Head of CMC Quality, Cell Therapy and Regulatory Leadership
BrainChild Bio, Inc.
BrainChild Bio in Seattle is seeking an experienced Director, CMC Quality to provide strategic quality leadership across development and lifecycle management of its cell therapy programs. As the CMC Quality lead, you will shape phase-appropriate quality oversight, robust control strategies, and regulatory compliance throughout the product lifecycle. You will collaborate with Process and Analytical Development, MSAT, Regulatory Affairs, Supply Chain and external partners to ensure risk-based #J-18808-Ljbffr BrainChild Bio, Inc.
- BrainChild Bio, Inc. is seeking a Director, Regulatory Affairs, CMC to lead global regulatory CMC strategies across our clinical-stage cell therapy programs. You will guide program teams, prepare CMC and quality-related agency communications, and ensure compliance with...Regulatory
- Moonlight Bio, Inc. seeks a Senior/Principal Scientist for Process Development and CMC in Seattle. The role focuses on advancing cell therapy manufacturing, process characterization, and regulatory submissions while ensuring material supply continuity and strong...RegulatoryFreelance
- ...Senior Manager or Associate Director of Regulatory Affairs to drive clinical regulatory... ...and submissions for in vivo CAR-T and cell/gene therapy programs. This role involves global health... ...medical writing, pharmacovigilance, and CMC teams. The candidate will plan FDA/EMA...Regulatory
- BrainChild Bio is seeking a Director, Regulatory Affairs, CMC , to support implementation of the... ...CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a kids-first... ...meets the highest standards of quality, safety, and reliability. The Director...RegulatoryContract workShift work
- Director, CMC Quality BrainChild Bio is seeking an experienced Director... ...provide strategic quality leadership across the development and... ...management of its cell therapy programs. This role serves... ...Operations and compliance with regulatory requirements throughout the...RegulatoryContract work
- ...Description: We’re looking for a hands-on quality leader to take X-BAT from early... ...meet technical, customer and applicable regulatory requirements. We need a technically credible... ...as production scales. Give leadership a clear view of quality performance, product...RegulatoryFull timeTemporary workPart timeWorldwide
$152.36k - $184.63k
...and the careers of those who do it. The Cell Therapy Thematic Research Center is one of BMS'... ...to patients. Our mission is to drive leadership in the use of cellular therapies to harness... ...well as contribute to relevant global regulatory submission activities to advance...RegulatoryHourly payFull timeContract workSummer workLive inRemote workFlexible hours$249.9k - $308.7k
...develop off-the-shelf therapies capable of treating... ...Senior Director, Regulatory Affairs reports to the Head of Regulatory Affairs... ...deep experience in cell & gene therapy and a... ...provide regulatory leadership and oversight for ongoing... ..., clinical, CMC Regulatory, and technical...RegulatoryWorldwide- Bristol Myers Squibb seeks a Launch Manager for the Cell Therapy Launch and Lifecycle Management Excellence Team in Seattle, WA. You... ...of complex programs, risk identification, and adherence to quality/regulatory requirements within a global matrix organization. #J-18808...Regulatory
- ...vectors, mRNA, and lipid nanoparticle systems used in gene therapy and cell engineering. The role emphasizes biophysical stability, freeze... ...with external CMOs and CROs; author technical and regulatory reports Requirements Demonstrated expertise in biophysical...Regulatory
- ...Senior Scientist in Drug Product Analytical Science (ASAT) for Cell Therapy. The role will conduct bench experiments and provide... ...analyze data, and contribute to method transfer, validation, and regulatory submissions while training team members and guiding cross-functional...Regulatory
$152.36k - $184.63k
...Scientist to lead translational biology research for clinical-stage cell therapy assets in oncology and autoimmune indications. The role... ...biomarker strategies, and generating data to support regulatory submissions and clinical decision-making. Responsibilities...Regulatory$152.36k - $184.63k
...seeks a Principal Scientist to lead translational research for cell therapy clinical trials in autoimmune and inflammatory diseases. The... ...experiments, managing collaborators, and supporting regulatory submissions for cellular therapy programs. Responsibilities...Regulatory$99.38k - $120.43k
...provide technical expertise for cellular therapy quality control. The role involves designing... ...analytical method lifecycle management and regulatory compliance. Responsibilities... ...maintain laboratory methods and protocols for cell therapy products Author and review...Regulatory- Aurion Biotech Inc. is seeking a Senior Quality Associate for a fully remote role based... ...CDMOs and CTLs to ensure compliant cell-therapy products. Requirements include a Bachelor... ...experience, with strong documentation, regulatory knowledge, and MS Office skills. #J-18...RegulatoryRemote job
$168.93k - $204.7k
