Senior QA & Validation Lead - GMP Cell & Gene Therapy
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Verista is seeking a Senior Quality Engineer in Boston, MA to provide QA oversight for GMP manufacturing operations and support validation, qualification, and compliance activities across R&D and commercial programs. You will partner with Manufacturing, Validation, Engineering, Facilities and Laboratory Operations to ensure regulatory compliance and risk-based decision-making throughout the product lifecycle. #J-18808-Ljbffr Socket
$148k - $222k
...and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role is responsible... ...not limited to, the following:-Process Lead for Annual Product Quality Review (APQR... ...and deep expertise in global GMP regulations, guidances, and Quality Management...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per week- ...Director in Boston to oversee Quality Assurance Manufacturing Technical Services. This role includes managing quality operations for Cell & Gene Programs and ensuring compliance with regulatory standards. The candidate should hold a Bachelor’s in biotech/life sciences,...Suggested
- ...defining and executing the Cell & Genetic Therapies (CGT) Quality vision, operating... ....Represent C&G Quality to lead/participate in complex projects... ...governance for PPQ, process validation, comparability, and... ...across GXP life cycle in Cell & Gene therapy and/or Biologics.Broad...SuggestedFull timeSummer workFlexible hours
- Mariana Oncology is seeking a Senior QA Specialist for Radioligand GMP Manufacturing Operations. The role focuses on ensuring compliance with quality standards... ...of radiopharmaceuticals, supporting QA activities, and leading investigations. The ideal candidate holds relevant...Senior
$318k - $337.5k
## Senior Vice President, Cell Therapy Product Supply OperationsApplyremote type: OnSitelocations... ...of Bayer AG, is a leading engineered cell therapy company... ...stem cell technology and gene editing to deliver authentic... ...with Quality to ensure GMP compliance and inspection readiness...SeniorContract workWorldwide$200k - $260k
...to build a world leading oncology company... ...the next wave of therapies for cancer patients... ...a Director/Senior Director, GMP Quality Assurance... ...oversight across master cell bank, working... ...management, process validation/PPQ, and... ...demand. Lead QA input into CDMO selection...SeniorContract workTemporary workFlexible hours- Aurion Biotech in Cambridge, MA is seeking a Senior Scientist, Analytical Development to lead analytical method development for cell therapy products. You will work with cross-... ...in Flow Cytometry, qPCR/dPCR, ELISA, and GMP documentation, with collaboration across Research...Senior
- Meet Life Sciences is seeking a Senior Manufacturing Associate to support GMP manufacturing with a focus on cell culture processes, operations excellence, and compliance. This hands‑on role requires independence on the third shift, involvement in quality activities, and...SeniorShift work
- Vertex Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee deviations, investigations and CAPAs, ensuring inspection readiness and regulatory compliance across...SeniorShift work
$160k - $190k
...potential of engineered cells as medicines, who want to... ...the status quo, and who lead with the desire to work... ...islet differentiation. As a Senior Scientist, you will... ...-5 years of direct cell therapy industry experienceSignificantly... ...platformsPassion for GMP transition, automation,...SeniorTemporary workImmediate start$190k - $240k
...Territory US Reporting to: Senior Director, Medical... ...Kirin company, is a global gene therapy leader focused on... ...modified hematopoietic stem cells (HSCs). Orchard has its... ...as a team mentor, and lead national level initiatives... ...of assigned territory· Valid US Driver’s License and...SeniorFull timeLocal areaRemote work- ...highly motivated and innovative Senior Associate Scientist to join... ...discovery research team at Regeneron Cell Medicines. You will be... ...development of CAR/TCR T cell therapies in solid tumor indications Characterizing... ...assays is required. Gene delivery into T cells or tumor...Senior
$82.01k - $113.3k
...Overview Prime Medicine is a leading biotechnology company... ...next generation of gene editing therapies to patients. The... ...different tissues, organs and cell types. Prime Medicine... ...a highly motivated Senior Laboratory Operations... ..., vivarium, and GMP operations. This individual...Senior$80.3k - $131.1k
...highly motivated and innovative Senior Associate Scientist to join... ...discovery research team at Regeneron Cell Medicines. You will be... ...development of CAR/TCR T cell therapies in solid tumor indications. Characterize... ...assays. Experience with gene delivery into T cells or tumor...Senior$250k - $300k
