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
Team Lead, Cryo Operations (Manufacturing)
Builds
Cell Therapy products (CAR T)
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
cGMP compliance, batch record review, cryopreservation operations, liquid nitrogen storage management, team leadership, deviation investigation, change control, CAPA management, ALCOA+ principles
Preferred skills
Cell therapy background, cold chain operations, EBR/MES/SAP systems experience
Technologies
EBR, MES, SAP
Responsibilities
Oversee cryopreservation and patient material handling across shifts; ensure compliance with FDA, OSHA, and cGMP standards; manage LN2 storage and inventory; review batch records and resolve discrepancies; lead team training and performance management; support deviation investigations and CAPAs; align team execution with production schedules.
Seniority
Mid-level Lead (3+ years experience, 1+ year leadership)