Associate Director/Director, Supply Chain

Azalea Therapeutics•Berkeley, CA

11d•Hybrid

About The Position

Azalea Therapeutics is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo. Azalea is pioneering a new way to turn a person’s own T cells into a powerful cancer therapy — directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles, or EDVs. As highly selective couriers, EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell, the anti-cancer agent is inserted into a precise site in the genome, ensuring safe and potent modifications to fortify the T cells against cancers. Why this matters: We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body. Our platform is designed for precision, so the right cells are safely programmed to effectively fight cancer. This technology has the potential to treat a wide range of cancers with a streamlined, scalable process. Our goal is simple: develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients. How We Work Azalea is building ambitious science in a fast-moving environment. The people who thrive here are accountable, adaptable, rigorous, humble, and direct. Across roles and functions, we look for team members who demonstrate the following: Outcome Ownership - We own results, close loops, and follow through without needing to be prompted. We take responsibility for moving work forward and making sure important decisions, deliverables, and handoffs do not fall through the cracks. Comfort with Ambiguity - We operate in an early-stage environment where information may be incomplete and priorities may evolve. We clarify quickly, make thoughtful decisions with the information available, and adapt without unnecessary drama. High Standards, Low Ego - We care deeply about the quality of the work and the impact it can have for patients. We raise the bar while staying humble, direct, and open to feedback. Collaboration and Candor - We share context early, communicate clearly, partner across functions, and operate with transparency. We believe strong collaboration requires both trust and direct communication. 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.

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.

Nice To Haves

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.

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.