfortable Compliance -> Compliance - Life Sciences - Systems Validation 3 - Comfortable Required: Previous pharma experience Understanding of 21 CFR Part 11 and computer system validation Minimum 5 years' experience analyzing and documenting complex technical requirements Desired: Regulatory Affairs support Previous experience with Product Labeling Previous experience managing migration projects Working knowledge of Veeva Previous experience supporting the implementation of data lakes / digital backbones Working knowledge of IDMP Diane Douglas Senior Technical Recruiter About Ascent: The Ascent Services Group (ASG) is a nationally recognized technology staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences. As consultants for ASG, you will have access to many of the top clients within the industries we serve. Our goal is to deliver innovative talent through proven best practices and effective resource optimization. Become one of ASG's candidates and experience the difference!
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Sr. Medical Development Director, Oncology Company: Ipsen Bioscience, Inc. Job Description: Summary / purpose of the position The Senior Medical Development Director (Sr MDD) is responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsen's individual drugs (oncology) in partnership with Global Project Teams and in accordance with Target Product Profiles (TPP) as jointly developed with the Franchise. This position may also have a particular focus on leading the Global Project Team with overall accountability for a specific Drug Development program, designated as Global Development Lead (GDL). The Sr. MDD has oversight in managing a team of Medical Development Directors (MDDs) and Clinical Scientists. This position: Recognized as an influential leader, develops, proposes, and influences project and R&D teams on new uses for compounds currently in proof of concept and/or life cycle management. Provides solutions to senior managers in various areas, groups, and/or operations based on medical subject matter experience. Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration Ensures from a medical perspective compliance with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities Works closely in partnership with Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing medical support for drug development programs Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results. Manages effectively relationships in a cross functional and matrix environment with internal and external stakeholders Advises Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions. May provide pivotal medical input to Ipsen's individual drugs, including but not limited to recently acquired assets, and to support regional and/or global drug development Main responsibilities / job expectations Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%) Lead and manage the team, including recruitment, people development, talent management and performance management. Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch Participate with Asset Lead, TA Head and other senior managers in establishing strategic plans and objectives Provide medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP Assume ownership of CDP and medical aspects of IDP, and supervises CDP and IDP contributions of MDDs; ensure execution of CDP and establish where necessary cross-functional alignment to support execution of CDP Share with Clinical Operations responsibility of clinical trials oversight and ensure the efficient, safe, ethical and high-quality conduct of clinical trials Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with CRO representatives Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conference or alike Core Remit of Activities External to Therapeutic Area Development (approx. 35%) Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen GDDev at investigator meetings, expert panels, advisory boards or alike Provide upon request tactical support to Joint Development Committees, Joint Steering Committees and Due Diligence Teams Proactively liaise with Global Drug Discovery to ensure scientific and medical integrity of IDP, TPP etc. Liaise with key internal experts as required to support pre-clinical programs and Project Teams for most efficient development of new chemical entities Liaise with Early Clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies) Liaise with Late Drug Development platform and Franchises to both integrate business needs into IDP and to report progress of development programs with focus on patient safety and potential business risks and opportunities General duties and responsibilities Oversight, management, development and mentorship of team. Comply with Ipsen's SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research Develop and maintain state of the art scientific, medical and managerial knowledge by : Establishing and maintaining an external professional network Reading pertinent scientific and medical publications Attending pertinent training courses, workshops, conferences etc. Proactively and reactively inform, as appropriate and legally required, Global Drug Safety, Project Team, Clinical Study Team and functional leads of : Any safety signals emerging from clinical trials Any emerging medical risks and opportunities with an impact on timely and successful completion of development programs Commit to support transformation and change management of R&D division with a focus on high performance culture, data quality, timeliness and budget control accounts Assume tasks within the context of team performance and project progress in an objective-driven, solution and results oriented manner with an overall can-do attitude Be a proactive member and contributor to Ipsen's medical community Knowledge, abilities & experience Education / Certifications: Medical doctor, board certified in oncology or proven expertise in oncology drug development is preferred Knowledge & Experience: Minimum 5 years' proven experience in oncology development area (from pre-clinical to registration). Industry experience an asset. Strong leadership skills in global matrix environment Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management Previous experience directly and independently leading projects and/or a team of professionals Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others (above and beyond ones' own function) Ability and willingness to assume domestic and international travel Ability and willingness to work in a global matrix organisation and in cross-functional teams Key Technical Competencies Required Strategic and creative thinking. Find and develop unique opportunities to create value by enabling a provocative and creative dialogue among people who can affect Ipsen's direction. Have a good knowledge of the fundamental drivers of a business and rigorously challenging conventional thinking about them (capacity to think out of the box), in conversation with others. Broad an individual's perspective to achieve innovation, competitive edge or more successful outcomes. Influencing and leadership. Enable, motivate, coach, and inspire the team and the stakeholders to meet deliverables within project constraints by demonstrating commitment, expertise, confidence, genuine concern, and ability to help everyone solve challenges and achieve goals. Collaboration / Teambuilding. Establish a collaborative culture where people with unique personalities and skills happily work together towards a unified goal. Build relation with a wide spectrum of internal and external academicians, in the scientific/medical arena. Drug Development Value Chain expertise. Have a strong knowledge of the value chain from gene sequencing to distribution and specially of the Clinical Trials (Phases I, II, and III). Learning Skills. Find ways to stay current. Become actively involved in medical societies within the community you serve. Maintain high level of knowledge about ethic and compliance referential. Planning. Organize tasks in the right order, to hit the right outcome at the right time to maintaining a high level of professionalism regardless of tight deadlines and pressure. Decision-Making. Make prompt, informed, and fact-based decisions for the good of the project. Results-orientation..... click apply for full job details
06/26/2022
Full time
Title: Sr. Medical Development Director, Oncology Company: Ipsen Bioscience, Inc. Job Description: Summary / purpose of the position The Senior Medical Development Director (Sr MDD) is responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsen's individual drugs (oncology) in partnership with Global Project Teams and in accordance with Target Product Profiles (TPP) as jointly developed with the Franchise. This position may also have a particular focus on leading the Global Project Team with overall accountability for a specific Drug Development program, designated as Global Development Lead (GDL). The Sr. MDD has oversight in managing a team of Medical Development Directors (MDDs) and Clinical Scientists. This position: Recognized as an influential leader, develops, proposes, and influences project and R&D teams on new uses for compounds currently in proof of concept and/or life cycle management. Provides solutions to senior managers in various areas, groups, and/or operations based on medical subject matter experience. Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration Ensures from a medical perspective compliance with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities Works closely in partnership with Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing medical support for drug development programs Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results. Manages effectively relationships in a cross functional and matrix environment with internal and external stakeholders Advises Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions. May provide pivotal medical input to Ipsen's individual drugs, including but not limited to recently acquired assets, and to support regional and/or global drug development Main responsibilities / job expectations Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%) Lead and manage the team, including recruitment, people development, talent management and performance management. Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch Participate with Asset Lead, TA Head and other senior managers in establishing strategic plans and objectives Provide medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP Assume ownership of CDP and medical aspects of IDP, and supervises CDP and IDP contributions of MDDs; ensure execution of CDP and establish where necessary cross-functional alignment to support execution of CDP Share with Clinical Operations responsibility of clinical trials oversight and ensure the efficient, safe, ethical and high-quality conduct of clinical trials Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with CRO representatives Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conference or alike Core Remit of Activities External to Therapeutic Area Development (approx. 35%) Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen GDDev at investigator meetings, expert panels, advisory boards or alike Provide upon request tactical support to Joint Development Committees, Joint Steering Committees and Due Diligence Teams Proactively liaise with Global Drug Discovery to ensure scientific and medical integrity of IDP, TPP etc. Liaise with key internal experts as required to support pre-clinical programs and Project Teams for most efficient development of new chemical entities Liaise with Early Clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies) Liaise with Late Drug Development platform and Franchises to both integrate business needs into IDP and to report progress of development programs with focus on patient safety and potential business risks and opportunities General duties and responsibilities Oversight, management, development and mentorship of team. Comply with Ipsen's SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research Develop and maintain state of the art scientific, medical and managerial knowledge by : Establishing and maintaining an external professional network Reading pertinent scientific and medical publications Attending pertinent training courses, workshops, conferences etc. Proactively and reactively inform, as appropriate and legally required, Global Drug Safety, Project Team, Clinical Study Team and functional leads of : Any safety signals emerging from clinical trials Any emerging medical risks and opportunities with an impact on timely and successful completion of development programs Commit to support transformation and change management of R&D division with a focus on high performance culture, data quality, timeliness and budget control accounts Assume tasks within the context of team performance and project progress in an objective-driven, solution and results oriented manner with an overall can-do attitude Be a proactive member and contributor to Ipsen's medical community Knowledge, abilities & experience Education / Certifications: Medical doctor, board certified in oncology or proven expertise in oncology drug development is preferred Knowledge & Experience: Minimum 5 years' proven experience in oncology development area (from pre-clinical to registration). Industry experience an asset. Strong leadership skills in global matrix environment Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management Previous experience directly and independently leading projects and/or a team of professionals Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others (above and beyond ones' own function) Ability and willingness to assume domestic and international travel Ability and willingness to work in a global matrix organisation and in cross-functional teams Key Technical Competencies Required Strategic and creative thinking. Find and develop unique opportunities to create value by enabling a provocative and creative dialogue among people who can affect Ipsen's direction. Have a good knowledge of the fundamental drivers of a business and rigorously challenging conventional thinking about them (capacity to think out of the box), in conversation with others. Broad an individual's perspective to achieve innovation, competitive edge or more successful outcomes. Influencing and leadership. Enable, motivate, coach, and inspire the team and the stakeholders to meet deliverables within project constraints by demonstrating commitment, expertise, confidence, genuine concern, and ability to help everyone solve challenges and achieve goals. Collaboration / Teambuilding. Establish a collaborative culture where people with unique personalities and skills happily work together towards a unified goal. Build relation with a wide spectrum of internal and external academicians, in the scientific/medical arena. Drug Development Value Chain expertise. Have a strong knowledge of the value chain from gene sequencing to distribution and specially of the Clinical Trials (Phases I, II, and III). Learning Skills. Find ways to stay current. Become actively involved in medical societies within the community you serve. Maintain high level of knowledge about ethic and compliance referential. Planning. Organize tasks in the right order, to hit the right outcome at the right time to maintaining a high level of professionalism regardless of tight deadlines and pressure. Decision-Making. Make prompt, informed, and fact-based decisions for the good of the project. Results-orientation..... click apply for full job details
Cellmig Biolabs Research Scientist - Cancer Antibody Medicine Cellmig Biolabs Inc., a global leading group in precise and effective cancer diagnosis and therapy area, is translating pioneering discoveries into cancer medicines for the diagnosis and pharmacotherapy of all kinds of solid and liquid cancers. Cellmig has successfully identified a novel organelle termed cytocapsular tube, which significantly expands our understanding of the mechanisms of cancer evolution and metastasis and promote precise and effective cancer drug development. Our goal is to translate these findings into creating breakthrough biomolecules and diagnostic devices for the precise and effective cancer diagnosis and therapy. The Core Research Center at Cellmig Biolabs Inc. is searching for 4 Research Scientists to join our Antibody Development team. We are seeking a highly motivated and independent individual with a background in immunohistochemistry staining and/or antibody development work. A strong candidate will play a critical role in the validation of our first antibody product for FDA approval, performing cutting edge cancer biology research. Cellmig offers growth potential and a stimulating environment with a culture of excellence in science and product development. The candidate will be part of an integrated, interdisciplinary team developing powerful new diagnostic products for cancer metastasis. Duties and Responsibilities The core responsibility of this position is to build and maintain Cellmig's validation needs for the company's a series of In Vivo, non-invasive and 3D MRI and CT-scan products, and In Vitro Diagnostic (IVD) immunohistochemistry (IHC) devices for precise and efficient cancer screening and diagnosis.This role will work directly with the Validation team and Quality Assurance to establish and drive the validation and verification needs for FDA approval, as per the Quality Systems Management requirements and regulations found in ISO 13485: 2016, FDA QSRs, and other applicable standards for IHC Assays. These individuals will work with the antibody development team to assist and guide on all in vivo and in vitro assay validation needs. Such activities include, but not limited to: Design, develop, validate, and maintain Cellmig's IHC assay methods and procedures for Cellmig IVD product(s). Perform, troubleshoot and/or optimize established procedures and protocols, including immunohistochemistry staining, SDS-Page, Western blot, mammalian cell culture, fluorescent microscopy and other related cell and molecular biology assays. Play a crucial role during the Design and Development phases of the first antibody product and future diagnostic products. Contribute to tasks for product Verification and Validation activities of new product developments and next generation devices. Analyze and interpret data collected in experiments and studies. Develop antibodies and nanobodies for in vivo (MRI, CT-scan, and PET-CT) and in vitro (IHC, and photocleave IHC) precise and efficient cancer diagnosis. Take initiative to drive projects forward by suggesting experiments to test, researching new methods/cutting edge technology, and always learning new skills. Recommend and implement new tools to optimize processes, procedures, and test methods. Follow proper documentation control procedures. Maintain accurate laboratory records. Assist other team members and support expansion of the Antibody Development team. Present data and project status as weekly and/or bi-weekly team meetings. Proactively solve problems to drive project advancement. Qualifications and Eligibility Industry experience in IVD assay development, specifically Immunohistochemistry (IHC) IVD assays, is preferable. USA citizen is required. Training, Skills, Experience, and Other Competencies Demonstrates strong knowledge in antibody development and immunohistochemistry techniques. Experience with a variety of cell and molecular biology skills, such as mammalian cell culture, Western Blot, qPCR, protein purification, and/or transfection, etc. is favorable. Ability to develop, optimize, and write SOPs, work instructions, reports, and project plans. Previous work with fluorescent, phase-contrast, and/or bright field microscopy, with a strong understanding of image analysis is essential. Ability to independently design experiments, analyze complex data, and interpret/present data results is necessary. Display analytical, problem-solving, and decision-making skills. Ability to work in a team environment and work across multiple departments. Adept in developing a strong understanding of regulatory agency requirements applicable to validation of Immunohistochemistry (IHC) Vitro Diagnostic medical devices and compliance. Minimum Required Level of Education Master's degree in biology or science related field with a minimum of 4 years of industry experience; or PhD in biology or science related field with a minimum of 2 year of industry experience. Address: 245 First Street, Cambridge, MA 02142
