Associate Director​/Director, Supply Chain

Associate Director/Director, Supply Chain

We are seeking an experienced Associate Director/Director, Supply Chain, to 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.

The ideal candidate will bring hands-on experience supporting preclinical through pivotal clinical stage programs in a biotech environment, with a strong understanding of the unique supply chain requirements associated with cell and gene therapy products, including raw materials management, global labeling requirements, GMP manufacturing support, cold chain logistics, external partner management, and clinical supply planning. In addition, the successful candidate will be responsible for managing and tracking multiple drug product stability programs and will lead and coordinate all required shipping validation studies.

This is a hybrid role requiring regular onsite collaboration, approximately 2–3 days per week, with additional onsite presence as needed to support business priorities.

Key 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
• Responsible for setting up and establishing methods for distribution of final drug products to clinical sites or country specific depots.
• 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.

Qualifications

• Minimum Qualifications
  • 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…