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Azalea Therapeutics is pioneering precision genome engineering directly inside the body to create cancer immunotherapies in vivo. The company uses Enveloped Delivery Vehicles (EDVs) to deliver genome editing cargo directly to T cells, enabling safer and more accessible cell therapies without complex ex vivo manufacturing.
The Associate Director, Analytical Development & Quality Control will own external analytical and quality-control capabilities required to advance the pipeline toward first-in-human readiness. Reporting to the VP of External CMC Operations, this role establishes phase-appropriate analytical strategies and ensures assay, testing, release, stability, and external laboratory readiness for EDV and AAV manufacturing activities.
Key responsibilities include:
- Leading the integrated external analytical program across all Azalea programs, managing assay scope, development, documentation review, and qualification timelines
- Serving as Azalea's primary external technical lead, managing day-to-day operations with analytical CROs, CDMOs, and specialty testing laboratories
- Collaborating with the internal analytical development team to establish the appropriate analytical assay matrix and method-lifecycle plan
- Driving method implementation and phase-appropriate qualifications, critically reviewing development reports and data packages
- Ensuring external CRO and CDMO activities are planned, governed, reviewed, and delivered on schedule in compliance with regulatory requirements
- Identifying risks early, maintaining clear visibility of assay readiness across programs, and managing outsourced testing for process development, lot release, stability, comparability, and regulatory filings
- Balancing scientific rigor, GMP expectations, speed, resource constraints, and decision-quality data in an early-stage biotech environment
- May directly manage employees as the function grows
This is a hands-on technical and program leadership role requiring deep analytical judgment, exceptional vendor management, and operational discipline. The ideal candidate combines strategic thinking with practical execution, can establish systems while reviewing data and troubleshooting methods, and bridges internal assay development with external transfer and execution. The role is hybrid (3-5 days onsite in Berkeley) with expected travel to CRO/CDMO sites during tech transfer and GMP operations.
