Materials Supply:

• Ensure materials and drug product shipments align with manufacturing schedules and patient treatment timelines. 

• Coordinate activities for supplying GMP material for manufacturing, laboratory and facility operations 

• Support receipt, inspection, storage, and distribution of GMP materials. 

• Ensure proper inventory control within ERP/MES/WMS systems. 

• Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. 

Cold Chain Management:

• Oversee cryogenic and cold chain storage systems, including LN2 freezers and associated monitoring systems. 

• Supervise drug product cryopreservation handling and storage workflows. 

• Ensure compliant pack-out and shipment of cold chain drug products using validated shippers. 

• Coordinate shipments with couriers and logistics partners. 

• Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. 

Supervision:

• Ensure operations comply with: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GTP (Good Tissue Practices) where applicable and Internal SOPs and regulatory requirements 

• Support quality investigations, deviations, CAPAs, and change controls. 

• Ensure proper documentation, batch record completion, and data integrity. 

• Support internal and external regulatory inspections and audits. 

• Supervise and develop a direct reports 

• Promote a safety-first and quality-first culture. 

• Identify and implement process improvements in material flow, inventory control, and shipping operations.