Quality Control Director

107595
  • Competitive
  • West Hills, United States
  • Permanent

About:

Clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer. We are biologics focused with novel approach to (CAR)-T cell therapies including relapse due to antigen loss/escape; on target, off tumor toxicities; and the immunosuppressive tumor microenvironment.

 

Our lead program, a bispecific "OR-gate" CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far.

 

Looking for an exceptional individual to join the growing team as a Quality Control Microbiology Supervisor.

Primary responsibilities:

  • Manage a team of QC professionals to support GMP testing of cell and gene therapy products
  • Monitor lab operations
  • Provide leadership in the development and qualification of analytical methods and specifications
  • Author IND CMC sections and internal documentation
  • Manage internal and contract analytical test labs

Qualifications:

  • 6+ years of Quality Control/Analytical Development experience in the biotech or pharmaceutical industry with cell and gene therapy
  • Masters degree in Science or Engineering, PhD preferred
  • Experience with analytical test methods
  • Knowledge of regulatory requirements
Nick Lloyd Resourcer

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