...potential of engineered cells as medicines, who... ...status quo, and who lead with the desire to... ...commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development,... ...and validation activities, leveraging... ...material selection for GMP manufacturing. In depth...Senior- ...Cambridge, MA is seeking a highly motivated Senior Associate Scientist to perform... ...analyzing genetically engineered human primary T cells. This role involves contributing to preclinical... ...and development of CAR/TCR T cell therapies while maintaining excellent attention to...Senior
- Sana Biotechnology, Inc. is hiring a Senior Director for Late-Stage Cell Therapy Process Development in Cambridge, MA. You'll oversee the development... ...compliance with regulatory standards, and leading process validation activities. Ideal candidates should have a Ph.D....Senior
- Noara Therapeutics, Cambridge, MA, is seeking a Senior Scientist or Scientist with deep expertise in cell biology, immunology, and assay development to lead the design and execution of cell-based and immunology assays that drive therapeutic discovery. This laboratory-based...Senior
$150k - $165k
CRISPR Therapeutics Inc. in Boston is seeking a Senior Manager, Alliance Management, to oversee strategic collaborations and initiate new... ...environment, demonstrating an urgency for developing essential gene-based medicines. The position offers a competitive salary...Senior- A biopharmaceutical company is looking for a Senior Scientist, Process Development to join their Watertown, MA team. This role involves executing cell culture experiments and downstream processing, along with data analysis and project contributions. The ideal candidate...Senior
- Zachary Piper Solutions seeks a Sr Research Associate to support a biotech company focused on next-generation immune cell therapies at our Cambridge, MA site. The role executes cell culture, differentiation, molecular biology, and process development to advance a stem...Senior
- Aurion Biotech, Inc. is seeking a Senior Scientist for Analytical Development in Cambridge, MA, to execute assays for cell therapy products. The role encompasses conducting independent experiments, collaborating with various teams, and authoring technical documents for...Senior
$154.4k - $242.55k
...DescriptionJoin Takeda as a Senior/Principal Scientist, Cell Based-Potency Assay... ...independently and leading function teams or... ..., qualification, validation, transfer, and lifecycle... ...development, GMP release and stability... ...biologics, vaccines, cell therapy, gene therapy, or related...SeniorMinimum wageContract workTemporary workLocal area- ...developing next‑generation RNA‑LNP‑based cell therapies for the treatment of autoimmune diseases... ...seeking a highly motivated scientist to lead the development and execution of cell‑... ...Position Summary We are seeking an experienced Senior Scientist or Scientist with deep...Senior
$145k - $161k
...Overview:Prime Medicine is a leading biotechnology company... ...next generation of gene editing therapies to patients. The... ...different tissues, organs and cell types. Prime Medicine... ....Position SummaryThe Senior Scientist / Senior... ...from bench through GLP/GMP scale, with emphasis on...SeniorFull timeContract workTemporary work- A major IT staffing company is seeking a Quality Compliance Investigator to manage and lead investigations into GMP operations. The candidate will support internal and external audits, ensure compliance with CGMP standards, and track corrective actions effectively. With...Senior
- Lead the development, optimization, and qualification of cell-based potency assays that evaluate the biological activity of cell therapy products. Design and execute functional... ...are suitable for GMP environments. Analyze... ...SOPs, protocols, validation reports, method transfer...SeniorContract work
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction... ...science into real options for patients? This role leads high-impact programs across cancer, immune-mediated...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$80k - $110k
...is to turn scientific breakthroughs into transformative therapies and get them quickly, safely and efficiently to the patients... ..., creative and collaborative Research Associate/Senior Research Associate in Cell Biology and Immunology to join our growing team. You will...Senior$120k - $160k
...The field of gene therapy is growing rapidly and Genezen... ..., produce GMP viral vectors, and provide cell transduction for gene... ...of the process that leads to new cures. Working... ...Job Summary The QC Senior/Principal Scientist... ...Analytical Method Validation is a key role within...SeniorImmediate startVisa sponsorship
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