Senior Cell Therapy Compliance Lead, cGMP/QA
Scorpion Therapeutics
Scorpion Therapeutics in Burlington, MA, is seeking a Manufacturing Compliance Specialist to ensure compliance in cell therapy operations. This role involves leading deviation investigations, managing quality systems, and technical support for manufacturing processes. The ideal candidate will have a BA/BS in a scientific field, 3–6 years in biopharmaceutical manufacturing, and a solid understanding of cGMP regulations. Working conditions require onsite presence Monday to Friday, with occasional weekend work. #J-18808-Ljbffr Scorpion Therapeutics
- ...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
$135k - $155k
...Burlington, MA is looking for a Sr. Manufacturing Compliance Specialist to ensure compliance with Good Manufacturing Practices in cell therapy operations. This role requires expertise in... ...Management Systems and the ability to lead cross-functional projects. The ideal...SeniorFull time- ...seeking a Manufacturing Associate to execute process steps in a cell therapy production clean room for MACI, Epicel, and related programs.... ...every operation in electronic batch records to ensure compliance and traceability. Training lasts 3-5 months onsite in Burlington...SeniorShift work
$32 - $39 per hour
...we are pioneers in advanced cell therapies for sports medicine and severe... ...Summary: The Manufacturing Team Lead is responsible for leadership... ...demands consistent with cGMP and company corporate quality... ...activities to ensure compliance to all Vericel SOP and cGMP requirements...SuggestedHourly payFor contractorsEarly shift- ...Materials Specialist to stock and manage materials for cell therapy production. This onsite role in Burlington, MA supports manufacturing in compliance with SOPs and cGMPs. The position requires 1-2 years in a cGMP environment and strong MS Office skills. You will handle...Suggested
- Anika is seeking a Senior QC Incoming Inspector to support inspection, approval, and release of raw materials and... ...disposition, documentation review, and quality system compliance. The role requires 4+ years in a cGMP environment, strong attention to detail, excellent...Senior
$21 - $25 per hour
...Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care... ...0 - 1 years of experience working in a cGMP environment in the biotechnology or pharmaceutical... ...? Cutting-Edge Science: Work with a leading regenerative medicine product that is...SeniorHourly payFor contractorsWork at officeMonday to FridayShift workWeekend work1 day per week$135k - $155k
...we are pioneers in advanced cell therapies for sports medicine and severe... ...burn care). The Manufacturing Compliance Specialist serves as the... ...Good Manufacturing Practices (cGMP), regulatory requirements, and... ...QMS) expertise, the ability to lead cross‑functional initiatives...SeniorHourly payFor contractorsMonday to FridayShift workWeekend workAfternoon shift$200k - $260k
...to build a world leading oncology company bringing... ...the next wave of therapies for cancer... ...seeking a Director/Senior Director, GMP Quality... ...across master cell bank, working cell... ...supply demand. Lead QA input into CDMO... ...DMS, LMS), ensuring compliance with Part 11 /...SeniorContract workTemporary workFlexible hours- Anika in Bedford, MA is seeking a Shift Lead to oversee day-to-day manufacturing operations in a cGMP environment. You will lead the team in executing production activities, ensuring compliance with safety and quality standards. The ideal candidate has at least 6 years...Shift work
- ...Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. The Quality Assurance Professional will work in the Internal QA team of company's Human Genetic Therapies... ...of company. Support of Commercial QA Compliance: Deviation Review and Trending, CAPA...Senior
- ...commercialization of innovative therapies for diseases and conditions... ....Position Summary:The Senior Associate, QA will work in collaboration... ...(QC) activities to ensure compliance with applicable regulatory... ...oversight and phase-appropriate cGMP guidance throughout the...SeniorLocal area
$195k - $330k
...Kymera is focused on building an industry-leading pipeline of oral small molecule degraders... ...of convenient, highly effective therapies for patients with these conditions. Founded... ...multiple assay technology platforms (e.g., cell-based assays, molecular-based assays, single...Senior- Phoenix Tailings is seeking a Grant Program Manager to own post-award compliance, reporting, and agency relationships. You will be the primary liaison with DOE, ARPA-E, and other agencies, ensuring awards stay in good standing and requirements are met on time. You will...Senior
