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Quality

Senior QC Manager, Potency and Functional Assays

  • Cambridge, MA
  • Added
E01c990f A7d6 4448 Ba29 496D26929ee1

Position Overview:

We are seeking a motivated Sr. Manager to lead the Potency and Functional assay team driving method transfer, qualification, and validation and routine GMP execution of cell-based potency and functional assays for cell and gene therapy products. The individual will be responsible for managing the internal potency and functional assay group as well as external GMP release and stability testing oversight.  This role requires strong working knowledge of cell handling and maintenance techniques of primary and immortalized cell lines, experience executing flow cytometry, cell count and viability ddPCR, and ELISA methodologies, and comprehension of ICH/USP guidelines and potency matrix/assurance approaches.  Ideal candidate will also have experience working with hematological samples and next generation sequencing (NGS).  This role will play a critical role in supporting the advancement of Beam’s cell and gene therapy candidates from early phase to commercialization.

Primary Responsibilities:

  • Lead the development, optimization, qualifications, and validation of cell based and functional assays used for lot release and characterization of cell and gene therapy products and critical materials.
  • Manage a team of QC laboratory analysts performing GMP testing.
  • Onsite presence required to ensure appropriate GMP testing oversight.
  • Independently design technical transfer, qualification, and validation protocols to support both internal and external QC methods.
  • Work with external partners to ensure successful transfer and execution of release and stability testing.
  • Identify assay improvement opportunities, and design and execute studies to support assay improvements and process improvements over the lifecycle of the product.
  • Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
  • Work cross-functionally with R&D, Analytical Development, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigations.
  • Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify assay improvements throughout the assay life cycle.
  • Laboratory experiment execution may be required for specific high priority activities.

Qualifications:

  • Degree in Life Sciences, Immunology, Chemistry, or related discipline with 10+ (BS) years of relevant experience.  Advanced degrees (MS, PhD, etc) may reduce the total years of experience required.
  • 3 to 5 years of managerial experience leading a team of laboratory scientists required.
  • Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, flow cytometry, cell counting and viability, ddPCR/qPCR, ELISA, and NGS is a plus.
  • Experience using data analysis software including JMP and PLA software.
  • Experience with executing GMP release and stability testing and QC laboratory protocols and procedures.
  • Broad knowledge of ICH/USP guidelines
  • Excellent organizational skills towards multi-tasking in an extremely fast-paced environment
  • Team player with excellent oral and written communication skills
  • Independently motivated, detail-oriented, and excellent problem-solving abilities
  • Domestic and international travel may be required to external CTLs and other Beam sites.

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