06/26/2022
Full time
Cellmig Biolabs Research Scientist - Cancer Antibody Medicine Cellmig Biolabs Inc., a global leading group in precise and effective cancer diagnosis and therapy area, is translating pioneering discoveries into cancer medicines for the diagnosis and pharmacotherapy of all kinds of solid and liquid cancers. Cellmig has successfully identified a novel organelle termed cytocapsular tube, which significantly expands our understanding of the mechanisms of cancer evolution and metastasis and promote precise and effective cancer drug development. Our goal is to translate these findings into creating breakthrough biomolecules and diagnostic devices for the precise and effective cancer diagnosis and therapy. The Core Research Center at Cellmig Biolabs Inc. is searching for 4 Research Scientists to join our Antibody Development team. We are seeking a highly motivated and independent individual with a background in immunohistochemistry staining and/or antibody development work. A strong candidate will play a critical role in the validation of our first antibody product for FDA approval, performing cutting edge cancer biology research. Cellmig offers growth potential and a stimulating environment with a culture of excellence in science and product development. The candidate will be part of an integrated, interdisciplinary team developing powerful new diagnostic products for cancer metastasis. Duties and Responsibilities The core responsibility of this position is to build and maintain Cellmig's validation needs for the company's a series of In Vivo, non-invasive and 3D MRI and CT-scan products, and In Vitro Diagnostic (IVD) immunohistochemistry (IHC) devices for precise and efficient cancer screening and diagnosis.This role will work directly with the Validation team and Quality Assurance to establish and drive the validation and verification needs for FDA approval, as per the Quality Systems Management requirements and regulations found in ISO 13485: 2016, FDA QSRs, and other applicable standards for IHC Assays. These individuals will work with the antibody development team to assist and guide on all in vivo and in vitro assay validation needs. Such activities include, but not limited to: Design, develop, validate, and maintain Cellmig's IHC assay methods and procedures for Cellmig IVD product(s). Perform, troubleshoot and/or optimize established procedures and protocols, including immunohistochemistry staining, SDS-Page, Western blot, mammalian cell culture, fluorescent microscopy and other related cell and molecular biology assays. Play a crucial role during the Design and Development phases of the first antibody product and future diagnostic products. Contribute to tasks for product Verification and Validation activities of new product developments and next generation devices. Analyze and interpret data collected in experiments and studies. Develop antibodies and nanobodies for in vivo (MRI, CT-scan, and PET-CT) and in vitro (IHC, and photocleave IHC) precise and efficient cancer diagnosis. Take initiative to drive projects forward by suggesting experiments to test, researching new methods/cutting edge technology, and always learning new skills. Recommend and implement new tools to optimize processes, procedures, and test methods. Follow proper documentation control procedures. Maintain accurate laboratory records. Assist other team members and support expansion of the Antibody Development team. Present data and project status as weekly and/or bi-weekly team meetings. Proactively solve problems to drive project advancement. Qualifications and Eligibility Industry experience in IVD assay development, specifically Immunohistochemistry (IHC) IVD assays, is preferable. USA citizen is required. Training, Skills, Experience, and Other Competencies Demonstrates strong knowledge in antibody development and immunohistochemistry techniques. Experience with a variety of cell and molecular biology skills, such as mammalian cell culture, Western Blot, qPCR, protein purification, and/or transfection, etc. is favorable. Ability to develop, optimize, and write SOPs, work instructions, reports, and project plans. Previous work with fluorescent, phase-contrast, and/or bright field microscopy, with a strong understanding of image analysis is essential. Ability to independently design experiments, analyze complex data, and interpret/present data results is necessary. Display analytical, problem-solving, and decision-making skills. Ability to work in a team environment and work across multiple departments. Adept in developing a strong understanding of regulatory agency requirements applicable to validation of Immunohistochemistry (IHC) Vitro Diagnostic medical devices and compliance. Minimum Required Level of Education Master's degree in biology or science related field with a minimum of 4 years of industry experience; or PhD in biology or science related field with a minimum of 2 year of industry experience. Address: 245 First Street, Cambridge, MA 02142
ABOUT THE ORGANIZATION: Since 1991, Caterstaff has been the leader in providing professional service and culinary staff throughout New England. EOE STATEMENT: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. RATE OF PAY PER HOUR: Starting pay $20/hr (no experience) and up to $25/hr with verified related experience. Description Caterstaff is an established event staffing company in the Boston area servicing large and small catering companies. We've been providing expert catering wait staffi and culinary staff services for clients throughout Eastern MA since 1991. Work at local high profile events, weddings, universities, private homes, corporate offices, clubs and other locations. WE OFFER: flexible work schedule quick pay option yearly bonus referral bonus carpooling provided to and from events if not T accessible *Must be eligible. Terms and Conditions apply Simplified app based scheduling Job Overview Meets with Catering Managers to discuss setup arrangements; handle last-minute changes and resolve problems, if needed. Interacts with customers in a service-oriented manner. Able to communicate menu items to guests. Set up/breakdown rooms according to Catering Manager specs Serves food and beverages to guests Maintains sanitation and orderliness of all equipment, supplies, and utensils. Work as a team with other catering wait staff members. WE'RE HIRING NOW! YOU WILL RECEIVE A RESPONSE WITHIN 24 HOURS! PM21 POSITION: Catering Wait Staff - Eastern Massachusetts - On Call PI
06/26/2022
Full time
ABOUT THE ORGANIZATION: Since 1991, Caterstaff has been the leader in providing professional service and culinary staff throughout New England. EOE STATEMENT: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. RATE OF PAY PER HOUR: Starting pay $20/hr (no experience) and up to $25/hr with verified related experience. Description Caterstaff is an established event staffing company in the Boston area servicing large and small catering companies. We've been providing expert catering wait staffi and culinary staff services for clients throughout Eastern MA since 1991. Work at local high profile events, weddings, universities, private homes, corporate offices, clubs and other locations. WE OFFER: flexible work schedule quick pay option yearly bonus referral bonus carpooling provided to and from events if not T accessible *Must be eligible. Terms and Conditions apply Simplified app based scheduling Job Overview Meets with Catering Managers to discuss setup arrangements; handle last-minute changes and resolve problems, if needed. Interacts with customers in a service-oriented manner. Able to communicate menu items to guests. Set up/breakdown rooms according to Catering Manager specs Serves food and beverages to guests Maintains sanitation and orderliness of all equipment, supplies, and utensils. Work as a team with other catering wait staff members. WE'RE HIRING NOW! YOU WILL RECEIVE A RESPONSE WITHIN 24 HOURS! PM21 POSITION: Catering Wait Staff - Eastern Massachusetts - On Call PI
Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Business Solutions Expert in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Leads the analysis of complex business problems and manages business requirements within area of responsibilities. Leads development of scope definition and business priority-setting. Proactively identifies technology solutions to meet business objectives, taking into account the implications of change on the organization and all stakeholders. Partners with IT business partner leads serving scientific business functions to drive lab operating model efficiencies, standards, and innovative methods. Works with other Capability and Products teams to ensure collaboration on application changes and new systems deployment happening outside the lab. Partners with infrastructure services to ensure holistic support of the lab computing environment. POSITION ACCOUNTABILITIES: Manages implementation of major upgrades across the R&D and SBU lab enterprise; ensures backup/recovery, security, configuration management, and apt "help desk" support. Works closely with business and IT Quality functions to maintain GxP compliance and perform validations. Identifies avenues for continuous improvement for lab computing services within scope of responsibility, including new approaches and processes that would contribute both to improvements within department and to business growth/efficiency in the wider organization. Manages the technology requirements of new lab builds, lab moves and site consolidations. Manages strategic communications around lab computing services, processes, technology and performance. Manages requirements gathering, prioritization and negotiation with business stakeholders in order to ensure the total solution delivered meets or exceeds expectations. Maintains and influences business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases. Solves unique and complex problems with a broad impact on the business and interprets ways of prioritizing opportunities to streamline business and/or system processes. Uses knowledge of business operations, investigates and identifies operational needs, problems and opportunities and uses Business Process Mapping to phrase and manage requirements or organizational improvements. Provides leadership to project team to deliver mid-size and moderate complex system implementations, within cross functional projects that allow the business to reach its strategic objectives in a cost effective way. Makes decisions that impact, the work of employing organizations, achievement of organizational objectives or/and financial performance. Has authority and responsibility for a significant area of work, including technical, financial and quality aspects and may represent the organization. Ensures documentation according to Takeda Quality Management System (QMS), Software Development Life Cycle and Project Life Cycle standards. Ensures delivered solutions are compliant with associated federal regulations (SOX, OFCCP, labour laws, GMP, GxP, GCP, etc.). Is a subject matter expert in the business area of expertise and actively shares emerging industry standards/trends with customers and peers. Issues POs for lab computing goods/services and reconcile invoices. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Required: Bachelor Degree or equivalent 5 years or more of relevant experience. Ability to write, speak and lead in the English language. Excellent oral and written communications skills, business acumen with problem solving and analytical skills. Professional in depth knowledge of business processes in pharmaceutical industry within functional area. Knowledge of business and system solutions and experience with implementing applications. Experience in Business Analysis and Project Management. Experience in Stakeholder relationship management. Experience in communicating complex information in a clear and engaging manner, adjust form and meetings to this and builds collaborative network of relationships in the business area and outside. Experience in presenting on conferences and business meetings. Preferred: Master Degree. Experience in managing people. Experience with regulated systems - good level of understanding of system validation. LICENSES/CERTIFICATIONS: Project Management Professional (PMP) or equivalent Business Process Management. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
06/26/2022
Full time
Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Business Solutions Expert in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Leads the analysis of complex business problems and manages business requirements within area of responsibilities. Leads development of scope definition and business priority-setting. Proactively identifies technology solutions to meet business objectives, taking into account the implications of change on the organization and all stakeholders. Partners with IT business partner leads serving scientific business functions to drive lab operating model efficiencies, standards, and innovative methods. Works with other Capability and Products teams to ensure collaboration on application changes and new systems deployment happening outside the lab. Partners with infrastructure services to ensure holistic support of the lab computing environment. POSITION ACCOUNTABILITIES: Manages implementation of major upgrades across the R&D and SBU lab enterprise; ensures backup/recovery, security, configuration management, and apt "help desk" support. Works closely with business and IT Quality functions to maintain GxP compliance and perform validations. Identifies avenues for continuous improvement for lab computing services within scope of responsibility, including new approaches and processes that would contribute both to improvements within department and to business growth/efficiency in the wider organization. Manages the technology requirements of new lab builds, lab moves and site consolidations. Manages strategic communications around lab computing services, processes, technology and performance. Manages requirements gathering, prioritization and negotiation with business stakeholders in order to ensure the total solution delivered meets or exceeds expectations. Maintains and influences business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases. Solves unique and complex problems with a broad impact on the business and interprets ways of prioritizing opportunities to streamline business and/or system processes. Uses knowledge of business operations, investigates and identifies operational needs, problems and opportunities and uses Business Process Mapping to phrase and manage requirements or organizational improvements. Provides leadership to project team to deliver mid-size and moderate complex system implementations, within cross functional projects that allow the business to reach its strategic objectives in a cost effective way. Makes decisions that impact, the work of employing organizations, achievement of organizational objectives or/and financial performance. Has authority and responsibility for a significant area of work, including technical, financial and quality aspects and may represent the organization. Ensures documentation according to Takeda Quality Management System (QMS), Software Development Life Cycle and Project Life Cycle standards. Ensures delivered solutions are compliant with associated federal regulations (SOX, OFCCP, labour laws, GMP, GxP, GCP, etc.). Is a subject matter expert in the business area of expertise and actively shares emerging industry standards/trends with customers and peers. Issues POs for lab computing goods/services and reconcile invoices. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Required: Bachelor Degree or equivalent 5 years or more of relevant experience. Ability to write, speak and lead in the English language. Excellent oral and written communications skills, business acumen with problem solving and analytical skills. Professional in depth knowledge of business processes in pharmaceutical industry within functional area. Knowledge of business and system solutions and experience with implementing applications. Experience in Business Analysis and Project Management. Experience in Stakeholder relationship management. Experience in communicating complex information in a clear and engaging manner, adjust form and meetings to this and builds collaborative network of relationships in the business area and outside. Experience in presenting on conferences and business meetings. Preferred: Master Degree. Experience in managing people. Experience with regulated systems - good level of understanding of system validation. LICENSES/CERTIFICATIONS: Project Management Professional (PMP) or equivalent Business Process Management. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
