Principal Engineer I​/II, MSAT ​/ Viral Vector Downstream

Principal Engineer I/II, MSAT / Viral Vector Downstream

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.

The Opportunity

Azalea is seeking a Principal Engineer I/II, Manufacturing Science and Technology (MSAT) - Viral Vector Downstream to serve as the senior technical lead for downstream viral vector technology transfer, and manufacturing readiness. Reporting to the VP of External CMC Operations, the immediate focus for this role will be advancing the EDV and AAV manufacturing capabilities required to move pipeline programs toward first-in-human readiness, including pilot runs, engineering runs, and initiation of GMP manufacturing.

This is a senior individual-contributor role aligned with Azalea's Principal Scientist I/II levels. The Principal Engineer will be accountable for the technical direction of a major manufacturing area, not only the execution of assigned activities. This person will work closely with the internal process development teams to define priorities, connect downstream process decisions to program and company goals, provide technical leadership across external manufacturing partners, mentor other contributors, and influence cross-functional decisions with limited oversight.

The ideal candidate is a hands-on downstream process expert who can move between detailed data analysis and broader CMC strategy. This person should be comfortable leading through influence in a lean, externally networked organization, making clear recommendations with incomplete information, and balancing speed, quality, manufacturability, regulatory expectations, and patient-focused progress. They will be responsible for managing the technology transfer of our EDV and AAV manufacturing processes to our external manufacturing partners for the current and future programs.

This is a full-time onsite position at our Headquarters in Berkeley, CA. The incumbent will travel and be onsite at the CDMO during manufacturing.

Key Responsibilities

• Define and lead the external downstream process strategy for Azalea's viral vector programs, with an immediate focus on EDV and AAV manufacturing for Program 1.
• In collaboration with the PD team, assist with downstream process development, optimization, scale-up, and manufacturing readiness activities across clarification, filtration, chromatography, ultrafiltration/diafiltration, formulation interfaces, sterile filtration, hold-time strategy, and other relevant unit operations.
• Establish phase-appropriate process understanding and control strategies, including identification of critical quality attributes, critical process parameters, key material attributes, process risks, and appropriate monitoring approaches.
• Own downstream technology transfer to contract development and manufacturing organizations (CDMOs), including transfer plans, process descriptions, protocols, batch records, training, readiness assessments, and transfer acceptance criteria.
• Provide technical leadership for pilot, engineering, and GMP manufacturing runs. Review data in real time, identify trends or emerging risks, troubleshoot complex process issues, and drive clear decisions and follow-up actions.
• Lead or support investigations of process deviations, manufacturing failures, atypical results, and recurring performance issues. Develop scientifically sound root-cause hypotheses, corrective actions, and risk-reduction plans in partnership with Quality and external manufacturers.
• Work collaboratively with internal PD teams to establish scale-down models that can be used for, process characterization, comparability, and other studies appropriate to Azalea's development stage and program needs.
• Partner closely with Analytical Development and Quality Control teams to define in-process controls, sampling plans, analytical needs, acceptance criteria, and the data required to support process decisions and product release.
• Collaborate with Process Development, Formulation, Quality, Regulatory, Supply Chain, Program Management, Research, and other technical partners to align external manufacturing with integrated CMC and company milestones.
• Provide technical oversight of…