$110k - $120k
...is to advance our lead in vivo development... ...by ensuring compliance with FDA, cGMP, and international... ...is part of a small QA team with opportunities... ...-class, one-time therapy designed to significantly... ...Impact: As the Senior QA Specialist, you... ..., protein, RNA, cell/gene therapy, and/...SeniorFlexible hours- Lantheus Medical Imaging, Inc. in Bedford, MA seeks a seasoned Document Control Senior Specialist to oversee the corporate document control program within Quality Systems and Compliance. You will manage lifecycle controls in eDMS TrackWise Digital, ensuring documents are...Senior3 days per week
$120k - $160k
...The field of gene therapy is growing rapidly... ...vectors, and provide cell transduction for gene... ...the process that leads to new cures. Working... ...Job Summary The QC Senior/Principal Scientist... ...products in compliance with company policies... ...methods associated with cGMP production. SME for...SeniorImmediate startVisa sponsorship$24 - $26 per hour
...Corporation is seeking a Manufacturing Associate to execute processes in Burlington, MA, producing cell therapy products. Responsibilities include compliance with cGMP regulations, conducting manufacturing procedures, and maintaining records. The ideal candidate will...Hourly pay- ..., MA is seeking a Manufacturing Associate responsible for executing process steps to manufacture commercial cell therapy products, ensuring compliance with cGMP and SOPs in a clean room environment. The role emphasizes aseptic manipulations, documentation in Electronic...Hourly pay
$186.23k - $279.35k
...Regulatory TA leadership team and Lead RPMs, ensuring cost effective... ...adheres to and remains in compliance with AZ standards, processes,... ...across collaborations. As a senior member of the RAM community,... ...transform pioneering science into therapies that reach patients faster—by...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week$160k - $180k
...experienced Quality Assurance (QA) professional to join... ...our internal GMP Cell therapy manufacturing. This position... ...will be based in our cGMP Manufacturing site in... ...chain teams with QA/Compliance guidance and decisions... ...non-conformances, and lead the strategic discussion...SeniorWork at officeLocal areaFlexible hours$120k - $140k
...Senior Manufacturing Engineer Woburn & Allston, Massachusetts... ...of next-generation therapies, starting with GLP-1.... ...quality, regulatory compliance, and operational excellence... ...who can independently lead complex technical... ...Strong understanding of cGMP regulations and for pharmaceutical...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 regulatory compliance. Lead process... ...Ishikawa). Knowledge of cGMP, and quality and regulatory...Senior$200k - $260k
...vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients.... ...are seeking a Director/Senior Director, Quality... ...Quality Assurance and GxP Compliance to be a key leader within... ...efficiency. Provide QA oversight of GxP computerized...SeniorContract workTemporary workFlexible hours$272k - $340k
...commercialization of transformative therapies for patients with autoimmune... .... Obexelimab, Zenas’ lead product candidate, is a bifunctional... ...are broadly present across B cell lineage, to inhibit the... ...activities. This role partners with Compliance to ensure that the Company’s...Flexible 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-functional teams to develop, qualify, and transfer assays supporting clinical manufacturing and...Senior
$31.25 - $38 per hour
...are pioneers in advanced cell therapies for sports medicine and... ...therapy products in compliance with internal and regulatory... ...comply with SOPs, cGMP requirements, and maintain... ...- functionally with QA, QC, R&D, Materials Management... ...staff; partner with Leads and management to...Hourly payFor contractorsWeekend work- 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
- Sana Biotechnology, Inc. is hiring a Senior Director for Late-Stage Cell Therapy Process Development in Cambridge, MA. You'll oversee... ...The role involves managing a team, ensuring compliance with regulatory standards, and leading process validation activities. Ideal...Senior
- ...commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s degree, extensive experience...SeniorRemote work
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