Associate Director/Director, Supply Chain

About Azalea Therapeutics

Azalea Therapeutics advances precision genome engineering directly within the body, focusing specifically on cancer immunotherapies in vivo. Their innovative technology programs T cells inside the patient using Enveloped Delivery Vehicles (EDVs), which selectively deliver genome editing cargo to T cells. This approach enables direct and precise genetic modification, enhancing the immune response against cancer through targeted cell therapy without external cell manipulation.

Work Culture and Values

• We encourage ownership of outcomes, ensuring accountability to complete tasks and secure effective handoffs.
• Comfort with ambiguity is crucial, as priorities may change and decision-making often occurs with incomplete information.
• We uphold high-quality work standards combined with humility and openness to feedback.
• Collaboration based on clear and transparent communication across teams is essential.

Role Overview

The role entails senior leadership in global supply chain planning and operations for early-stage cell and gene therapy projects, reporting to the VP of External CMC Operations. You will oversee materials flow, product lifecycle, and coordination across multiple departments, supporting clinical and manufacturing processes.

Key Responsibilities

• Lead end-to-end supply chain planning for in vivo gene therapy from preclinical development through late-stage clinical trials, aligning supply with clinical and manufacturing timelines.
• Manage procurement, forecasting, inventory, and distribution for plasmids, viral vectors, cell banks, drug products, and other critical components supporting multiple clinical studies.
• Collaborate with CMC, Clinical Operations, Quality, and Regulatory Affairs to develop and approve labeling and packaging specifications for global regulatory filings.
• Oversee partnerships with CMOs, CDMOs, logistics providers, and depots, monitoring their performance via KPIs and ensuring quality standards.
• Facilitate secondary packaging and labeling processes with partners, including release and global product distribution.
• Lead cross-functional supply planning meetings to support milestone deliveries and manufacturing preparedness.
• Continuously refine SOPs and supply chain processes to enhance scalability and compliance with GxP standards.
• Develop risk mitigation and supply strategies addressing long-lead components and critical supplier dependencies.
• Execute logistics and planning to guarantee uninterrupted clinical product delivery to study sites worldwide.
• Manage offsite GMP storage facilities, inventory control, and distribution mechanisms to clinical sites and depots.
• Collaborate on clinical pharmacy manuals concerning drug packaging, shipping, handling, and infusion formulation.

Candidate Profile and Qualifications

• Bachelor’s degree in Supply Chain Management, Operations, Life Sciences, Engineering, or related discipline required; Master’s preferred.
• 8 to 12 years of relevant experience in clinical supply chain or technical operations within biotech or pharmaceutical sectors, with direct exposure to cGMP clinical supplies from early development through pivotal trials.
• Proven track record managing supply chain functions including clinical supply planning, procurement, inventory control, and global distribution.
• Experience managing relationships with contract manufacturers, depots, and logistics partners.
• Adept at developing scalable, compliant SOPs and processes in fast-paced startup or growth-stage biotech environments.
• Strong project management, leadership, communication, and stakeholder engagement capabilities.
• Preferred experience includes people management, IND-enabling studies, cell and gene therapy supply chains, and global regulatory knowledge related to packaging and labeling.

Early Success Metrics

• Build understanding of complex logistics supporting Azalea’s gene therapy platform.
• Develop and implement international shipping protocols.
• Initiate evaluation and selection process for packaging and labeling CMOs.
• Establish productive relationships with plasmid, cell line, and vector manufacturing partners.
• Create a harmonized global labeling strategy for clinical trials.

Working Conditions & Requirements

• This role requires approximately 2–3 days per week working onsite in Berkeley, CA, with additional presence as needed.
• Travel up to 15% to company events, meetings, and training.
• Ability to stand and sit for extended periods to fulfill job functions.

Compensation and Benefits

• Annual salary range is $175,000 to $215,000, depending on experience and location.
• Eligible for performance bonuses, equity grants, and comprehensive medical, dental, vision, retirement plan with matching, and paid time off.

Equal Employment Opportunity and Additional Notes

Azalea Therapeutics is an equal opportunity employer and committed to providing accommodations for disabilities and sincerely held religious beliefs. Candidates are advised to beware of fraudulent job offers; all official communications will be from @azaleatx.com email addresses. This job description may be updated as business needs evolve, and it does not constitute a contract of employment.