Senior QA Operations Specialist, Gene Therapy
Ultragenyx
Ultragenyx Gene Therapy in Bedford, MA is seeking a Senior Specialist, Quality Assurance Operations to oversee QA activities for drug substance manufacturing at a new gene therapy facility. You will review batch records, manage deviations, and support manufacturing approvals across DS and potentially DP. The role partners with Manufacturing, Engineering, Validation, QC, Quality Systems, and MSAT to ensure GMP compliance and timely investigations. On-site, four 10-hour days with a 7:00–8:30 start. #J-18808-Ljbffr Ultragenyx
- Ultragenyx Pharmaceutical in Bedford, MA seeks a Quality Assurance Drug Substance (DS) Specialist to oversee QA activities for a gene therapy manufacturing site. You will review batch records, perform deviations management, and collaborate across Manufacturing, Engineering...Senior
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...Job Description The field of gene therapy is growing rapidly and Genezen is... ...biologics/gene therapy manufacturing operations, the Quality Assurance Specialist II engages in collaborative day to... ...batch disposition activities. QA support of drug product aseptic fill...SuggestedLive inVisa sponsorshipMonday to FridayAfternoon shift- Sana Biotechnology, Inc. is seeking a Senior Director to lead the company’s IP strategy in cell and gene therapy. You will draft and prosecute patents, manage global portfolios, and guide landscape analyses. Collaboration with R&D and external counsel is essential to align...Senior
- Dyno Therapeutics is seeking a Senior Research Associate to advance animal studies and identify muscle AAV-based capsids. You will... ...optimize workflows, troubleshoot issues, and ensure high-quality data to inform gene therapy programs. #J-18808-Ljbffr Dyno TherapeuticsSenior
$110k - $120k
...and potential of CRISPR gene editing to transform... ...respected, where you can operate at the forefront of... ...role is part of a small QA team with... ...best-in-class, one-time therapy designed to significantly... ...Your Impact: As the Senior QA Specialist, you will: Maintain...SeniorFlexible hours- Anika in Bedford, MA is seeking a Senior Quality Assurance Specialist to provide QA oversight across CMC development, manufacturing, and supply chain. You... ...The role demands collaboration with CMC, Technical Operations, and external partners to drive inspection-ready programs...Senior
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...The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs... ...part of that team. Job Summary The QC Senior/Principal Scientist for Analytical Method... ...appropriate readiness. Support cGMP operations, including generation of documentation...SeniorImmediate startVisa sponsorship- Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility. You'll gown into ISO 7 clean rooms and support release activities...RelocationWeekend work
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- ...commercial strategy and opportunity assessments for precision genetic therapies. You will coordinate with Research, Clinical Development,... ...teams, shaping program plans and presenting findings to senior leadership. Ideal candidates have 10+ years in biotech/pharma strategy...Senior
- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical Development... ...activities across drug substance and drug product operations, including external manufacturing partners and CDMOs.•...SeniorFull timeContract workImmediate start
$175k - $195k
...Senior Manager, Marketing Operations Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and...SeniorContract workWork at officeFlexible hours$220k - $240k
...safe manufacture of new drug therapies. When you join our family, you... ...professional to serve as a Senior Principal Scientific Advisor... ...modalities, including cell and gene therapies, oligonucleotides,... ...Account Management, Marketing, and Operations by ensuring that clients’...SeniorContract workLocal areaRemote workWorldwideFlexible hours- ...Quality Assurance Specialist Integrated Resources, Inc is a premier... ...Research, Rehabilitation Therapy and Nursing. Job Description... ...Professional will work in the Internal QA team of Human Genetic... ...Commercial QA Compliance and Operations. Deviation Review and Final...
- ...are looking to recruit a Senior Scientist, Analytical... ...provide scientific and operational leadership for analytical... ...deliver life-changing therapies to patients. Your... ...based Assays (e.g. TCID50, Gene expression, flow cytometry... ...(e.g. QC, Internal QA, External QA) to ensure...SeniorContract work
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...development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business... ...Innovation - TRUE Innovation!Position Summary:The Senior Manager, Clinical Laboratory Operations will be responsible for leading the operational execution...Senior$28.85 - $34 per hour
...Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care,... ...ISO 7 cleanroom. Support day to day operations, including batch record review, label... ...final product. Support projects as a QA resource. Identifies deficiencies and...Hourly payFor contractorsWork at officeMonday to FridayWeekend work$110k - $120k
Editas Medicine in Cambridge, MA seeks a QA professional to oversee GMP operations, review batch records, and disposition lots. You will collaborate with CDMOs/CTOs and author GMP documentation to support manufacturing and quality events. The role requires a BS in a scientific...Senior- ...AP Operations Specialist A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most... ...Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Working knowledge of...Work experience placement
$235k - $330k
...provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016,... ...valued, seen, and heard.How you’ll make an impact:The Senior Director, Clinical Operations is a leadership role responsible for overseeing and managing...SeniorLocal area$96.17k - $116.24k
Senior Research Associate As a hands-on molecular biology expert, you will play a key... ...quality data that shapes the future of gene therapy. Job Type: Full Time Location: Watertown... .... Whether in science, engineering, operations, or business, each AAViator contributes...SeniorFull timeFlexible hoursShift work$140k - $165k
...and New York City with 250+ employees world-wide.As the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor... ...to Iterative Health's mission of bringing innovative therapies to patients faster.As Iterative Health continues to...SeniorTemporary workWork at office2 days per week- ...Senior Analyst A Few Words About Us - Integrated Resources, Inc... ...Research, Rehabilitation Therapy and Nursing. Job Description... ...timelines with supervisor. · Operates under compliance requirements... ...Preferred. · Senior specialist who can focus on Non-laboratory...SeniorContract work
- EMD Serono in Billerica, MA seeks a Senior Clinical Research Scientist to serve as SME... ...contributing scientific, clinical, and operational input across early and late-stage programs... ...prepare publications while advancing innovative therapies. #J-18808-Ljbffr Biopharma CareersSenior
$130k - $190k
...assembled a platform with integrated gene editing, delivery and... ...development portfolio.Reporting to the Senior Director of Data Management,... ...work closely with Clinical Operations, Biostatistics, Statistical... ...helping advance innovative therapies in a fast-paced biotechnology...SeniorFull timeInterim role- ...genuine.I joined Kymera because I was interested in being a part of an innovative team that fearlessly treads forward in the degrader therapy space to develop medicines that will directly impact patient's lives.Seth AnnanAssociate Director, CMC Project ManagerWe recognize...SeniorSummer workWork at office
$115k - $140k
...Job Description Job Description The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our... ...validation practices that support our Quality Management System and operational excellence. JOB RESPONSIBILITIES Lead risk-based...SeniorContract workLive inWork at officeVisa sponsorship$88k - $113k
...uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing... ...purpose; whether you're in research, operations, access, or support, your contributions... .... Part of the Global IT team, the Senior IT Support Engineer is the senior on‑site...SeniorMinimum wageWork experience placementWork at officeLocal areaRemote work- ...Corporation, a leader in regenerative medicine, is seeking a Manufacturing Compliance Specialist to ensure cell therapy operations meet cGMP and quality systems. You will partner with Manufacturing, QA, QC, Engineering, Development and Supply Chain to investigate events,...SeniorShift work
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