Associate Director/Director, Supply Chain

About the role

The Associate Director/Director, Supply Chain, External CMC Operations will lead global supply chain planning and execution activities supporting early-stage cell and gene therapy programs. Reporting to the VP External CMC Operations, this individual will play a critical role in ensuring the seamless flow of materials, products, and information across research, process development, manufacturing, quality, and the clinical operations functions.

Responsibilities

• Lead supply chain planning and execution for in vivo gene therapy programs from pre-clinical development through pivotal clinical stage programs
• Develop and maintain integrated clinical supply plans aligned with manufacturing schedules, clinical enrollment forecasts and study timelines
• Manage procurement, forecasting, inventory, and distribution of critical materials including plasmids, viral vectors, cell banks, finished goods, drug products, drug substances and other critical components across multiple clinical programs
• Collaborate with CMC, Clinical Operations, Quality and Regulatory Affairs to generate label/package specifications, oversee approvals for multiple countries/regions, and provide support for IND/IMPD/CTA filings as required
• Manage relationships with CMOs, CDMOs, depots, logistics providers and other external supply chain partners to ensure quality, delivery and performance expectations are met; Establish KPIs and monitor vendor performance
• Plan and oversee the secondary packaging, labeling activities with CMOs, and facilitate the process through release and global distribution
• Lead cross-functional supply planning meetings and partner closely with Technical Operations, Manufacturing, Process Development, Quality, Regulatory Affairs and Clinical Operations teams to support development milestones and manufacturing readiness
• Develop and continuously improve supply chain processes, SOPs, and documentation to support organizational growth and GxP compliance
• Develop supply strategies and risk mitigation plans for long-lead time materials and critical suppliers
• Responsible for clinical supply planning and logistics to ensure uninterrupted delivery of investigational products to clinical sites
• Manage offsite GMP storage partners and manage inventory
• Work collaboratively with CMC and clinical operations to draft the clinical pharmacy manual for packaging, shipping, receiving, storage and formulation of drug products for infusion

Requirements

• BS/BA in Supply Chain Management, Operations, Engineering, Life Sciences, or a related field
• 8–12 years of experience in clinical supply chain, manufacturing operations, or technical operations within the biotechnology or pharmaceutical industry
• Proven experience supporting cGMP clinical supply chains from preclinical through pivotal studies
• Knowledgeable in building processes and infrastructure in a fast-paced startup or growth-stage biotech environment
• Proven experience with clinical supply planning, forecasting, procurement, inventory management, and global distribution of investigational products
• Experience managing CMOs, CDMOs, depots, logistics providers, and other external supply chain partners
• Proven experience developing and implementing supply chain SOPs, processes, and documentation to establish scalable, GxP-compliant operations in a growing biotech environment
• Strong sense of ownership and accountability with the strength of balancing strategic planning with day-to-day execution
• Experience supporting global clinical trials and international shipment/distribution of investigational products
• Strong project management, organizational, communication, collaboration, and stakeholder management skills with a hands-on, solutions-oriented approach

Qualifications

• MS in Supply Chain Management, Operations, Engineering, Life Sciences, or a related field (preferred)
• Prior people management experience or demonstrated ability to lead cross-functional teams and external vendors (preferred)
• Experience establishing supply chain infrastructure within an early-stage biotechnology company (preferred)
• Experience supporting IND-enabling pivotal clinical studies (preferred)
• Experience with cell and gene therapy supply chains, particularly with shipment of plasmid, cells and viral vectors for in vivo gene therapies (preferred)
• Solid understanding of global regulatory requirements for clinical supplies with experience applying them to packaging/labeling and distribution operations (preferred)