Senior Scientist, Cell Therapy CMC & Regulatory Lead
Astellas Pharma
Astellas Pharma in Westborough, MA is seeking a Senior Scientist to lead drug product readiness activities for cell therapy programs, developing formulations, manufacturing processes, and control strategies to support development, regulatory submissions, and manufacturing readiness. You will plan and execute development studies, enable commercialization through evidence and technical justifications, and provide technical leadership and mentorship to junior scientists and project teams. #J-18808-Ljbffr Astellas Pharma
$199.22k - $284.6k
...provide transformative therapies in disease areas... ...is accountable for CMC activities... ...or more strategic Cell Therapy assets from... ...transition. The CMC Lead serves as the single... ...development, manufacturing, regulatory, quality, supply... ...governance bodies, senior leaders, and alliance...SeniorRegulatoryWork at officeWork from homeWorldwide$119k - $170k
...provide transformative therapies in disease areas... ....Purpose & Scope Lead and manage drug... ...readiness activities for cell therapy programs... ...development, regulatory submissions, and manufacturing... ...activities and CMC strategies as part... ...to junior scientists, research associates...SeniorRegulatoryWorldwide$94.57k - $135.1k
Job DescriptionScientist I, Cell Therapy Editing Strategy and AnalyticsAbout Astellas Astellas... ...Purpose & Scope The primary purpose of Scientist I, Cell Therapy Editing Strategy and... ...reports, Standard Operating Procedures (SOPs)regulatory filings and tech transferEnsure smooth...RegulatoryWorldwide$144.06k - $205.8k
...provide transformative therapies in disease areas... ...role in the Regulatory Affairs department... ...Manufacturing and Controls (CMC) aspects of... ...as a CMC regulatory lead for highly complex... ...Qualifications Gene and Cell Therapy Experience... ...Frequent interaction with senior leadership and...RegulatoryWork at officeLocal areaRemote workWork from homeWorldwide- RoslinCT US in Hopkinton, MA seeks a Senior Compliance Specialist to lead investigations, deviations, CAPAs, change controls, and continuous improvement within GMP cell therapy operations. You will partner with Manufacturing, Quality Assurance, Validation, MS&T, and Supply...Senior
- Astellas in Westborough, MA is seeking a senior Regulatory CMC leader to develop and drive global CMC regulatory strategy and submissions. You will collaborate with RA, QA, and technical teams across regions to ensure compliant, timely registrations for NMEs and changes...RegulatoryRemote job
- ...Description Job Description WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization... ...expectations, Good Documentation Practices, and regulatory expectations for sample handling, traceability, chain of...RegulatoryContract workFlexible hoursAfternoon shift
$145.46k - $207.8k
...patients. We provide transformative therapies in disease areas that include oncology... ...this role as an Integrative Science Lead within Cell and Gene Therapy Research, you will serve... ....Translating program, asset team, regulatory, CMC, clinical, and organizational needs into...RegulatoryWorldwide$145.46k - $207.8k
...DescriptionPrincipal Scientist, Ophthalmology ResearchAbout... ...transformative therapies in disease areas that... ...requiring the scientist to lead from the bench, while... ...milestones and regulatory submissions to health... ...biologics, gene therapies, cell therapies, or RNA-based...RegulatoryContract workWorldwide$105.28k - $150.4k
...provide transformative therapies in disease areas that... ...impact.Purpose & Scope Senior Process Engineer,... ...Chain, Automation/IT, Regulatory/CMC, and external partners... ...protocols for human stem-cell-based cell therapy processes... ...or technical reports.Lead or significantly...SeniorRegulatoryWorldwide- RoslinCT is seeking a Senior QA Specialist - Plant Operations to provide QA support for manufacturing plant operations, including batch... ...8 years of QA experience in pharma/biotech with internal manufacturing; cell therapy experience is preferred. #J-18808-Ljbffr Socket.devSenior
- Astellas Pharma is seeking a Scientist I, Cell Therapy Editing Strategy and Analytics, for its Westborough, MA location. This laboratory-based role focuses on developing editing strategies for cell therapies and coordinating cross-functional programs to ensure timely delivery...
