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Senior Manager of MSAT

Company: Meet
Location: Covina
Posted on: January 21, 2023

Job Description:

ABOUT:My client is a privately-owned CDMO focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. They are a small, biotech startup headquartered in Arcadia, CA. Their innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.
Reports to: Associate Director of Process SciencesTravel: Occasional. Less than 10%
POSITION SUMMARY:This role will be responsible for preclinical and clinical manufacturing support, leading a team focused on effective delivery of MSAT operationally focused services for cGMP manufacture of client's cell therapy products, including production support and technology transfer. The successful candidate will have extensive experience with cell/gene therapy processes and procedures.
PRIMARY RESPONSIBILITIES:

  • Developing a strong and deep bench of technical process experts of cGMP cell/gene manufacturing.
  • Responsible for successful transfer of processes (for allogeneic/autologous cell therapies, viral vectors) into production. As such, you are in direct contact with our clients, Process Sciences and Manufacturing teams.
  • Supports the various manufacturing platforms to enable current and new product formats, increased product control, lower cost, and lower operational complexity.
  • Ensure process manufacturability and responsible for continuous improvement of the manufacturing processes
  • Lead tech transfer activities from Process Development/Sciences to cGMP manufacturing, including the following aspects: Equipment, Materials, Process, Documents, Training, Tech Transfer Protocol and Report, Gap assessment and Risk assessment etc.
  • Author and review of tech transfer documents, batch records, and SOP's to support tech transfer and cGMP manufacturing projects
    SKILLS:
    • Demonstrated ability to design laboratory experiments and evaluate data to provide scientific guidance on process optimization
    • Demonstrated ability to technically trouble shoot and resolve manufacturing challenges to successfully produce cell therapy products at a high-performance rate.
    • Demonstrated ability to lead investigations, risk assessments, tech transfer, process monitoring, and routine clinical support; experience with process characterization, PPQ and PV is highly desirable.
    • Capable of suggesting effective CAPA for manufacturing process failures
    • Deep knowledge of FDA regulatory requirements for drug products and IND filing
    • Knowledgeable of cGMP processes and technology transfer
      EDUCATION:
      • Ph.D. in a scientific or bioengineering discipline and 6-8 years of experience or M.S. and 8-10 years experience in MSAT or manufacturing of cell and gene therapies (preferred), vaccines or biologics.
      • At least 5 years experience of managing a technically sound, scientific multi-functional team
      • Minimum of 5 years experience in FDA-regulated industry with experience in evaluating process materials and components in the cell therapy biotechnology industry.
      • Direct experience with cell and gene therapy process execution, IND filing, and supporting clinical products is required.

Keywords: Meet, Covina , Senior Manager of MSAT, Executive , Covina, California

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