Associate Director, Site Supply Chain - Materials Management
Core
Lead patient and healthy donor materials management, ensuring Chain of Identity (COI) and Chain of Custody (COC) from apheresis to drug product pack-out for autologous and allogeneic cell therapies.
Role type
Senior IC site supply chain manager (cell therapy)
Builds
Patient and donor material flow, traceability, and GMP-compliant drug product pack-out
Domain
Biopharma / Cell Therapy / GxP
Required skills
Cell therapy COI/COC controls, GMP/GDP/GxP compliance, exception management, operational investigations, corrective action leadership, schedule coordination, root cause analysis
Preferred skills
MS/MBA, 24/7 monitoring environment experience, Power BI/Excel/Smartsheet, new country/study launches
Technologies
Digital systems for milestone visibility, Power BI, Excel, Smartsheet
Responsibilities
Lead patient materials management across autologous programs; Lead healthy donor materials management across allogeneic programs; Coordinate apheresis receipt and drug product pack-out schedules; Own COI/COC process including SOPs and real-time monitoring; Ensure execution discipline for traceability workflows; Support operational readiness and hypercare for new studies; Lead exception management and escalation; Support fact-finding investigations and CAPAs; Track operational metrics and identify improvement opportunities
Seniority
Senior, hands-on IC