EXOS is a leader in the field of human performance, a category it created more than 20 years ago. For two decades we've stood side by side with the very best, coaching individuals, teams, and communities to higher levels of performance. And we've done it all by pioneering and leveraging sports science and proprietary tools across mindset, nutrition, movement, and recovery. Today, EXOS employs more than 4,000 people in over 400 locations worldwide. With award-winning facilities, sports medicine clinics, technology, and services, EXOS connects people to the solutions they need. We provide comprehensive game plans, regardless of skill and sport, based on time-tested fundamentals and research in order to help people take control of their health and performance. EXOS is trusted by hundreds of clients including leaders in business, technology, health, community organizations, and world champions in sports. Now we're leaning into our rich heritage to move the brand forward. In 2020, EXOS founder and president Mark Verstegen brought on industry vet Sarah Robb O'Hagan as CEO to lead the company into its next chapter. Culturally, we promote and reward humility, one team and tenacity as some of our core values and we are committed to cultivating an inclusive work environment where all of our team members feel empowered to grow and bring their whole selves every day. We celebrate the diverse voices and perspectives of our team members, knowing that diversity of age, race, ethnicity, gender identity, sexual orientation, veteran status and national origin, among other social identities, drive innovation, belonging and fuel our work. Job Summary: Job Description: Responsibilities We're seeking a Group Exercise instructor to lead our fitness classes. As our new Group Exercise instructor you must be: * Enthusiastic about group exercise classes and enjoy creating and delivering new, fresh and innovative routines * Confident in your professionalism by reporting on-time with a positive attitude and a passion to motivate others * A professional who is collaborative and a flexible leader in and out of the studio The Ideal Candidate will have: * Minimum of one year of experience actively leading successful group exercise classes * Current nationally accredited group exercise certification (e.g. AFAA, ACE, ACSM, NETA) if necessary * Instructors teaching licensed/branded formats (e.g. Zumba, Yoga) must also be trained and licensed to teach those specific formats * Current CPR/AED certification (First Aid certification is strongly desired) To prevent the infection and spread of COVID-19, and as an integral part of its public health and safety measures, EXOS requires that all successful applicants shall be required to show proof of full vaccination by an FDA-approved COVID-19 vaccine before beginning employment, unless an exemption from this policy has been granted as an accommodation or otherwise. Applicants believing they need an accommodation of this policy because of a disability, sincerely-held religious belief, or otherwise should inform People Operations after an offer of employment is extended; please do not include any medical, genetic, or religious information on your application materials. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! We are an equal opportunity employer EXOS is proud to be an affirmative action / equal opportunity employer. All qualified applicants will receive consideration without regard to race, creed, gender, marital status, sexual orientation, citizenship status, color, religion, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws. EXOS provides reasonable accommodation to employees and applicants for employment who have disabilities. You may request reasonable accommodation, in writing, by reaching out to our People Operations department at: Attention: People Operations, Accommodations 2629 E. Rose Garden Ln. Phoenix, AZ 85050 Learn more here: * EEO is the Law * EEO is the Law Supplement
06/26/2022
Full time
EXOS is a leader in the field of human performance, a category it created more than 20 years ago. For two decades we've stood side by side with the very best, coaching individuals, teams, and communities to higher levels of performance. And we've done it all by pioneering and leveraging sports science and proprietary tools across mindset, nutrition, movement, and recovery. Today, EXOS employs more than 4,000 people in over 400 locations worldwide. With award-winning facilities, sports medicine clinics, technology, and services, EXOS connects people to the solutions they need. We provide comprehensive game plans, regardless of skill and sport, based on time-tested fundamentals and research in order to help people take control of their health and performance. EXOS is trusted by hundreds of clients including leaders in business, technology, health, community organizations, and world champions in sports. Now we're leaning into our rich heritage to move the brand forward. In 2020, EXOS founder and president Mark Verstegen brought on industry vet Sarah Robb O'Hagan as CEO to lead the company into its next chapter. Culturally, we promote and reward humility, one team and tenacity as some of our core values and we are committed to cultivating an inclusive work environment where all of our team members feel empowered to grow and bring their whole selves every day. We celebrate the diverse voices and perspectives of our team members, knowing that diversity of age, race, ethnicity, gender identity, sexual orientation, veteran status and national origin, among other social identities, drive innovation, belonging and fuel our work. Job Summary: Job Description: Responsibilities We're seeking a Group Exercise instructor to lead our fitness classes. As our new Group Exercise instructor you must be: * Enthusiastic about group exercise classes and enjoy creating and delivering new, fresh and innovative routines * Confident in your professionalism by reporting on-time with a positive attitude and a passion to motivate others * A professional who is collaborative and a flexible leader in and out of the studio The Ideal Candidate will have: * Minimum of one year of experience actively leading successful group exercise classes * Current nationally accredited group exercise certification (e.g. AFAA, ACE, ACSM, NETA) if necessary * Instructors teaching licensed/branded formats (e.g. Zumba, Yoga) must also be trained and licensed to teach those specific formats * Current CPR/AED certification (First Aid certification is strongly desired) To prevent the infection and spread of COVID-19, and as an integral part of its public health and safety measures, EXOS requires that all successful applicants shall be required to show proof of full vaccination by an FDA-approved COVID-19 vaccine before beginning employment, unless an exemption from this policy has been granted as an accommodation or otherwise. Applicants believing they need an accommodation of this policy because of a disability, sincerely-held religious belief, or otherwise should inform People Operations after an offer of employment is extended; please do not include any medical, genetic, or religious information on your application materials. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! We are an equal opportunity employer EXOS is proud to be an affirmative action / equal opportunity employer. All qualified applicants will receive consideration without regard to race, creed, gender, marital status, sexual orientation, citizenship status, color, religion, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws. EXOS provides reasonable accommodation to employees and applicants for employment who have disabilities. You may request reasonable accommodation, in writing, by reaching out to our People Operations department at: Attention: People Operations, Accommodations 2629 E. Rose Garden Ln. Phoenix, AZ 85050 Learn more here: * EEO is the Law * EEO is the Law Supplement
Machine Learning Scientist The simulation and molecular sciences group at Pfizer is seeking a data engineer to design and implement computational workflows to accelerate drug discovery. The successful candidate will help us leverage on-premise compute clusters and cloud computing environments to derive insights from Pfizer's proprietary data and external datasets and generate and score new drug candidates across small molecule, biologic, and mRNA-based therapy spaces. The ideal candidate will create and maintain optimal data pipeline architectures, propose, develop, and assist in the deployment of data pipelines, including deep generative models, graph convolutional neural networks and transformer architectures, that help drive decision making for drug designers and bench scientists across all of Pfizer's therapeutic areas and modalities as well as assemble large, complex data sets that meet functional/non-functional SMS business requirements. The candidate will also be encouraged to publish and present their work in reputed journals and conference/workshop venues. Basic Qualifications: BS in Computer Science, Statistics, Applied Mathematics, Computational Biology / Bioinformatics, Computational Chemistry / Cheminformatics, related technical discipline, or related practical experience. 2+ years' experience programming experience in Python. 2+ years' experience in software design, development, and algorithm-related solutions for production-grade systems using machine learning. Applied experience with major ML algorithms in either of natural language processing, computer vision, and information retrieval (CNNs, transformers, etc.) Preferred Qualifications: MS/PhD + 2 years of relevant work experience Experience with high performance computing (HPC) environments (SLURM/LSF/SGE schedulers) Familiarity with cloud computing platforms (AWS, Google Cloud, etc.) Practical experience with deep learning-based solutions Familiarity with cheminformatics toolkits (e.g. OpenEye, RDKit etc.) Experience in designing and productionizing large-scale distributed systems for machine learning models. Advanced working SQL knowledge and experience working with relational databases, query authoring (SQL) as well as working familiarity with a variety of databases. Experience with big data tools: Hadoop, Spark, Kafka, MQTT etc. Experience with deploying and managing models with Kubernetes for MLOps Experience with continuous integration and configuration management (git and GitHub, Gradle, Jenkins, etc). Experience with deploying ML/DL models at scale in production Passion and curiosity for data and proven ability to take ideas from research to production. Technologies We Use: Python, Java, C++, Slurm-based on-premise compute clusters, Google Cloud Platform, AWS, Docker, Singularity, Kubernetes Python (Numpy, Pandas, Dask, PyTorch, TensorFlow, sci-kit learn, RDKit, etc.) Additional Job Information: Relocation support available Eligible for employee referral bonus Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Information & Business Tech
06/25/2022
Full time
Machine Learning Scientist The simulation and molecular sciences group at Pfizer is seeking a data engineer to design and implement computational workflows to accelerate drug discovery. The successful candidate will help us leverage on-premise compute clusters and cloud computing environments to derive insights from Pfizer's proprietary data and external datasets and generate and score new drug candidates across small molecule, biologic, and mRNA-based therapy spaces. The ideal candidate will create and maintain optimal data pipeline architectures, propose, develop, and assist in the deployment of data pipelines, including deep generative models, graph convolutional neural networks and transformer architectures, that help drive decision making for drug designers and bench scientists across all of Pfizer's therapeutic areas and modalities as well as assemble large, complex data sets that meet functional/non-functional SMS business requirements. The candidate will also be encouraged to publish and present their work in reputed journals and conference/workshop venues. Basic Qualifications: BS in Computer Science, Statistics, Applied Mathematics, Computational Biology / Bioinformatics, Computational Chemistry / Cheminformatics, related technical discipline, or related practical experience. 2+ years' experience programming experience in Python. 2+ years' experience in software design, development, and algorithm-related solutions for production-grade systems using machine learning. Applied experience with major ML algorithms in either of natural language processing, computer vision, and information retrieval (CNNs, transformers, etc.) Preferred Qualifications: MS/PhD + 2 years of relevant work experience Experience with high performance computing (HPC) environments (SLURM/LSF/SGE schedulers) Familiarity with cloud computing platforms (AWS, Google Cloud, etc.) Practical experience with deep learning-based solutions Familiarity with cheminformatics toolkits (e.g. OpenEye, RDKit etc.) Experience in designing and productionizing large-scale distributed systems for machine learning models. Advanced working SQL knowledge and experience working with relational databases, query authoring (SQL) as well as working familiarity with a variety of databases. Experience with big data tools: Hadoop, Spark, Kafka, MQTT etc. Experience with deploying and managing models with Kubernetes for MLOps Experience with continuous integration and configuration management (git and GitHub, Gradle, Jenkins, etc). Experience with deploying ML/DL models at scale in production Passion and curiosity for data and proven ability to take ideas from research to production. Technologies We Use: Python, Java, C++, Slurm-based on-premise compute clusters, Google Cloud Platform, AWS, Docker, Singularity, Kubernetes Python (Numpy, Pandas, Dask, PyTorch, TensorFlow, sci-kit learn, RDKit, etc.) Additional Job Information: Relocation support available Eligible for employee referral bonus Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Information & Business Tech
Pfizer has an exciting career opportunity available in our Drug Safety Research organization at one of our four locations for a Global Pathologist. Bring your diverse experiences and work with world-class thinkers and leaders with world-class resources within an exceptional, science focused environment. The Global Pathologist will be a motivated, intellectual partner heavily involved in study design and evaluation in order to develop an understanding of drug mechanisms of action, biomarkers, toxicity, and their relevance to humans to further advance therapies for unmet medical needs. You will be supporting our therapeutic areas: Oncology, Rare Disease, Vaccines, Internal Medicine, and Inflammation and Immunology. The Global Pathologist will be managed and supported by a highly accomplished, board certified pathologist. Pathologists provide morphologic and mechanistic data interpretation and regulatory or scientific expertise to projects and programs from idea to loss of exclusivity. They also interpret clinical pathology data, other scientific endpoints, and diagnose microscopic and macroscopic changes in tissues from animals in investigative and regulatory studies used to support drug discovery, research and development. Pathologists may use a variety of ancillary aids and instrumentation (EM, IHC, in situ hybridization etc.) and may direct or oversee either regulatory or investigative studies as well as serve on disciplinary or interdisciplinary teams. ROLE RESPONSIBILITIES Perform all regulatory responsibilities in compliance with applicable regulatory standards. Provide Pathology expertise to Drug Safety by evaluating microscope slides, virtual/electronic images and data. Integrate data and present findings and interpretations in written and oral reports to peers, management, and regulatory agencies. Provide input on study design. Provide expert scientific review and oversight of pathology including internal and external peer-review and report review. Provide pathology expertise to teams that may extend from early research to late-stage development. Initiate, run, and/or interpret studies to determine CIR, CIS of targets or compounds and to evaluate models of disease. Lead or provide expertise to issues management teams or mechanistic studies. Establish new assays and technologies for mechanistic studies, biomarkers, and automation. In particular, support the oncology IHC lab locally as well as other investigative techniques. Consult with subject matter experts as necessary. Additional roles include serving as a representative on project teams in the capacity of either a drug development scientist or project team pathologist. BASIC QUALIFICATIONS D.V.M., V.M.D. degree with advanced education and training in Veterinary Pathology 1-5 Years of Pharmaceutical or relevant experience Demonstrated familiarity with compliance and regulatory standards in a pharmaceutical environment Demonstrated early to late stage pathology experience PREFERRED QUALIFICATIONS Formal training and/or certification in Veterinary Pathology (e.g. ACVP, JCVP, MRCPath, ECVP or equivalent); Strong industry experience in Toxicologic and/or Investigative Pathology; An ability to work collaboratively in a matrixed, multi-disciplinary environment. Other Job Details: Relocation Support Available Locations: Cambridge, MA is highly preferred; La Jolla, CA, Pearl River, NY or Groton, CT Eligible for Employee Referral Bonus Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development
