Associate Director, Analytical Development ​/ Quality Control

Associate Director, Analytical Development / Quality Control

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.

Our goal is simple: develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients.

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
• Comfort with Ambiguity
• High Standards, Low Ego
• Collaboration and Candor

The Opportunity

Azalea is seeking a scientifically rigorous and execution orientated Associate Director, Analytical Development / Quality Control to own the external analytical and quality-control capabilities required to advance the pipeline toward first-in-human readiness and support the company's future pipeline. Reporting to the VP, External CMC Operations, the immediate focus for this role will be establishing phase-appropriate analytical strategies and ensuring assay, testing, release, stability, and external laboratory readiness for planned EDV and AAV manufacturing activities.

This is a highly external-facing technical and program leadership role that will work side by side with the internal analytical development team. This leader will ensure that external CRO and CDMO activities are planned, governed, reviewed and delivered on schedule and within compliance of all regulatory requirements for early phase clinical trials. They will bridge internal assay development with external transfer and execution.

They will drive method implementation and phase appropriate qualifications, critically reviewing all development reports and data packages.

This role is aligned with Azalea's Associate Director level and will lead a significant functional area with accountability for outcomes. The Associate Director shall combine deep analytical judgement with exceptional vendor management and operational discipline. They will shape analytical plans and priorities, manage ambiguity, influence cross-functional decisions, guide internal contributors and external partners, and connect execution to company goals. The role may directly manage employees as the function grows and is expected to deliver through a combination of internal expertise, consultants, contract laboratories, and CDMO teams.

The ideal candidate is a hands-on analytical leader who can establish strategy while also reviewing data, troubleshooting methods, strengthening external execution, and building practical systems. The successful candidate will identify risks early, maintain a clear view of assay readiness across programs and manage outsourced testing that supports process development, lot release, stability, comparability and regulatory filings. This person should be able to balance scientific rigor, GMP expectations, speed, resource constraints, and the need for decision-quality data in an early-stage biotechnology company.

This is a hybrid role, onsite 3-5 days in our Berkeley, CA office, depending on project needs. In addition, this role is expected to travel to CRO/CDMO's as needed during tech transfer and GMP operations.

Key Responsibilities

• Own the integrated external analytical plan across Azalea programs, including assay scope, development, documentation review and qualification timelines, as well as managing the budget, capacity dependencies, and…