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Azalea Therapeutics is seeking a Scientist II/Senior Scientist I to lead drug product and downstream development for viral vector programs. Reporting to the VP of Process Development, this role focuses on formulation and fill-finish development for precision genome engineering therapies delivered via Enveloped Delivery Vehicles (EDVs).
Key responsibilities include designing and executing stability studies (real-time, accelerated, stress, freeze/thaw, hold-time) and in-use compatibility assessments. You will develop and optimize formulation buffers and excipients to maintain viral vector potency through processing and storage using Design of Experiments (DoE) approaches. The role requires deep mechanistic investigation into viral vector loss of function—including aggregation, adsorption, and shear/air-liquid interface effects—and proposing mitigation strategies.
Filtration strategy is a core technical ownership area: you will lead selection and optimization of filtration media, evaluate flux limits and product loss, and generate robust scale-down models. Technology transfer is critical—you will collaborate with CDMOs to optimize manufacturing processes, support scale-up activities, and develop in-process control strategies. During GMP manufacturing campaigns, you will serve as a "person-in-plant," providing technical representation, troubleshooting, and authoring transfer documentation.
Cross-functional collaboration is essential. You will partner with Analytical Development, Quality Control, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams, presenting actionable recommendations to CMC leadership. The ideal candidate is a hands-on scientist comfortable with experimental design, root-cause problem solving, and working in GMP/plant environments under time constraints.
This is a full-time, exempt position offering bonus and equity eligibility. The role is onsite 5 days per week in Berkeley, CA. This is an excellent opportunity to join an early-stage biotech company developing next-generation cell and gene therapies while shaping the future of drug product development.