06/25/2022
Full time
Pfizer has an exciting career opportunity available in our Drug Safety Research organization at one of our four locations for a Global Pathologist. Bring your diverse experiences and work with world-class thinkers and leaders with world-class resources within an exceptional, science focused environment. The Global Pathologist will be a motivated, intellectual partner heavily involved in study design and evaluation in order to develop an understanding of drug mechanisms of action, biomarkers, toxicity, and their relevance to humans to further advance therapies for unmet medical needs. You will be supporting our therapeutic areas: Oncology, Rare Disease, Vaccines, Internal Medicine, and Inflammation and Immunology. The Global Pathologist will be managed and supported by a highly accomplished, board certified pathologist. Pathologists provide morphologic and mechanistic data interpretation and regulatory or scientific expertise to projects and programs from idea to loss of exclusivity. They also interpret clinical pathology data, other scientific endpoints, and diagnose microscopic and macroscopic changes in tissues from animals in investigative and regulatory studies used to support drug discovery, research and development. Pathologists may use a variety of ancillary aids and instrumentation (EM, IHC, in situ hybridization etc.) and may direct or oversee either regulatory or investigative studies as well as serve on disciplinary or interdisciplinary teams. ROLE RESPONSIBILITIES Perform all regulatory responsibilities in compliance with applicable regulatory standards. Provide Pathology expertise to Drug Safety by evaluating microscope slides, virtual/electronic images and data. Integrate data and present findings and interpretations in written and oral reports to peers, management, and regulatory agencies. Provide input on study design. Provide expert scientific review and oversight of pathology including internal and external peer-review and report review. Provide pathology expertise to teams that may extend from early research to late-stage development. Initiate, run, and/or interpret studies to determine CIR, CIS of targets or compounds and to evaluate models of disease. Lead or provide expertise to issues management teams or mechanistic studies. Establish new assays and technologies for mechanistic studies, biomarkers, and automation. In particular, support the oncology IHC lab locally as well as other investigative techniques. Consult with subject matter experts as necessary. Additional roles include serving as a representative on project teams in the capacity of either a drug development scientist or project team pathologist. BASIC QUALIFICATIONS D.V.M., V.M.D. degree with advanced education and training in Veterinary Pathology 1-5 Years of Pharmaceutical or relevant experience Demonstrated familiarity with compliance and regulatory standards in a pharmaceutical environment Demonstrated early to late stage pathology experience PREFERRED QUALIFICATIONS Formal training and/or certification in Veterinary Pathology (e.g. ACVP, JCVP, MRCPath, ECVP or equivalent); Strong industry experience in Toxicologic and/or Investigative Pathology; An ability to work collaboratively in a matrixed, multi-disciplinary environment. Other Job Details: Relocation Support Available Locations: Cambridge, MA is highly preferred; La Jolla, CA, Pearl River, NY or Groton, CT Eligible for Employee Referral Bonus Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development
Our mission at is to reduce global carbon emissions by making homes smart and efficient. We're serious about having a real impact on climate change by empowering people to easily take care of their homes and to actively participate in a cleaner, more resilient future. As we grow, the Sense team is seeking a passionate product manager to work with our strategic partners to bring the award-winning Sense home energy app and experience to new customers, new markets, and new hardware platforms. We want Sense to be available in every home, and to get there, Sense should be available both through our consumer product but also as software running on existing energy infrastructure in the home. As product manager you will be instrumental in helping us realize this vision. You will work with our partners to bring Sense to new platforms and develop new experiences made possible by those partners. You will be responsible for every step of the product life cycle from requirements to post-launch analysis, working with our partners to drive new features and product development. Responsibilities Own delivery of the Sense product through our strategic partners Discover, prioritize, and write requirements for new product features Work with our partners to identify new market opportunities and manage the partner product roadmap Lead the full product lifecycle: discovery, research, design, development, launch, and iteration Advocate for our users and partners, deeply understand their needs and pain points, and guide the roadmap accordingly Requirements 3+ years of product management experience Strong analytical and problem-solving skills, with focus on metrics-driven action Passion for UX and building products that customers love Ability to distill high level objectives and market feedback into clear, detailed product roadmaps and definitions Experience working directly with design and engineering teams Consulting or client-facing work experience Exceptional interpersonal and communication skills Excitement for and the ability to thrive in high growth, rapidly changing environments Nice to haves Consumer, mobile, or hardware product management experience MBA or similar graduate business degree Why Sense Sense supports a diverse and inclusive workplace where we learn from each other. We welcome candidates with backgrounds that are traditionally underrepresented in tech, and we strive to foster an engaging, respectful and supportive community where everyone feels empowered to do their best work. Sense is committed to being an equal opportunity employer. Sense is a growing VC-backed startup with an experienced leadership team and revolutionary machine learning technology. Best Startups in Cambridge - Tech Tribune "One of the world's top 100 AI companies" - VentureBeat Clean Tech Company of the Year - New England Venture Capital Association 50 on Fire - BostInno Top 100 - Red Herring Best Consumer AI Technology - AI Dev World Global Cleantech 100 Benefits Competitive compensation including equity Remote-friendly Remote or local/hybrid in our Cambridge Central Square office Home office setup allowance ($200/year) Great work-life balance Flexible work hours Vacation starting at 3 weeks/year + 1 week paid sick time Paid parental leave (5 weeks or more depending on location) Dependent Care Accounts Generous healthcare benefits for employees and dependents Medical (90% of the premium and first 50% of the deductible) Dental (90%) Vision (100%) Flexible Spending Accounts Life, AD&D, long- and short-term disability insurance (100%) 401k plan Free Sense energy monitor for your home, discounts for friends and family
06/25/2022
Full time
Our mission at is to reduce global carbon emissions by making homes smart and efficient. We're serious about having a real impact on climate change by empowering people to easily take care of their homes and to actively participate in a cleaner, more resilient future. As we grow, the Sense team is seeking a passionate product manager to work with our strategic partners to bring the award-winning Sense home energy app and experience to new customers, new markets, and new hardware platforms. We want Sense to be available in every home, and to get there, Sense should be available both through our consumer product but also as software running on existing energy infrastructure in the home. As product manager you will be instrumental in helping us realize this vision. You will work with our partners to bring Sense to new platforms and develop new experiences made possible by those partners. You will be responsible for every step of the product life cycle from requirements to post-launch analysis, working with our partners to drive new features and product development. Responsibilities Own delivery of the Sense product through our strategic partners Discover, prioritize, and write requirements for new product features Work with our partners to identify new market opportunities and manage the partner product roadmap Lead the full product lifecycle: discovery, research, design, development, launch, and iteration Advocate for our users and partners, deeply understand their needs and pain points, and guide the roadmap accordingly Requirements 3+ years of product management experience Strong analytical and problem-solving skills, with focus on metrics-driven action Passion for UX and building products that customers love Ability to distill high level objectives and market feedback into clear, detailed product roadmaps and definitions Experience working directly with design and engineering teams Consulting or client-facing work experience Exceptional interpersonal and communication skills Excitement for and the ability to thrive in high growth, rapidly changing environments Nice to haves Consumer, mobile, or hardware product management experience MBA or similar graduate business degree Why Sense Sense supports a diverse and inclusive workplace where we learn from each other. We welcome candidates with backgrounds that are traditionally underrepresented in tech, and we strive to foster an engaging, respectful and supportive community where everyone feels empowered to do their best work. Sense is committed to being an equal opportunity employer. Sense is a growing VC-backed startup with an experienced leadership team and revolutionary machine learning technology. Best Startups in Cambridge - Tech Tribune "One of the world's top 100 AI companies" - VentureBeat Clean Tech Company of the Year - New England Venture Capital Association 50 on Fire - BostInno Top 100 - Red Herring Best Consumer AI Technology - AI Dev World Global Cleantech 100 Benefits Competitive compensation including equity Remote-friendly Remote or local/hybrid in our Cambridge Central Square office Home office setup allowance ($200/year) Great work-life balance Flexible work hours Vacation starting at 3 weeks/year + 1 week paid sick time Paid parental leave (5 weeks or more depending on location) Dependent Care Accounts Generous healthcare benefits for employees and dependents Medical (90% of the premium and first 50% of the deductible) Dental (90%) Vision (100%) Flexible Spending Accounts Life, AD&D, long- and short-term disability insurance (100%) 401k plan Free Sense energy monitor for your home, discounts for friends and family
ROLE SUMMARY We are seeking a candidate specializing in lipid nanoparticle (LNP) formulation and characterization to work in the BioMedicine Design (BMD) line of the Medicinal Sciences Organization. In this role the candidate will perform the generation and screening of novel LNP formulations. ROLE RESPONSIBILITIES Generate LNP formulations with novel components. Expected involvement in the design and execution of these studies and the ability to run experiments independently. Work collaboratively with analytical and production teams to ensure quality of all LNP formulations generated. Ability to independently analyze results and troubleshoot experiments. Presentation of results to project teams. BASIC QUALIFICATIONS BS Degree with 4+ or MS Degree with 2+ years experience in biochemistry, biophysics, analytical chemistry, chemical engineering, pharmaceutical science, or a related discipline. Hands on experience in laboratory research is required, preferably in biochemistry, analytical chemistry, drug discovery and development. Demonstrated ability to drive for results and capable of completing experiments with minimal supervision. Experience and good understanding on nanoparticle formulation/characterization, RNA biology/ stability. Experience with Microsoft PowerPoint and Excel for data analysis and presentation. Strong communication and documentation skills. Self-motivated, organized, capable of working independently, and in a collaborative environment. PREFERRED QUALIFICATIONS Prior experience in industry working on biopharmaceuticals and familiarity with the drug development process is desirable. Hands on experience with lipid nanoparticles preferred. PHYSICAL/MENTAL REQUIREMENTS N/A NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development
06/25/2022
Full time
ROLE SUMMARY We are seeking a candidate specializing in lipid nanoparticle (LNP) formulation and characterization to work in the BioMedicine Design (BMD) line of the Medicinal Sciences Organization. In this role the candidate will perform the generation and screening of novel LNP formulations. ROLE RESPONSIBILITIES Generate LNP formulations with novel components. Expected involvement in the design and execution of these studies and the ability to run experiments independently. Work collaboratively with analytical and production teams to ensure quality of all LNP formulations generated. Ability to independently analyze results and troubleshoot experiments. Presentation of results to project teams. BASIC QUALIFICATIONS BS Degree with 4+ or MS Degree with 2+ years experience in biochemistry, biophysics, analytical chemistry, chemical engineering, pharmaceutical science, or a related discipline. Hands on experience in laboratory research is required, preferably in biochemistry, analytical chemistry, drug discovery and development. Demonstrated ability to drive for results and capable of completing experiments with minimal supervision. Experience and good understanding on nanoparticle formulation/characterization, RNA biology/ stability. Experience with Microsoft PowerPoint and Excel for data analysis and presentation. Strong communication and documentation skills. Self-motivated, organized, capable of working independently, and in a collaborative environment. PREFERRED QUALIFICATIONS Prior experience in industry working on biopharmaceuticals and familiarity with the drug development process is desirable. Hands on experience with lipid nanoparticles preferred. PHYSICAL/MENTAL REQUIREMENTS N/A NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development
Head of Cell Therapy CMC Process Development Job Scope & Purpose: This position is responsible for leading the CMC Process Development and Analytics for both clinical phase and commercial phase cell therapies at a transformative and innovative emerging cell therapy focused biotech. This collaborative leader will partner with key stakeholders across the organization to define and drive a holistic CMC technical strategy that collects, organizes, and leverages product and process knowledge thru the full manufacturing value stream in alignment with relevant regulatory guidelines and cell therapy industry best practices. This person will provide scientific leadership, strategic thinking, and results focus to reliably meet and/or exceed the company's CMC goals while supporting high levels of quality. This position requires an individual capable of identifying and implementing innovative technical strategies in support of delivering transformative therapies to patients. Primary Job Requirements: BS or MS and 10+ years of relevant work experience- PhD preferred Minimum of 8 years leading development / technology teams in fast paced environments Expertise in development and manufacturing of cell and or gene therapy products Exceptional ability to compile, analyze, and interpret quantitative data and facts Strong troubleshooting and problem solving skills and the ability to drive timely fact based decisions Excellent written and oral communication skills both internal and external Ability to own and navigate cGMP manufacturing areas About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code:TechOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
06/25/2022
Full time
Head of Cell Therapy CMC Process Development Job Scope & Purpose: This position is responsible for leading the CMC Process Development and Analytics for both clinical phase and commercial phase cell therapies at a transformative and innovative emerging cell therapy focused biotech. This collaborative leader will partner with key stakeholders across the organization to define and drive a holistic CMC technical strategy that collects, organizes, and leverages product and process knowledge thru the full manufacturing value stream in alignment with relevant regulatory guidelines and cell therapy industry best practices. This person will provide scientific leadership, strategic thinking, and results focus to reliably meet and/or exceed the company's CMC goals while supporting high levels of quality. This position requires an individual capable of identifying and implementing innovative technical strategies in support of delivering transformative therapies to patients. Primary Job Requirements: BS or MS and 10+ years of relevant work experience- PhD preferred Minimum of 8 years leading development / technology teams in fast paced environments Expertise in development and manufacturing of cell and or gene therapy products Exceptional ability to compile, analyze, and interpret quantitative data and facts Strong troubleshooting and problem solving skills and the ability to drive timely fact based decisions Excellent written and oral communication skills both internal and external Ability to own and navigate cGMP manufacturing areas About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code:TechOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Integrated Resources, Inc.
