Associate Director, Analytical Development ​/ Quality Control

Job Title: Associate Director, Analytical Development / Quality Control

Department: External CMC Operations Reports to: VP of External CMC Operations Location: Hybrid Role, Onsite 3-5 days per week in Berkeley, CA Employment Type: Full-time FLSA Status: Exempt Bonus/Equity: Eligible

About Azalea

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.

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.

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 - 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

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,…