Warehouse Specialist
Core
Manage warehouse operations for clinical cell therapy drug product manufacturing, ensuring chain-of-identity, cold chain integrity, and GMP compliance for patient-specific materials.
Role type
GMP Warehouse Specialist (Cell Therapy)
Builds
Patient-specific kits, cryogenic shipments, and validated material movements for manufacturing runs.
Domain
Biopharmaceuticals / Cell Therapy / GxP
Required skills
Cryogenic handling, GMP/GDP compliance, Chain-of-custody management, WMS/ERP data entry, FEFO inventory control, Quality documentation, Equipment qualification support, Biosafety protocols
Preferred skills
Lean/5S improvement, Audit readiness, Cross-functional coordination
Technologies
WMS, ERP, eQMS, LN2 vapor-phase dewars, Ultra-low freezers
Responsibilities
Maintain chain-of-identity and custody for patient materials; Manage cryogenic and cold-chain storage; Execute GMP kitting and line-side delivery; Coordinate patient-specific shipments; Support deviation/CAPA and audit readiness.
Seniority
Mid-level, hands-on IC