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media process development cgmp cell therapy supplier qualification📋 Description
- Based in Toronto, ON or Cambridge, MA; lead lifecycle mgmt of raw materials.
- Own characterization, qualification, and ongoing monitoring of raw materials.
- Support clinical ops with deviation investigations, OOS/OOT, CAPA.
- Author raw material process and overall control strategy.
- Chair Raw Material Review Committee; coordinate with Supply Chain & vendors.
- Reports to VP Engineering & MSAT; collaborate across functions.
🎯 Requirements
- Bachelor’s in life sciences; 13+ yrs, 11+ in biopharma.
- MS/PhD/Eng Doc in Science/Engineering preferred.
- Deep knowledge of cell culture media, single-use systems, CGT materials.
- Extensive experience with cell/gene and biologics process development and cGMP.
- Experience with CGMP regulations and regulatory inspections.
- Strong interpersonal, planning, and cross-functional skills.
🎁 Benefits
- Hybrid work arrangement.
- Equal opportunity workplace.
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