Cambridge, Massachusetts
Job Description Job Title:Senior Scientist Location:Cambridge, MA Duration: 12+ months Job Responsibilities: This is an excellent opportunity to help make a difference using your bioanalytical experience to further develop key skills in metabolomics applied to drug discovery. The successful candidate will Product valuable exposure to a variety of biological projects, interacting with a cross-functional team at the Client Cambridge Exploratory Science site. In lab you will use a combination of manual and automated liquid dispensing approaches to process biological samples, extract metabolites from various biological matrixes: cell culture, tissues, and biofluids such as plasma/serum; acquire and analyze data generated on high resolution, accurate mass LC/MS and LC/MS/MS instruments. Working closely together with the team, interpret metabolomics data using various statistical and visualization tools, and summarize results to help with communication to additional stakeholders. You will need to ensure accurate and consistent data analysis, documenting in an ELN, assist with keeping the instruments running, follow laboratory and safety protocols, help with routine instrument maintenance, as well as writing/reporting will be part of daily activities. Training will be provided where needed. Qualifications: We are seeking a contractor (for one year with possibility of extending to two years) with bioanalytical and wet bench laboratory experience, who is also familiar with and can support the team with data analysis. Minimum M.S. in a science related field: Chemistry, Biochemistry, Life Sciences, Molecular Biology, Bioanalytical or related field with 3-5years of relevant experience A PhD degree with at least 1 year of experience in a bioanalytical role acquiring and analyzing metabolomics data. Familiar with using Agilent Mass Hunter software Is capable of operating one or more of the following LC/MS instruments: uHPLC/ Q-TOF, TOF and QQQ. Experience with GC/MS or Thermo Orbitrap is a plus Familiar with using both public and vendor supplied mass spectrometry software for processing, analyzing and annotating metabolomics data. Some experience querying the published literature to help interpret mass spectrometry results Automated Liquid handling experience (such as Biomek FX) is a plus General molecular biology skills, cell culture and correct handling of organic solvent Follows Good Laboratory Practices and adheres to chemical and biological laboratory safety guidelines. Preferred: Previous experience extracting small molecule metabolites from various biological matrixes. Basic understanding of Statistics A background in biology and biochemistry Knowledge. Skills, Abilities: Multi-task effectively and prioritize multiple projects under guidance. Willingness to learn and adopt new experimental skills as needed Ability to analyze, interpret and summarize scientific results in a clear, concise, and accurate manner Experienced with using Microsoft Office. Familiarity with using GraphPad Prism, Spotfire and/or some programming skills (R or Python) is a plus Excellent verbal and written communication skills Personality. 1 year role, possibility of extension Onsite in Cambridge, MA.
06/25/2022
Full time
Job Description Job Title:Senior Scientist Location:Cambridge, MA Duration: 12+ months Job Responsibilities: This is an excellent opportunity to help make a difference using your bioanalytical experience to further develop key skills in metabolomics applied to drug discovery. The successful candidate will Product valuable exposure to a variety of biological projects, interacting with a cross-functional team at the Client Cambridge Exploratory Science site. In lab you will use a combination of manual and automated liquid dispensing approaches to process biological samples, extract metabolites from various biological matrixes: cell culture, tissues, and biofluids such as plasma/serum; acquire and analyze data generated on high resolution, accurate mass LC/MS and LC/MS/MS instruments. Working closely together with the team, interpret metabolomics data using various statistical and visualization tools, and summarize results to help with communication to additional stakeholders. You will need to ensure accurate and consistent data analysis, documenting in an ELN, assist with keeping the instruments running, follow laboratory and safety protocols, help with routine instrument maintenance, as well as writing/reporting will be part of daily activities. Training will be provided where needed. Qualifications: We are seeking a contractor (for one year with possibility of extending to two years) with bioanalytical and wet bench laboratory experience, who is also familiar with and can support the team with data analysis. Minimum M.S. in a science related field: Chemistry, Biochemistry, Life Sciences, Molecular Biology, Bioanalytical or related field with 3-5years of relevant experience A PhD degree with at least 1 year of experience in a bioanalytical role acquiring and analyzing metabolomics data. Familiar with using Agilent Mass Hunter software Is capable of operating one or more of the following LC/MS instruments: uHPLC/ Q-TOF, TOF and QQQ. Experience with GC/MS or Thermo Orbitrap is a plus Familiar with using both public and vendor supplied mass spectrometry software for processing, analyzing and annotating metabolomics data. Some experience querying the published literature to help interpret mass spectrometry results Automated Liquid handling experience (such as Biomek FX) is a plus General molecular biology skills, cell culture and correct handling of organic solvent Follows Good Laboratory Practices and adheres to chemical and biological laboratory safety guidelines. Preferred: Previous experience extracting small molecule metabolites from various biological matrixes. Basic understanding of Statistics A background in biology and biochemistry Knowledge. Skills, Abilities: Multi-task effectively and prioritize multiple projects under guidance. Willingness to learn and adopt new experimental skills as needed Ability to analyze, interpret and summarize scientific results in a clear, concise, and accurate manner Experienced with using Microsoft Office. Familiarity with using GraphPad Prism, Spotfire and/or some programming skills (R or Python) is a plus Excellent verbal and written communication skills Personality. 1 year role, possibility of extension Onsite in Cambridge, MA.
What You Will Achieve Pfizer's Rare Disease Research Unit (RDRU) is focused on developing therapeutic solutions for patients with rare disorders. The successful candidate will be an integral part of an interdisciplinary team to execute preclinical studies to expand Pfizer's gene editing portfolio. This role will focus on the implementation of pre-clinical cellular assays to characterize potential therapies. The senior associate scientist will make significant technical contributions to multiple projects using established methodologies while being encouraged to learn and incorporate novel approaches. How You Will Achieve It Utilize standard operation procedures to generate and interpret data for presentation to the gene editing team. Under the guidance of the team, learn and implement new techniques. Manage their time and resources to execute projects with multiple team members. Independently stay up-to-date on the relevant technology Qualifications Must-Have Bachelor's Degree with 4+ years laboratory experience or a Master's degree with 2+ years of laboratory experience. Experience with basic molecular biology techniques such as: plasmid cloning, Western blotting, RNA/DNA extraction, PCR, reverse-transcription, or real-time qPCR. Strong experience in cell culture and sterile technique. Adaptability and a positive "do-what-it-takes" attitude. Strong communication and interpersonal skills. Desire and drive to learn. Nice-to-Have Experience in an industry or pharmaceutical setting. Expertise with primary cell culture. Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development
06/25/2022
Full time
What You Will Achieve Pfizer's Rare Disease Research Unit (RDRU) is focused on developing therapeutic solutions for patients with rare disorders. The successful candidate will be an integral part of an interdisciplinary team to execute preclinical studies to expand Pfizer's gene editing portfolio. This role will focus on the implementation of pre-clinical cellular assays to characterize potential therapies. The senior associate scientist will make significant technical contributions to multiple projects using established methodologies while being encouraged to learn and incorporate novel approaches. How You Will Achieve It Utilize standard operation procedures to generate and interpret data for presentation to the gene editing team. Under the guidance of the team, learn and implement new techniques. Manage their time and resources to execute projects with multiple team members. Independently stay up-to-date on the relevant technology Qualifications Must-Have Bachelor's Degree with 4+ years laboratory experience or a Master's degree with 2+ years of laboratory experience. Experience with basic molecular biology techniques such as: plasmid cloning, Western blotting, RNA/DNA extraction, PCR, reverse-transcription, or real-time qPCR. Strong experience in cell culture and sterile technique. Adaptability and a positive "do-what-it-takes" attitude. Strong communication and interpersonal skills. Desire and drive to learn. Nice-to-Have Experience in an industry or pharmaceutical setting. Expertise with primary cell culture. Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Research and Development
Job Overview: The Scrum Master is a servant leader and coach for a Pod (Agile Product Team). The ideal candidate will need to bring leadership skills, vision, communication skills, passion and understanding of medical device software development. (S)He helps educate the Pod in Scrum and, where relevant, Agile at scale practices, ensuring that the agreed Agile process is being followed. (S)He also helps remove impediments and foster an environment for high-performing team dynamics, continuous flow, and relentless improvement. Responsibilities: Evangelize the organization on the value of Agile, ensure that Agile principles are being implemented, coach individual team members to ensure each are following SCRUM roles, and provide regular visibility into the backlog, progress being made, and where the team are going. Facilitate Product release plan creation and its execution with cross-functional team consisting of engineering, quality, risk manager, medical, regulatory, human factors, and legal. Drives the delivery of Class I and II software medical device products and corresponding design control documentation. Support internal and external quality audits for the ongoing and launched products. Facilitates agile ceremonies throughout each sprint (daily standup, sprint planning, sprint demos, retrospectives, and backlog refinements). Helps the agile teams to work in an autonomous way and continuous improvement spirit, to identify and formalize obstacles and fix them. Helps the Product Owner in his/her efforts to manage the backlog and guide the team while facilitating a healthy team dynamic with respect to priorities and scope. Communicates with management and outside stakeholders; helps protect the team from uncontrolled expansion of work. Organizes training sessions to promote and master agility practices, Facilitates all conversations and sessions with the larger group around Epic and/or Initiative discovery, priorities, requirements, dependencies, inter-team cooperation. Helps the team embrace agile at scale process led by the Master Scrum Master and implement practices. Leverages agile tracker tools (like Jira). Job Specific Skills and Competencies Project Management Compliance of computerized systems (Intermediate ) IT strategy & Governance Lead & Agile Practices User Experience Software Medical Device Development (Design Controls, ISO 13485, IEC 62304, 21 Code of Federal Regulations Part 820.30) Compliance of quality Management Systems Transversal Skills and Competencies Business Partnership Interpersonal Communication Transverse Collaboration Strategic Thinking Decision Making Change Management Additional soft skills: Servant leadership mindset, facilitation, situational awareness, conflict resolution, continuous improvement, empowerment, and increasing transparency. Job Qualifications: BS in Computer Science or equivalent 10+ years of experience with Agile / Scrum and Project Management Certified Scrum Master Experience in Agile software development for Software Medical Devices Excellent verbal and written communication skills. Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problems solving skills 5+ years of experience in Software Medical Devices development that follows ISO 13485, IEC 62304 / 21 CFR Part 820.30 Proven record of accomplishment of being a strong team player As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
06/25/2022
Full time
Job Overview: The Scrum Master is a servant leader and coach for a Pod (Agile Product Team). The ideal candidate will need to bring leadership skills, vision, communication skills, passion and understanding of medical device software development. (S)He helps educate the Pod in Scrum and, where relevant, Agile at scale practices, ensuring that the agreed Agile process is being followed. (S)He also helps remove impediments and foster an environment for high-performing team dynamics, continuous flow, and relentless improvement. Responsibilities: Evangelize the organization on the value of Agile, ensure that Agile principles are being implemented, coach individual team members to ensure each are following SCRUM roles, and provide regular visibility into the backlog, progress being made, and where the team are going. Facilitate Product release plan creation and its execution with cross-functional team consisting of engineering, quality, risk manager, medical, regulatory, human factors, and legal. Drives the delivery of Class I and II software medical device products and corresponding design control documentation. Support internal and external quality audits for the ongoing and launched products. Facilitates agile ceremonies throughout each sprint (daily standup, sprint planning, sprint demos, retrospectives, and backlog refinements). Helps the agile teams to work in an autonomous way and continuous improvement spirit, to identify and formalize obstacles and fix them. Helps the Product Owner in his/her efforts to manage the backlog and guide the team while facilitating a healthy team dynamic with respect to priorities and scope. Communicates with management and outside stakeholders; helps protect the team from uncontrolled expansion of work. Organizes training sessions to promote and master agility practices, Facilitates all conversations and sessions with the larger group around Epic and/or Initiative discovery, priorities, requirements, dependencies, inter-team cooperation. Helps the team embrace agile at scale process led by the Master Scrum Master and implement practices. Leverages agile tracker tools (like Jira). Job Specific Skills and Competencies Project Management Compliance of computerized systems (Intermediate ) IT strategy & Governance Lead & Agile Practices User Experience Software Medical Device Development (Design Controls, ISO 13485, IEC 62304, 21 Code of Federal Regulations Part 820.30) Compliance of quality Management Systems Transversal Skills and Competencies Business Partnership Interpersonal Communication Transverse Collaboration Strategic Thinking Decision Making Change Management Additional soft skills: Servant leadership mindset, facilitation, situational awareness, conflict resolution, continuous improvement, empowerment, and increasing transparency. Job Qualifications: BS in Computer Science or equivalent 10+ years of experience with Agile / Scrum and Project Management Certified Scrum Master Experience in Agile software development for Software Medical Devices Excellent verbal and written communication skills. Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problems solving skills 5+ years of experience in Software Medical Devices development that follows ISO 13485, IEC 62304 / 21 CFR Part 820.30 Proven record of accomplishment of being a strong team player As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Apply Description The Forsyth Institute is a world leader in the field of Dental and Craniofacial Research. Located in the Cambridge area, an epicenter of biomedical research, the campus is with one of the highest densities of colleges and innovations and offers collaboration with various preeminent academic institutions, hospitals, research institutes, and biotech and pharmaceutical companies. Craniofacial and Skeletal Biology is seeking two candidates to join this vibrant group to study developmental and stem cell biology, regenerative medicine, congenital birth defects, and aging-related disorders. Priority will be given to candidates with expertise in developmental genetics, molecular and cell biology, microRNA, posttranslational modification, ciliogenesis, and biomedical engineering. Research experience in craniofacial and skeletal biology is a plus but not required for these positions. The research studies focus on the elucidation of molecular and cellular mechanisms underlying stem cell self-renewal, cell fate determination and differentiation, crosstalk of signaling pathways, tissue repair and regeneration, and stem cell-based and gene-editing therapies. Motivated individuals with high enthusiasms to learn and advance the field are encouraged to formally apply (below). For additional inquiries, please contact Dr. Wei Hsu, Senior Member of the Staff, Forsyth Institute, Co-Director, Center for Craniofacial and Skeletal Biology: email: Specific Responsibilities * Research involves the use of various techniques in mouse genetics, tissue harvest and dissection, histology, cell culture, molecular cloning, transplantation study, injury repair, and regeneration * Technical troubleshooting includes but not limited to the area of PCR genotyping and qPCR, lentivirus-mediated gene expression, microscopes and digital imaging techniques, and phenotypic characterizations of genetically modified mouse mutants * Research also involves micro CT imaging and characterization of new mouse genetic models * Mouse colony management as necessary Basic Qualifications * Ph.D. or equivalent in Biomedical Science related fields * Record of 2-4 years of experience in the board area of biology * Experience in the hypothesis-driven research project * Knowledge in cell culture and animal handling * Excellent analytical, problem solving, and technical skills * Good interpersonal and communication skills * Willing to work in a collaborative environment * High motivation and responsibility Preferred Qualifications * Direct hands-on experience with mouse genetics, developmental and stem cell biology * Bioinformatics, 3D image reconstruction/rendering * Craniofacial or Skeletal Biology * Bioengeneering/Biomedical Engineering To Apply Forsyth provides competitive salaries and a comprehensive benefits program. Qualified and interested applicants are encouraged to apply for immediate consideration. The Forsyth Institute is 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.
