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, validated cryogenic shipments, and compliant inventory records for cell therapy manufacturing.
Domain
Biotechnology / Cell Therapy / GMP Manufacturing
Required skills
Cryogenic handling, GMP/GDP compliance, Chain-of-identity/custody control, WMS/ERP data entry, FEFO inventory management, Temperature monitoring, Biosafety protocols, Equipment qualification support, Deviation/CAPA documentation, Cross-functional coordination
Preferred skills
Lean/5S improvement, Audit readiness, Root-cause analysis
Technologies
WMS, ERP, eQMS, Ultra-low freezers, LN2 vapor-phase dewars
Responsibilities
Receive and inspect patient materials and vectors; Manage cryogenic and cold-chain storage; Prepare GMP-compliant kits for manufacturing; Coordinate time-definite patient-specific shipments; Document deviations and support CAPA; Maintain data integrity in electronic systems; Support environmental and equipment qualification; Ensure EHS and biosafety compliance; Prepare for regulatory audits.
Seniority
Mid-level, hands-on IC