Team Lead, Value Stream Cryo Operations
Core
Provide tactical leadership for cryopreservation, storage, and handling of patient materials in a CAR T manufacturing facility.
Role type
Senior IC operations team lead (cell therapy/cryo)
Builds
Cell Therapy products (CAR T)
Domain
Biopharmaceutical manufacturing (Cell Therapy)
Required skills
cGMP compliance, batch record review, cryopreservation operations, liquid nitrogen storage management, deviation investigation, CAPA management, change control, team leadership, regulatory standards knowledge (FDA, OSHA, DEA, DOT)
Preferred skills
Cell therapy background, cold chain operations, EBR/MES/SAP systems experience
Technologies
EBR, MES, SAP
Responsibilities
Oversee cryopreservation and handling of Cell Therapy products across shifts; ensure compliance with FDA, DEA, DOT, OSHA, and cGMP standards; manage batch record review and exception-based EBR review; maintain hands-on expertise in LN2 storage and inventory control; lead team training and performance management; support deviation investigations and CAPAs; align team execution with production schedules and BioG commitments.
Seniority
Senior, hands-on IC