06/25/2022
Full time
Apply Description The Forsyth Institute is a world leader in the field of Dental and Craniofacial Research. Located in the Cambridge area, an epicenter of biomedical research, the campus is with one of the highest densities of colleges and innovations and offers collaboration with various preeminent academic institutions, hospitals, research institutes, and biotech and pharmaceutical companies. Craniofacial and Skeletal Biology is seeking two candidates to join this vibrant group to study developmental and stem cell biology, regenerative medicine, congenital birth defects, and aging-related disorders. Priority will be given to candidates with expertise in developmental genetics, molecular and cell biology, microRNA, posttranslational modification, ciliogenesis, and biomedical engineering. Research experience in craniofacial and skeletal biology is a plus but not required for these positions. The research studies focus on the elucidation of molecular and cellular mechanisms underlying stem cell self-renewal, cell fate determination and differentiation, crosstalk of signaling pathways, tissue repair and regeneration, and stem cell-based and gene-editing therapies. Motivated individuals with high enthusiasms to learn and advance the field are encouraged to formally apply (below). For additional inquiries, please contact Dr. Wei Hsu, Senior Member of the Staff, Forsyth Institute, Co-Director, Center for Craniofacial and Skeletal Biology: email: Specific Responsibilities * Research involves the use of various techniques in mouse genetics, tissue harvest and dissection, histology, cell culture, molecular cloning, transplantation study, injury repair, and regeneration * Technical troubleshooting includes but not limited to the area of PCR genotyping and qPCR, lentivirus-mediated gene expression, microscopes and digital imaging techniques, and phenotypic characterizations of genetically modified mouse mutants * Research also involves micro CT imaging and characterization of new mouse genetic models * Mouse colony management as necessary Basic Qualifications * Ph.D. or equivalent in Biomedical Science related fields * Record of 2-4 years of experience in the board area of biology * Experience in the hypothesis-driven research project * Knowledge in cell culture and animal handling * Excellent analytical, problem solving, and technical skills * Good interpersonal and communication skills * Willing to work in a collaborative environment * High motivation and responsibility Preferred Qualifications * Direct hands-on experience with mouse genetics, developmental and stem cell biology * Bioinformatics, 3D image reconstruction/rendering * Craniofacial or Skeletal Biology * Bioengeneering/Biomedical Engineering To Apply Forsyth provides competitive salaries and a comprehensive benefits program. Qualified and interested applicants are encouraged to apply for immediate consideration. The Forsyth Institute is 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.
Do you have at least 3 mths exp in last 3 yrs? Has it been at 120 days since your failed or refused test,? Have you completed the SAP Return to Duty course? If so We want you. Due to the unpresidented driver demand we are temporarily taking SAP drivers. We currently have a dedicated regional home weekly positions available. This hiring window is only for a short time so if you have failed a dot drug or alcohol test or know someone that has then contact me immediately. YOU cannot just apply here you MUST CALL Charles at to get in on this offer This window will not be open long so call today and be ready to start asap.
06/25/2022
Full time
Do you have at least 3 mths exp in last 3 yrs? Has it been at 120 days since your failed or refused test,? Have you completed the SAP Return to Duty course? If so We want you. Due to the unpresidented driver demand we are temporarily taking SAP drivers. We currently have a dedicated regional home weekly positions available. This hiring window is only for a short time so if you have failed a dot drug or alcohol test or know someone that has then contact me immediately. YOU cannot just apply here you MUST CALL Charles at to get in on this offer This window will not be open long so call today and be ready to start asap.
Position Overview / Key Responsibilities: Competencies and expectations associated with this role include but are not limited to the following: Lead the Tolebrutinib US HCP marketing efforts for all potential MS indications (RRMS, PPMS, NR-SPMS) launch Continuous assessment and validation of brand differentiation and reasons to believe. Lead US execution of brand positioning and messaging. Lead US Unbranded and branded professional campaign execution. Lead HCP and manage 2 direct reports on the development of HCP field strategy and materials for both sales and TLLs Lead US execution on customer segmentation and implementation strategies. Development of the non-personal strategy across HCP segments. Compliantly engage with HCP thought leaders and analyze market research to understand brand challenges and opportunities, to influence perceptions, and to develop advocates. Lead marketing collaboration with Value Access and Market research teams. Close collaboration with global and cross functional partners (including legal, medical, regulatory, sales, TLLs and training). Close collaboration with consumer marketing and digital lead to ensure alignment and innovation opportunity for brand. Oversee PRB meetings and coordinate OPDP submission of launch materials for MS indications. Develop and maintain effective collaborative working relations with agency partners to ensure proper execution of HCP objectives and initiatives. Lead the development and management of the Tolebrutinib HCP marketing budget. Work effectively within the established corporate and industry compliance guidelines. Education/Experience Qualifications: Bachelor's degree and 4-8+ years' experience in product/brand management, and/or strategic marketing, commercial / business development in the pharmaceutical or biopharmaceutical industries. A comprehensive understanding of the key dynamics driving the US health care environment. Ability to quickly understand and communicate all clinical data / publications to support business objectives. Understanding of market research, creative development, and experience with the regulatory review/approval process Ability to interact widely and effectively both within the company and with cross-functional partners (i.e., on an interdepartmental and interdisciplinary basis). Preferred Qualifications: Demonstrated ability to understand and anticipate customer needs (internal and/or external). Strong project management skills. Exceptional communication and presentation skills. Experience managing an advertising agency and related budgets. Demonstrated analytical skills. Passionate, confident, articulate, and comfortable in a team environment. US pharmaceutical marketing and/or launch experience preferred. US Pharma sales experience. Professional Skills & Behavioral Competencies: Excellent organizational, interpersonal, presentation and communication skills with the ability to communicate and present to different levels in the organization. Ability to lead in an ambiguous environment across different functions and company cultures. Strategic thinking and prioritizing capacity. Analytic and synthesis capacity with the ability to understand, simplify and communicate effectively with others. Demonstrated ability to work effectively with cross-functional groups. Ability to think creatively and lead innovative projects. Performance orientation and ability to drive, work and deliver along agreed timelines. Team oriented. Willingness to go the extra mile. Readiness to travel (up to 40% of time). As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
06/25/2022
Full time
Position Overview / Key Responsibilities: Competencies and expectations associated with this role include but are not limited to the following: Lead the Tolebrutinib US HCP marketing efforts for all potential MS indications (RRMS, PPMS, NR-SPMS) launch Continuous assessment and validation of brand differentiation and reasons to believe. Lead US execution of brand positioning and messaging. Lead US Unbranded and branded professional campaign execution. Lead HCP and manage 2 direct reports on the development of HCP field strategy and materials for both sales and TLLs Lead US execution on customer segmentation and implementation strategies. Development of the non-personal strategy across HCP segments. Compliantly engage with HCP thought leaders and analyze market research to understand brand challenges and opportunities, to influence perceptions, and to develop advocates. Lead marketing collaboration with Value Access and Market research teams. Close collaboration with global and cross functional partners (including legal, medical, regulatory, sales, TLLs and training). Close collaboration with consumer marketing and digital lead to ensure alignment and innovation opportunity for brand. Oversee PRB meetings and coordinate OPDP submission of launch materials for MS indications. Develop and maintain effective collaborative working relations with agency partners to ensure proper execution of HCP objectives and initiatives. Lead the development and management of the Tolebrutinib HCP marketing budget. Work effectively within the established corporate and industry compliance guidelines. Education/Experience Qualifications: Bachelor's degree and 4-8+ years' experience in product/brand management, and/or strategic marketing, commercial / business development in the pharmaceutical or biopharmaceutical industries. A comprehensive understanding of the key dynamics driving the US health care environment. Ability to quickly understand and communicate all clinical data / publications to support business objectives. Understanding of market research, creative development, and experience with the regulatory review/approval process Ability to interact widely and effectively both within the company and with cross-functional partners (i.e., on an interdepartmental and interdisciplinary basis). Preferred Qualifications: Demonstrated ability to understand and anticipate customer needs (internal and/or external). Strong project management skills. Exceptional communication and presentation skills. Experience managing an advertising agency and related budgets. Demonstrated analytical skills. Passionate, confident, articulate, and comfortable in a team environment. US pharmaceutical marketing and/or launch experience preferred. US Pharma sales experience. Professional Skills & Behavioral Competencies: Excellent organizational, interpersonal, presentation and communication skills with the ability to communicate and present to different levels in the organization. Ability to lead in an ambiguous environment across different functions and company cultures. Strategic thinking and prioritizing capacity. Analytic and synthesis capacity with the ability to understand, simplify and communicate effectively with others. Demonstrated ability to work effectively with cross-functional groups. Ability to think creatively and lead innovative projects. Performance orientation and ability to drive, work and deliver along agreed timelines. Team oriented. Willingness to go the extra mile. Readiness to travel (up to 40% of time). As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Senior Director, GxP QA (Biologics) Job Scope & Purpose: Our expanding biotech client is making a difference in the fight to understand and stop cancer. We're on the hunt for a head of QA who will oversee the expansion of the quality system as the company prepares for inspection readiness. You will collaborate internally and externally leading a cross functional team to provide oversight of Quality efforts ensuring GxP practices are implemented and followed in accordance with cGMP, Google Cloud Platform and GLP standards. This opportunity has the flexibility to be hybrid and is based out of Cambridge, MA. Primary Job Responsibilities: Lead the development of GxP quality infrastructure needed to support late stage clinical and commercial/launch using external CDMO's and CTL's Manage vendor qualification and audit programs Manage and mentor existing QA personnel and plan for the growth of the department and quality program. Perform quality assurance activities associated with cGMP manufacturing, investigations, change control, investigations, and documentation. Participate in batch release including the review of batch records, QC testing, SOPs, and other batch related documentation and lot release data. Lead training and implementation of GXP procedures and quality systems. Primary Job Requirements: BS/ MS with 10+ years of GxP Quality compliance experience managing and implementing Quality Systems Experience in the implementation and maintenance of GxP quality systems including auditing and vendor qualification Knowledgeable in managing GMP compliance at outsourced manufacturing sites Strong understanding of GMPs as they apply to early development and commercial products Previous BLA experience is required About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code:TechOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
06/25/2022
Full time
Senior Director, GxP QA (Biologics) Job Scope & Purpose: Our expanding biotech client is making a difference in the fight to understand and stop cancer. We're on the hunt for a head of QA who will oversee the expansion of the quality system as the company prepares for inspection readiness. You will collaborate internally and externally leading a cross functional team to provide oversight of Quality efforts ensuring GxP practices are implemented and followed in accordance with cGMP, Google Cloud Platform and GLP standards. This opportunity has the flexibility to be hybrid and is based out of Cambridge, MA. Primary Job Responsibilities: Lead the development of GxP quality infrastructure needed to support late stage clinical and commercial/launch using external CDMO's and CTL's Manage vendor qualification and audit programs Manage and mentor existing QA personnel and plan for the growth of the department and quality program. Perform quality assurance activities associated with cGMP manufacturing, investigations, change control, investigations, and documentation. Participate in batch release including the review of batch records, QC testing, SOPs, and other batch related documentation and lot release data. Lead training and implementation of GXP procedures and quality systems. Primary Job Requirements: BS/ MS with 10+ years of GxP Quality compliance experience managing and implementing Quality Systems Experience in the implementation and maintenance of GxP quality systems including auditing and vendor qualification Knowledgeable in managing GMP compliance at outsourced manufacturing sites Strong understanding of GMPs as they apply to early development and commercial products Previous BLA experience is required About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code:TechOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Greystar Real Estate Partners LLC
Cambridge, Massachusetts
Manages the day-to-day operations of an assigned property including managing the team members, daily activities, and resources of the property to achieve established budgeted financial and operational goals, and ensures that the operation of the property complies with Company policies and procedures, Fair Housing, Americans with Disabilities Act, Fair Credit Reporting Act, and other laws and regulations governing multi-family housing operations. JOB DESCRIPTION Position will include travel in/around the greater Boston area to assist and support the day to day operations of various communities to meet the needs of the organization. Provides input into the development of budget(s) for the property by analyzing and evaluating financial statements, reviewing current and projected marketing information, and accessing operational reports that establish historic and predict performance patterns. Meets targeted revenues by setting rent rates, ensuring rent and fees are collected and posted in a timely manner, making financial bank deposits, and preparing and reviewing monthly financial status reports. Approves invoices from vendors, contractors, and service providers for payment by reconciling work performed or products purchased, ensuring validity of certificates of insurance, coding charges to appropriate Chart of Account codes, and managing communication between the vendor/contractor, accounting, and the client/owner as needed. Controls expenditures by staying within the constraints of the approved budget and manages the balance and maintenance of the petty cash fund. Oversees the lease enforcement process by approving prospective resident applications, discounts and renewal leases, conducts periodic apartment inspections, follows proper notice requirements, evicts residents, and imposes and collects late fees and other charges as allowable and stated in the terms of the lease. Gathers, analyzes, and interprets current market and economic trends that may impact the property and implements short- and long-range marketing and leasing strategies to achieve the property's occupancy and revenue goals. Promotes resident satisfaction and retention by responding to complaints, questions, and requests in a timely manner, and taking appropriate action to resolve and address service issues. Ensures the property's maintenance team members comply with the Company's standards with respect to responding and completing resident service requests. Conducts regular property inspections and takes appropriate actions to ensure that the physical aspects of the property, grounds, buildings, and amenities meet established standards for safety, cleanliness, and general appearance and appeal. Community Manager Supervises property staff by interviewing, hiring, orienting, and training employees, and manages their performance in accordance with Company policies, values, and business practices. Assists in managing the client/owner relationship by meeting with the owners, conducting property tours, providing updates and information about the property's performance, and responding to owner requests as needed. Depending on the position offered, regular full-time and part-time team members may be eligible to participate in a bonus program in addition to their base salary. Once eligible, team members may participate in the 401k plan. Regular, full-time team members are also offered a range of medical, financial, and/or other benefits from which to choose. Greystar will consider for employment qualified applicants with arrest and conviction records. Job Type:Full time