- ...WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization... .... ACCELERATING YOUR FUTURE The Senior Compliance Specialist is responsible... ...activities to ensure compliance with regulatory requirements, company procedures, and...SeniorRegulatoryContract workWork at officeFlexible hours
$122.25k - $176.58k
Job Title: Principal Scientist - CMC StatisticianLocation: Framingham, MAAbout the jobAs part of the development of Sanofi’s pharmaceutical... ...compliance with internal policies, external guidelines, and regulatory standardsServe as the CMC statistics contact and local...RegulatoryFull timeLocal area$94.57k - $135.1k
Job DescriptionQC Scientist I, MicrobiologyAbout Astellas Astellas is a global life sciences... ...patients. We provide transformative therapies in disease areas that include oncology,... ...QC environment, knowledge of cGMPs and regulatory requirements pertaining to...RegulatoryContract workWorldwideMonday to FridayDay shift- ...new scientific proposals and lead those efforts. Investigate, identify... ...techniques. Act as a lead scientist in his/her area of expertise... ...relevant scientific and regulatory advances and integrate this knowledge... ...hybrid models for CHO based cell culture and downstream...SeniorRegulatoryFull timeLocal area
- ...Job Description WHO WE ARE We at RoslinCT are a world-leading cell and gene therapy contract development and manufacturing organization... ...biopharmaceutical product development, manufacturing, and regulatory requirements. · Self-motivated, with excellent organization...SeniorRegulatoryContract workFlexible hours
- ...We are seeking an enthusiastic and creative hands-on senior scientist to join the Cell Culture Process Development group within PDS&T Biologics... ...technical transfer, and manufacturing support activities. Lead and execute scientific research and development initiatives...SeniorFull timeTemporary workLocal area
$112.5k - $146k
...cancer treatment with therapies designed to activate a... ...future. Job Summary: The Scientist I/II, QC Analytical... ...Assist with audits and regulatory inspections, as needed... ...maximize immunogenic cell death and the induction... ...treatment modalities, leading to the versatility to...RegulatoryContract workLocal areaFlexible hours- ...Job Description Job Description WHO WE ARE We at RoslinCT, are a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are...Contract workFlexible hours
- Senior Associate Scientist, Bioprocess Analytics Location: Framingham, MA About The Job Sanofi is committed to... ...striving to bring next generation, transformative therapies to patients. Our BioAnalytics US team, as part of Global CMC Development organization, plays a critical...SeniorFlexible hours
- CyberThink Pvt. Ltd. is looking for a dedicated Scientist to contribute to the development of gene therapies for rare genetic diseases. The ideal candidate should... ...years of experience in related fields, with skills in cell culture and assays, as well as strong communication...
$135k - $145k
...vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able... ...everything possible.The Senior Manager, Digital Content Strategy... ...compliance with legal and regulatory standards across all... ...drive traffic, and support lead generation.Collaborate with...SeniorRegulatoryFull time$110k - $140k
...vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able... ...everything possible. The Senior Supplier Quality Engineer is... ...supplier audit planning. Lead remediation activities due... ...08-26Profession: Quality & Regulatory AffairsEmployment type: Full...SeniorRegulatoryHourly payFull time- AbbVie is seeking a Principal Research Scientist I to join the Biotherapeutic and Genetic Medicine (BGM) siRNA group in Worcester, MA. The role focuses on establishing siRNA synthesis, purification, and analytical capabilities to generate high-quality siRNA materials for...Senior
- University of Massachusetts Medical School seeks a Senior Research Scientist to conduct complex laboratory research under the PI, performing recombinant... ...staff, managing supplies, and ensuring safety and regulatory compliance in a wet lab environment. The candidate will...SeniorRegulatory
- University of Massachusetts Medical School in Worcester seeks a Senior Research Scientist under the direction of the Principal Investigator to design and execute complex experiments, organize data, and contribute to publications and grant applications. You will train junior...Senior
- ...CRISPR Therapeutics is a leading biopharmaceutical... ...world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion... ...California.Position SummaryThe Senior Specialist, Site Supply... ...growing knowledge of regulatory compliance (FDA, GMP,...SeniorRegulatoryFull timeWork at office
- Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for product development, sustaining engineering projects, and integration activities within our Urology portfolio. You will partner with cross-functional teams to ensure regulatory...SeniorRegulatory
- Replimune seeks a Quality Systems specialist to administer and optimize eQMS platforms, ensuring regulatory compliance and inspection readiness. The role supports governance, workflows, and cross-functional collaboration across sites. The ideal candidate has deep GxP experience...SeniorRegulatory
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