Senior Manager, Patient Operations
About the Company : Our client is a Bay area cell therapy biotech developing therapeutics for autoimmune and inflammatory diseases.
About the Role : The Senior Manager, Patient Operations will be responsible for onboarding and managing a network of Apheresis Centers for autologous cell therapies and for sourcing and procuring cell sources for allogeneic cell therapies.
Required experience and skills :
- Bachelor’s Degree in life sciences field 8+ years of experience in a regulated environment either hospital or pharmaceutical / biotech or apheresis and / or cell therapy operations management
- Strong knowledge of applicable regulations and standards related to Cell Therapies, Cell Collection, and Donor Requirements
- Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs
- Experience working in a regulated environment (cGMP / GCP / GTP) preferred
- Good knowledge of international standards for cell collection and donor requirements.
Primary responsibilities :
- Manage the network of cell collection facilities including sourcing, verification of capabilities, and monitoring performance
- Manage the on-boarding and continued performance of the collection centers according to program plans and strategy
- Scout and support sourcing of collection centers internationally
- Communicate apheresis centers on-boarding status to internal teams and develop and execute mitigation plans for delayed timelines as requested
- In close collaboration with Clinical Operations and Technical Operations, define the requirements for cells as starting materials for cell therapy programs.
Manage the requirements as they evolve through progression in the clinical development phases and changes in regulatory requirements.
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