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Job Title : Manager/Senior Manager, CMC Quality Control Writer and Reviewer. The individual in this role will be the analytical, technical, and quality operational subject matter expert (SME) for QC CMC writing, review and assist in Regulatory filings (ICH/Compendial/FDA and EMA.
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Attend CMO and internal CMC team meetings and provide quality feedback supporting Alumis products including collaborations on complex investigations. The Director will be responsible to provide the quality operational support for the CMC teams and support the quality organization in building the Alumis quality systems and processes.
$220,000 - $233,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The position will also assume a key leadership role in the establishment of CMC control strategies for Sana’s pipeline. As a Senior Director Gene Editing Technologies within the Analytical Development department, you will report to the Vice President Head of Analytical Development and lead a function accountable for establishing deep characterization and knowledge of gene editing technologies used in the manufacture Sana’s cell therapy products.
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Maintaining the overall schedule of nonclinical studies system to track the entire workflow of nonclinical studies and archival of study-related materials; collaborate with the Biology, Medicinal Chemistry, and CMC leads to create and maintain timelines for nonclinical studies.
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The candidate may work on any functional sub team depending on need, including CMC, Clinical, Research or Regulatory. Experience in a CMC discipline is preferred. This position will partner with functional sub-team leaders to lead project management activities for a cell therapy program sub-team, guiding the sub-team through preclinical and clinical development.
$145,000 - $175,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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We are seeking an experienced and highly motivated small molecule formulation scientist with a proven record of sustained laboratory achievement and innovation to join our growing Department of Pharmaceutical Sciences (PharmSci/CMC.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Alumis is hiring a Senior Manager of GMP Quality Assurance working closely with the CMC Team to ensure quality oversight of external suppliers and contract manufacturing organizations (CMOs) activities.
$170,000 - $190,000 a yearFull-timeExpandUpdated 7 days ago - UpvoteDownvoteShare Job
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You will be reporting to our Chief Scientific Officer & Head of Research, and you will manage a team of research biologists and project team leaders and work across teams including Antibody and Protein Engineering, Nonclinical sciences, Tech Ops, and CMC.
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Develop and lead CMC Regulatory strategies for a portfolio of programs in development, including AAV gene therapies and small molecule drugs. Align CMC regulatory strategy to overall regulatory business strategy (e.g. viral vector upcoming process, raw material, shelf-life and analytical changes.
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B.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics or related scientific discipline with a minimum of 5 years of direct CMC analytical development experience in biotech/pharma or M.S. with a minimum of 3 years of direct CMC analytical development experience in biotech/biopharma or Ph. D. with 2 years of directly relevant experience.
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Author sections of the CMC modules in support of regulatory submissions. Communicate strategies and provide status updates to the broader CMC team. A highly collaborative and team-oriented approach to leadership, a high level of self-awareness, and a passion for making a meaningful contribution to cell or gene therapy through your work.
$170,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Created in 1983, CMC now manages over 2,000 affordable housing units for MHDC and various other non-profit, community based organizations in San Francisco. San Francisco ONLY: CMC will consider qualified applicants with a criminal history pursuant to San Franciscos Fair Chance Ordinance.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Collaborate with Analytical Research and Development teams to elucidate structure/function molecular characterization and interact cross-functionally with teams from Discovery, CMC, QC, and more.
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Experience with Enterprise systems across numerous business lines (e.g. Research/Labs, Clinical Development, Regulatory, CMC, Quality, Finance, HR, Legal) Reporting to the Head of IT, this position will be responsible for serving as a Business Partner with business leaders across all business lines in the company to assess current technology capabilities and perform short term and long-term planning for technology needs.
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A recognized biopharmaceutical company in California is currently seeking an experienced professional to join their CMC Quality Control Department as their new Manager or Senor Manager. In this role, the Manager / Senior Manager will be responsible for all aspects of the CMC QC program(s) support for the company's commercial and clinical programs, including all.
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cmc job in San Francisco, CA
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