...analytical method lifecycle management within Cell Therapy, including validation, transfer, and... ...technical expertise and strategic leadership across global quality initiatives, partnering with development, manufacturing, regulatory, and external stakeholders. Responsibilities...Regulatory$152.36k - $184.63k
...production line to the latest breakthroughs in cell therapy, this is work that transforms the lives... ...to patients. Our mission is to drive leadership in the use of cellular therapies to... ...) to support project milestones and regulatory/patent filings. Experience = Basic Qualifications...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$88.79k - $133.18k
...Cell Processing Laboratory Support This is an exciting position... ...for clinical cell therapy applications that are moderately... ...processing, cryopreservation, and Quality Control (QC) of therapeutic cellular... ...the preparation of reports, regulatory submissions, and the drafting...RegulatoryFull time- ...to develop off-the-shelf therapies capable of treating any... ...The Vice President, Head of Portfolio & Program Strategy... ...strategic portfolio leadership with operational rigor,... ...Development, Clinical Operations, CMC/Technical Operations, Regulatory, Quality, Translational Medicine,...RegulatoryWork at officeImmediate start2 days per week
$210k - $245k
...organization seeking a Director, Quality Control to join our CMC team. The Director,... ...Control will provide strategic leadership in managing a growing team... ...of hematopoietic stem cell transplant-associated... ...review relevant sections of regulatory filing reports and submissions...RegulatoryContract workFor contractorsLocal area- ...Officer (CMO) About the Company Late-stage cell therapy company with significant recent financing and near-term regulatory milestone. Industry Biotechnology... ...story in late-stage biotech. This executive leadership position requires a physician-scientist or physician...Regulatory
$159.8k - $197.4k
...develop off-the-shelf therapies capable of treating any... ...Associate Director, Clinical Regulatory Affairs will support... ...in vivo CAR T and cell and gene therapy programs... ...writing, pharmacovigilance, CMC, nonclinical, program... ...to ensure high-quality, timely regulatory deliverables...RegulatoryWork at office2 days per week- Bristol Myers Squibb's Cellular Therapy Translational Biology Research group in Seattle, WA, seeks an experienced Principal Scientist... .... You will design experiments, generate data to support regulatory decisions, collaborate across disciplines, and mentor junior scientists...Regulatory
- ...reality technologies. Job Description: We’re looking for a hands-on quality leader to take X-BAT from early prototype builds through... ...deliver aircraft that meet technical, customer and applicable regulatory requirements. We need a technically credible leader who can build...Regulatory
- .../ Associate Director, CMC Formulation Development... ...innovative biologic therapies in a collaborative, fast... ...manufacturing, and regulatory submissions. · Partner... ...process development, quality, regulatory, and program... ...project teams and leadership. · Experience working...RegulatoryFull timeRemote work
$210.86k - $242.79k
Director, Patient Services Strategy, US Cell & Gene Therapy Office Location: Gaithersburg, MD (3 days minimum per week) Remote is not available... ...enterprise. Key Responsibilities Enterprise Accountability Leadership: Own the US Patient Support strategy and operating model,...Hourly payTemporary workWork at officeRemote work3 days per week$124.19k - $150.48k
...systems—used in gene delivery, gene editing, and engineered cell therapy programs. The role focuses on the biophysical and colloidal stability... ...materials. Author technical reports and contribute to regulatory documentation, staying abreast of evolving global regulations...RegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours$117.15k - $141.96k
...Product Analytical Science (ASAT), Cell TherapySeattle 400 Dexter -... ...supporting the Cellular Therapy product portfolio. Successful... ...validation in compliance with global regulatory requirements.· Responsible... ...methods in the Cell Therapy Quality organization.· Implement...RegulatoryHourly payFull timeSummer workLive inLocal areaImmediate startRemote workFlexible hours- ...the nation’s largest contract therapy providers, Reliant offers... ...growth opportunities. Our leadership team began their careers as therapists... ...ensuring compassionate, high-quality care in accordance with... ...ensure care meets clinical and regulatory standards Deliver care...RegulatoryContract workFlexible hours
- ...the nation's largest contract therapy providers, Reliant offers... ...growth opportunities. Our leadership team began their careers as therapists... ...(PT), ensuring high-quality care and positive engagement... ...ensuring care meets clinical and regulatory standards. • Follow infection...RegulatoryFull timeContract workReliefFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Head of CMC Quality, Cell Therapy and Regulatory Leadership. Be the first to apply!
- vice president of quality Seattle, WA
- quality tech Seattle, WA
- air quality Seattle, WA
- water quality Seattle, WA
- quality improvement rn Seattle, WA
- aerospace quality Seattle, WA
- quality manufacturing Seattle, WA
- quality Seattle, WA
- quality distribution Seattle, WA
- quality assurance quality control engineer Seattle, WA