06/25/2022
Full time
Manages the day-to-day operations of an assigned property including managing the team members, daily activities, and resources of the property to achieve established budgeted financial and operational goals, and ensures that the operation of the property complies with Company policies and procedures, Fair Housing, Americans with Disabilities Act, Fair Credit Reporting Act, and other laws and regulations governing multi-family housing operations. JOB DESCRIPTION Position will include travel in/around the greater Boston area to assist and support the day to day operations of various communities to meet the needs of the organization. Provides input into the development of budget(s) for the property by analyzing and evaluating financial statements, reviewing current and projected marketing information, and accessing operational reports that establish historic and predict performance patterns. Meets targeted revenues by setting rent rates, ensuring rent and fees are collected and posted in a timely manner, making financial bank deposits, and preparing and reviewing monthly financial status reports. Approves invoices from vendors, contractors, and service providers for payment by reconciling work performed or products purchased, ensuring validity of certificates of insurance, coding charges to appropriate Chart of Account codes, and managing communication between the vendor/contractor, accounting, and the client/owner as needed. Controls expenditures by staying within the constraints of the approved budget and manages the balance and maintenance of the petty cash fund. Oversees the lease enforcement process by approving prospective resident applications, discounts and renewal leases, conducts periodic apartment inspections, follows proper notice requirements, evicts residents, and imposes and collects late fees and other charges as allowable and stated in the terms of the lease. Gathers, analyzes, and interprets current market and economic trends that may impact the property and implements short- and long-range marketing and leasing strategies to achieve the property's occupancy and revenue goals. Promotes resident satisfaction and retention by responding to complaints, questions, and requests in a timely manner, and taking appropriate action to resolve and address service issues. Ensures the property's maintenance team members comply with the Company's standards with respect to responding and completing resident service requests. Conducts regular property inspections and takes appropriate actions to ensure that the physical aspects of the property, grounds, buildings, and amenities meet established standards for safety, cleanliness, and general appearance and appeal. Community Manager Supervises property staff by interviewing, hiring, orienting, and training employees, and manages their performance in accordance with Company policies, values, and business practices. Assists in managing the client/owner relationship by meeting with the owners, conducting property tours, providing updates and information about the property's performance, and responding to owner requests as needed. Depending on the position offered, regular full-time and part-time team members may be eligible to participate in a bonus program in addition to their base salary. Once eligible, team members may participate in the 401k plan. Regular, full-time team members are also offered a range of medical, financial, and/or other benefits from which to choose. Greystar will consider for employment qualified applicants with arrest and conviction records. Job Type:Full time
JOB OVERVIEW: The Counsel will be an experienced patent attorney responsible for biologics projects to join a talented team committed to diversity and inclusion. The attorney will be part of the US team dedicated to all aspects of patent protection for a wide range of programs across Sanofi's business units, including in the area of gene therapy. The attorney will advise on a diverse mix of intellectual property matters, including patent prosecution, worldwide patent portfolio management, overall IP strategy, patentability, and freedom-to-operate analysis. The position reports directly to the Head of Biologics Patents US. The position is located in Cambridge . JOB DUTIES: Prepare, file and prosecute US, EPO and foreign patent applications in biotechnology areas Interact with clients (including Research & Development, Project Management, Business Development, Franchise, Industrial Affairs) in the US and Europe on a daily basis to provide client counselling and proactively solicit invention disclosures Proactively counsel clients about IP strategy related to client's business Provide patentability evaluation of IP related to internal or external projects Initiate, defend and manage post issuance proceedings such as post grant reviews, inter partes reviews, oppositions, litigations Participate in the drafting, reviewing and negotiation of agreements covering intellectual property rights Conduct, direct and analyze patent searches and render opinions on validity, non-infringement and patent avoidance of third-party patents Review proposed research papers and other publications for any impact on existing patent estate Develop and maintain an appropriate network inside Sanofi's Biologics Business Units and Global IP group BASIC QUALIFICATIONS: Graduate degree (MS, PhD) in a biological or biochemistry science would be a plus Registered US Patent Attorney Member of at least one US State Bar for at least 5 years 5-8 years minimum of patent law experience gained in-house and/or in a law firm A motivated self-starting person exhibiting initiative to contribute to the team in more ways than mere handling of assigned projects Experience handling complex biologics IP matters such as gene therapies, nucleic acids, cell therapies, antibodies, peptides, and/or vaccines Able to independently handle preparation and prosecution of patent applications Experience in handling US Inter Partes Reexaminations and EP Oppositions would be a plus Excellent communication skills and agility working with a team of global colleagues Fluent in English, familiarity with French and/or German would be an asset As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
06/25/2022
Full time
JOB OVERVIEW: The Counsel will be an experienced patent attorney responsible for biologics projects to join a talented team committed to diversity and inclusion. The attorney will be part of the US team dedicated to all aspects of patent protection for a wide range of programs across Sanofi's business units, including in the area of gene therapy. The attorney will advise on a diverse mix of intellectual property matters, including patent prosecution, worldwide patent portfolio management, overall IP strategy, patentability, and freedom-to-operate analysis. The position reports directly to the Head of Biologics Patents US. The position is located in Cambridge . JOB DUTIES: Prepare, file and prosecute US, EPO and foreign patent applications in biotechnology areas Interact with clients (including Research & Development, Project Management, Business Development, Franchise, Industrial Affairs) in the US and Europe on a daily basis to provide client counselling and proactively solicit invention disclosures Proactively counsel clients about IP strategy related to client's business Provide patentability evaluation of IP related to internal or external projects Initiate, defend and manage post issuance proceedings such as post grant reviews, inter partes reviews, oppositions, litigations Participate in the drafting, reviewing and negotiation of agreements covering intellectual property rights Conduct, direct and analyze patent searches and render opinions on validity, non-infringement and patent avoidance of third-party patents Review proposed research papers and other publications for any impact on existing patent estate Develop and maintain an appropriate network inside Sanofi's Biologics Business Units and Global IP group BASIC QUALIFICATIONS: Graduate degree (MS, PhD) in a biological or biochemistry science would be a plus Registered US Patent Attorney Member of at least one US State Bar for at least 5 years 5-8 years minimum of patent law experience gained in-house and/or in a law firm A motivated self-starting person exhibiting initiative to contribute to the team in more ways than mere handling of assigned projects Experience handling complex biologics IP matters such as gene therapies, nucleic acids, cell therapies, antibodies, peptides, and/or vaccines Able to independently handle preparation and prosecution of patent applications Experience in handling US Inter Partes Reexaminations and EP Oppositions would be a plus Excellent communication skills and agility working with a team of global colleagues Fluent in English, familiarity with French and/or German would be an asset As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Associate Director / Director, Regulatory Affairs Job Scope & Purpose: Our client, made up of leading experts in cardiovascular medicine, is advancing an exciting pipeline of precision genetic medicines. They are looking for an experienced Regulatory Affairs professional to join their growing team. The position reports to the VP, Regulatory Affairs and will be responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for programs in early development and beyond to support regulatory approvals. Primary Job Responsibilities: Plan, design, and implement clinical, nonclinical, and CMC regulatory strategy including the preparation and submission of regulatory applications. Manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of documents such as IND/IMPD/CTA submissions, meeting requests and briefing documents, and responses to regulatory requests for information while adhering to timelines, company standards, and industry best practices. Act as regulatory contact with regulatory authorities, including participating in meetings with regulatory authorities and managing meeting requests and responses to requests for information from authorities. Represent regulatory affairs on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and best practices. Contribute to the development of risk assessment pertaining to the quality, safety, and efficacy aspects of programs and applications. Primary Job Requirements: Advanced degree (MS, PharmD, Ph.D., MD) in scientific discipline preferred 8+ years' experience in pharmaceutical/biotechnology environment 5+ years in Regulatory Affairs Experience with complex biologics preferred Working knowledge of domestic and international regulations and guidelines regarding phase-appropriate drug development, along with the application of principles, theories, and practices Direct experience interacting with regulatory authorities About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code: ClinOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
06/25/2022
Full time
Associate Director / Director, Regulatory Affairs Job Scope & Purpose: Our client, made up of leading experts in cardiovascular medicine, is advancing an exciting pipeline of precision genetic medicines. They are looking for an experienced Regulatory Affairs professional to join their growing team. The position reports to the VP, Regulatory Affairs and will be responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for programs in early development and beyond to support regulatory approvals. Primary Job Responsibilities: Plan, design, and implement clinical, nonclinical, and CMC regulatory strategy including the preparation and submission of regulatory applications. Manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of documents such as IND/IMPD/CTA submissions, meeting requests and briefing documents, and responses to regulatory requests for information while adhering to timelines, company standards, and industry best practices. Act as regulatory contact with regulatory authorities, including participating in meetings with regulatory authorities and managing meeting requests and responses to requests for information from authorities. Represent regulatory affairs on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and best practices. Contribute to the development of risk assessment pertaining to the quality, safety, and efficacy aspects of programs and applications. Primary Job Requirements: Advanced degree (MS, PharmD, Ph.D., MD) in scientific discipline preferred 8+ years' experience in pharmaceutical/biotechnology environment 5+ years in Regulatory Affairs Experience with complex biologics preferred Working knowledge of domestic and international regulations and guidelines regarding phase-appropriate drug development, along with the application of principles, theories, and practices Direct experience interacting with regulatory authorities About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code: ClinOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Job Description The successful Senior IT Support Specialist will be responsible for utilizing his/her skills to resolve technical problems within the IT Operations Group that cover a multitude of technical disciplines. The successful candidate will display a high level of ownership for IT Operations within the Cambridge site. Sana seeks individuals who are willing to work hard while maintaining a high level of customer service delivery. For our IT team to be successful, we must see no job is too small and no challenge is too big! Responsibilities: Tier 1, 2, and 3 technical support (SW/HW) Receiving/inventorying IT assets & small parts Configuration and deployment of IT assets Imaging IT computer assets Basic repairs of IT assets Managing 3rd party repair agents Preparation of all new hire equipment and supporting the People team at new hire orientation Removal of IT assets from employees who have been offboard Manage the RMA and repair process for all devices under warranty A/V and telephony (Zoom + Zoom Rooms) administration and maintenance Proactive/preventative engagement discovery Basic Qualifications Minimum of 2 years configuring and installing computer hardware and software Deep experience in Microsoft Office 365 applications as well as Windows 10 and the Adobe Suite Demonstrable ability to work and make decisions independently in a fast-paced production environment Excellent written and verbal communication skills High school diploma or equivalent Authorization to work in the U.S. without sponsorship Preferred Qualification A+, Network +, or other IT industry standard certifications Experience troubleshooting integrated and interdependent computer systems Experience maintaining printers, troubleshooting laptops (PCs and Macs) Ability to prioritize work based on business objectives Service Management, Project Management, and Inventory Management skills IT Support Specialists must have the ability to lift up 30lbs as well as being able to be mobile (walking, crawling under desks, climbing a ladder, etc.) with or without reasonable accommodation.
06/25/2022
Full time
Job Description The successful Senior IT Support Specialist will be responsible for utilizing his/her skills to resolve technical problems within the IT Operations Group that cover a multitude of technical disciplines. The successful candidate will display a high level of ownership for IT Operations within the Cambridge site. Sana seeks individuals who are willing to work hard while maintaining a high level of customer service delivery. For our IT team to be successful, we must see no job is too small and no challenge is too big! Responsibilities: Tier 1, 2, and 3 technical support (SW/HW) Receiving/inventorying IT assets & small parts Configuration and deployment of IT assets Imaging IT computer assets Basic repairs of IT assets Managing 3rd party repair agents Preparation of all new hire equipment and supporting the People team at new hire orientation Removal of IT assets from employees who have been offboard Manage the RMA and repair process for all devices under warranty A/V and telephony (Zoom + Zoom Rooms) administration and maintenance Proactive/preventative engagement discovery Basic Qualifications Minimum of 2 years configuring and installing computer hardware and software Deep experience in Microsoft Office 365 applications as well as Windows 10 and the Adobe Suite Demonstrable ability to work and make decisions independently in a fast-paced production environment Excellent written and verbal communication skills High school diploma or equivalent Authorization to work in the U.S. without sponsorship Preferred Qualification A+, Network +, or other IT industry standard certifications Experience troubleshooting integrated and interdependent computer systems Experience maintaining printers, troubleshooting laptops (PCs and Macs) Ability to prioritize work based on business objectives Service Management, Project Management, and Inventory Management skills IT Support Specialists must have the ability to lift up 30lbs as well as being able to be mobile (walking, crawling under desks, climbing a ladder, etc.) with or without reasonable accommodation.
