Job Title: Associate Director/Director, Supply Chain

Department: External CMC Operations
Reports to: VP of External CMC Operations
Location: Hybrid- 2-3 days per week expected onsite in Berkeley, CA
Employment Type: Full-time
FLSA Status: Exempt
Bonus/Equity: Eligible

The Opportunity

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

What Success Looks Like (first 3-6 months)

• Understand the complex logistics involved with Azalea's technology.
• Begin to establish shipping procedures for various countries.
• Identify and obtain multiple proposals from packaging, labeling and distribution CMO's.
• Establish relationships with the current plasmid, cell line and vector CDMO's.
• Establish a universal labeling strategy to support global clinical trials.

Working Conditions / Physical Requirements (as applicable)

• Willingness to travel, up to 15%, as needed for company meetings, conferences, training or other business-related activities.
• Ability to sit and stand throughout the day to complete the job's responsibilities.

Compensation and Benefits

• The expected salary range for this role, based on the primary location for this position in California, is $175,000-$215,000per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law. Salary will be commensurate with experience, qualifications, training and market.
• This role is eligible for annual performance bonuses, equity grants, and a comprehensive benefits package that includes medical, dental, vision, retirement plan with company match, and paid time off.