Become a member of the BioNTech Family! As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Director* Clinical Trial Supply Management IMP Logistics At BioNTech, you will set up complex structures to ensure efficient and timely end-to-end supply of our clinical trials with investigational medicinal products in an innovative international environment in compliance with regulatory requirements. Your main responsibilities are: Lead and develop the CTSM Logistics team within Clinical Trial Supply Management Department to support the achievement of company goals of the R&D program portfolio including risk-based decision-making and prioritization Responsible for identifying gaps and driving improvements in CTSM logistics processes with increasing complexity and documentation across all associated functions, all applicable BioNTech entities and across all clinical programs. This includes responsibility for critical decision making processes in coordination with internal and external stakeholders Take leading role in audits and inspections of Clinical trial Supply Management and the management of respective findings and communication of changes to the respective internal and external stakeholders Responsible to integrate continuously new regulatory guidelines and regulations into organizations clinical trial supply and logistics processes and standards to ensure state-of the-art operations and compliance to legal requirements in close collaboration with internal and external functions Ensure that Quality-related processes are kept Degree in supply chain management, pharmacy, chemistry, biotechnology, or related discipline or engineer with profound understanding of clinical supply logistics Many years of experience in Clinical Trial Supply Logistics Management in pharmaceutical or biotech industry setting Very sound knowledge and documented experience in relevant legislation and international GDP guidelines and also in customs regulations and impact of supply chain activities on product quality Demonstrated quality management experience and proven track record of warehousing and distribution of study drugs Profound knowledge and experience in cold chain logistics including impact of product properties and stability on supply chain activities Proven track record of effective capture and integration of latest clinical supply logistics trends and profound understanding of electronic systems supporting logistics processes Business-professional English language skills Company Pension Scheme Childcare Jobticket Company Bike Leave Account Fitness Courses Mobile Office Special Vacation ... and much more.
06/25/2022
Full time
Become a member of the BioNTech Family! As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Director* Clinical Trial Supply Management IMP Logistics At BioNTech, you will set up complex structures to ensure efficient and timely end-to-end supply of our clinical trials with investigational medicinal products in an innovative international environment in compliance with regulatory requirements. Your main responsibilities are: Lead and develop the CTSM Logistics team within Clinical Trial Supply Management Department to support the achievement of company goals of the R&D program portfolio including risk-based decision-making and prioritization Responsible for identifying gaps and driving improvements in CTSM logistics processes with increasing complexity and documentation across all associated functions, all applicable BioNTech entities and across all clinical programs. This includes responsibility for critical decision making processes in coordination with internal and external stakeholders Take leading role in audits and inspections of Clinical trial Supply Management and the management of respective findings and communication of changes to the respective internal and external stakeholders Responsible to integrate continuously new regulatory guidelines and regulations into organizations clinical trial supply and logistics processes and standards to ensure state-of the-art operations and compliance to legal requirements in close collaboration with internal and external functions Ensure that Quality-related processes are kept Degree in supply chain management, pharmacy, chemistry, biotechnology, or related discipline or engineer with profound understanding of clinical supply logistics Many years of experience in Clinical Trial Supply Logistics Management in pharmaceutical or biotech industry setting Very sound knowledge and documented experience in relevant legislation and international GDP guidelines and also in customs regulations and impact of supply chain activities on product quality Demonstrated quality management experience and proven track record of warehousing and distribution of study drugs Profound knowledge and experience in cold chain logistics including impact of product properties and stability on supply chain activities Proven track record of effective capture and integration of latest clinical supply logistics trends and profound understanding of electronic systems supporting logistics processes Business-professional English language skills Company Pension Scheme Childcare Jobticket Company Bike Leave Account Fitness Courses Mobile Office Special Vacation ... and much more.
Scientist II/Sr. Scientist, Chemistry Job Scope & Purpose: Our Watertown based client is currently seeking an exceptional Scientist/Senior Scientist, Oligonucleotide Chemist to add to their team. The candidate will perform synthesis and purification of modified oligonucleotides (ASO, siRNA) for drug discovery programs. The ability to thrive in a fast-paced, goal-driven, and time-sensitive team environment is critical for this role. Please apply if you are ready to join an exceptional next generation gene editing company! Primary Job Requirements: Development of oligonucleotide conjugation with various biomolecules, purification schemes, primary LC-MS analysis Automated synthesis, deprotection, purification, analysis, and packaging of heavily modified oligonucleotides. Critical evaluation and optimization of the processes to improve synthesis yield, purity, and timelines for production of modified oligonucleotides Monitoring, troubleshooting, maintenance, repair equipment or engage repair services of the oligonucleotide synthesizer, HPLC instruments and benchtop equipment to ensure consistent and reliable oligonucleotide production. Maintain a well-documented electronic laboratory notebook Primary Job Responsibilities: Master's or PhD Degree in Chemistry or Chemical/Process Engineering 5+ years' experience in an industry setting, self-motivated with the ability to work in a fast-paced environment Expertise in nucleotide synthesis, modifications, purification, and characterization. Significant experience with solid phase oligonucleotide chemical synthesis, purification, conjugation, and analysis Strong analytical skills, scientific creativity, independent thought, and decision-making ability. Exceptional problem-solving skills for developing creative, innovative solutions, and meeting project objectives. The position requires excellent people skills, a can-do-now attitude, and the ability to embrace our fast-paced team environment. Extensive experience in driving and supporting external teams at CRO's. Proven track record of scientific contributions to projects, including co-inventorship on patents. (Co)-authorship on publications and presentations is required. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code:DiscDevt EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
06/25/2022
Full time
Scientist II/Sr. Scientist, Chemistry Job Scope & Purpose: Our Watertown based client is currently seeking an exceptional Scientist/Senior Scientist, Oligonucleotide Chemist to add to their team. The candidate will perform synthesis and purification of modified oligonucleotides (ASO, siRNA) for drug discovery programs. The ability to thrive in a fast-paced, goal-driven, and time-sensitive team environment is critical for this role. Please apply if you are ready to join an exceptional next generation gene editing company! Primary Job Requirements: Development of oligonucleotide conjugation with various biomolecules, purification schemes, primary LC-MS analysis Automated synthesis, deprotection, purification, analysis, and packaging of heavily modified oligonucleotides. Critical evaluation and optimization of the processes to improve synthesis yield, purity, and timelines for production of modified oligonucleotides Monitoring, troubleshooting, maintenance, repair equipment or engage repair services of the oligonucleotide synthesizer, HPLC instruments and benchtop equipment to ensure consistent and reliable oligonucleotide production. Maintain a well-documented electronic laboratory notebook Primary Job Responsibilities: Master's or PhD Degree in Chemistry or Chemical/Process Engineering 5+ years' experience in an industry setting, self-motivated with the ability to work in a fast-paced environment Expertise in nucleotide synthesis, modifications, purification, and characterization. Significant experience with solid phase oligonucleotide chemical synthesis, purification, conjugation, and analysis Strong analytical skills, scientific creativity, independent thought, and decision-making ability. Exceptional problem-solving skills for developing creative, innovative solutions, and meeting project objectives. The position requires excellent people skills, a can-do-now attitude, and the ability to embrace our fast-paced team environment. Extensive experience in driving and supporting external teams at CRO's. Proven track record of scientific contributions to projects, including co-inventorship on patents. (Co)-authorship on publications and presentations is required. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code:DiscDevt EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Become a member of the BioNTech Family! As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Manager* Clinical Trial Supply Vendors BioNTech is looking to add a new Vendor Manager to our Clinical Trial Supply Management team. This is a position to strengthen the Vendor Management team and ensure we are thoughtfully building practice and processes to successfully manage relationships with vendors. The Clinical Trial Supply Management is responsible for ensuring the supply of study medication to clinical trials (Phase I-III) worldwide on an as-needed and on-time basis across BioNTech. This includes medical investigational drugs, comparator and combination medications, placebo, and related medical consumables. Our primary objectives are to ensure the availability as well as the quality of study medication, thus always ensuring patient safety and treatment. You will play a key part in collaborating and working closely with different stakeholders like Legal, QA, Procurement, Finance but also international R&D teams across BioNTech. This requires being hands on with contract reviews, being able to build strong partnerships with vendors, with the ability to multitask and guide internal stakeholders on process best practices. You will also take over vendor oversight and improve the customer experience with our vendor counterparts, to map out our visions and strategies for success. You will establish and monitor continuous improvement initiatives and performance measures. Your main responsibilities in detail: Vendor Management end to end process. Identification, selection, awarding, active management and monitoring of external suppliers/vendors in the field of clinical trial supply; building and sustaining positive relationships with vendors Managing day-to-day business and supporting the CTSM team in vendor related tasks. Effective stakeholder management and representation, both in cross-functional internal and external international matrix team environment. Vendor oversight, incl. performance tracking, support of project teams in the resolution of service provider performance matters. Liaise with Quality Assurance for qualifications, support in preparation of e.g. quality assurance agreements, liaise with Legal for contract negotiations and also with Procurement in P2P Degree in a commercial or business discipline or supply chain management. Understanding of natural scientific / technical processes would be prefered Profound knowledge in pharmaceutical procurement with focus on Clinical Outsourcing Excellent negotiation skills, good communication and cooperation as well as experience in national and international stakeholder management Well-structured working style in a versatile environment Ability to engage and lead in a matrix environment Knowledge and experience in relevant legislation and international GxP guidelines. Fluency in English, written and spoken Company Pension Scheme Childcare Jobticket Company Bike Leave Account Fitness Courses Mobile Office Special Vacation ... and much more.
06/25/2022
Full time
Become a member of the BioNTech Family! As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Manager* Clinical Trial Supply Vendors BioNTech is looking to add a new Vendor Manager to our Clinical Trial Supply Management team. This is a position to strengthen the Vendor Management team and ensure we are thoughtfully building practice and processes to successfully manage relationships with vendors. The Clinical Trial Supply Management is responsible for ensuring the supply of study medication to clinical trials (Phase I-III) worldwide on an as-needed and on-time basis across BioNTech. This includes medical investigational drugs, comparator and combination medications, placebo, and related medical consumables. Our primary objectives are to ensure the availability as well as the quality of study medication, thus always ensuring patient safety and treatment. You will play a key part in collaborating and working closely with different stakeholders like Legal, QA, Procurement, Finance but also international R&D teams across BioNTech. This requires being hands on with contract reviews, being able to build strong partnerships with vendors, with the ability to multitask and guide internal stakeholders on process best practices. You will also take over vendor oversight and improve the customer experience with our vendor counterparts, to map out our visions and strategies for success. You will establish and monitor continuous improvement initiatives and performance measures. Your main responsibilities in detail: Vendor Management end to end process. Identification, selection, awarding, active management and monitoring of external suppliers/vendors in the field of clinical trial supply; building and sustaining positive relationships with vendors Managing day-to-day business and supporting the CTSM team in vendor related tasks. Effective stakeholder management and representation, both in cross-functional internal and external international matrix team environment. Vendor oversight, incl. performance tracking, support of project teams in the resolution of service provider performance matters. Liaise with Quality Assurance for qualifications, support in preparation of e.g. quality assurance agreements, liaise with Legal for contract negotiations and also with Procurement in P2P Degree in a commercial or business discipline or supply chain management. Understanding of natural scientific / technical processes would be prefered Profound knowledge in pharmaceutical procurement with focus on Clinical Outsourcing Excellent negotiation skills, good communication and cooperation as well as experience in national and international stakeholder management Well-structured working style in a versatile environment Ability to engage and lead in a matrix environment Knowledge and experience in relevant legislation and international GxP guidelines. Fluency in English, written and spoken Company Pension Scheme Childcare Jobticket Company Bike Leave Account Fitness Courses Mobile Office Special Vacation ... and much more.
Job Description About This Role Our Business Development team supports the overall strategy by targeting, evaluating, and executing external growth opportunities for Biogen via licensing, collaborations, equity investments and/or M&A transactions. This role supports the assessment of growth opportunities, partners with business teams, leads due diligence, and negotiates transactions. This is a high impact role working across many large functions. This role collaborates closely with External Innovation, Solutions, and Science teams across Pharma and Digital business units to evaluate external growth opportunities and execute a variety of transactions including but not limited to licensing and M&A. The individual will report to Senior Director, Business Development. What You'll Do • Consider broad Biogen corporate priorities and participate in strategy planning for financial investment trade-off decisions required for corporate growth. • Participate in one or more cross functional committees responsible for the initial triaging of externally generated licensing, collaboration, equity investments and/or M&A opportunities opportunities. • Lead negotiations in business transactions. • Work effectively with legal, finance and scientific teams and make business development proposals to senior management. • As a thought leader in the pharma, digital health and life sciences areas, stay abreast of market trends and build relationships with the startup and investment community
06/25/2022
Full time
Job Description About This Role Our Business Development team supports the overall strategy by targeting, evaluating, and executing external growth opportunities for Biogen via licensing, collaborations, equity investments and/or M&A transactions. This role supports the assessment of growth opportunities, partners with business teams, leads due diligence, and negotiates transactions. This is a high impact role working across many large functions. This role collaborates closely with External Innovation, Solutions, and Science teams across Pharma and Digital business units to evaluate external growth opportunities and execute a variety of transactions including but not limited to licensing and M&A. The individual will report to Senior Director, Business Development. What You'll Do • Consider broad Biogen corporate priorities and participate in strategy planning for financial investment trade-off decisions required for corporate growth. • Participate in one or more cross functional committees responsible for the initial triaging of externally generated licensing, collaboration, equity investments and/or M&A opportunities opportunities. • Lead negotiations in business transactions. • Work effectively with legal, finance and scientific teams and make business development proposals to senior management. • As a thought leader in the pharma, digital health and life sciences areas, stay abreast of market trends and build relationships with the startup and investment community