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Azalea Therapeutics is seeking a Principal Engineer I/II for Manufacturing Science and Technology (MSAT) focused on viral vector downstream processing. This senior individual-contributor role reports to the VP of External CMC Operations and serves as the technical lead for downstream viral vector technology transfer and manufacturing readiness.
The role is accountable for the technical direction of a major manufacturing area, advancing EDV (Enveloped Delivery Vehicles) and AAV manufacturing capabilities to support pipeline programs toward first-in-human readiness. Key responsibilities include defining and leading external downstream process strategy, collaborating with process development teams on clarification, filtration, chromatography, ultrafiltration/diafiltration, formulation, and sterile filtration. The engineer will establish phase-appropriate process understanding and control strategies, identifying critical quality attributes, critical process parameters, and key material attributes.
The incumbent will own technology transfer to contract development and manufacturing organizations (CDMOs), including transfer plans, process descriptions, protocols, batch records, training, and readiness assessments. They will provide technical leadership for pilot, engineering, and GMP manufacturing runs, reviewing data in real time, identifying trends, troubleshooting complex issues, and driving decisions. The role includes leading investigations of process deviations, manufacturing failures, and recurring issues, developing root-cause hypotheses and corrective action plans in partnership with Quality and external manufacturing partners.
This is a hands-on position requiring deep downstream process expertise, comfort with data analysis and CMC strategy, and the ability to lead through influence in a lean, externally networked organization. The candidate will work closely with internal teams, mentor contributors, and influence cross-functional decisions with limited oversight. Full-time onsite at Berkeley headquarters with travel to CDMOs during manufacturing runs. The role offers equity and bonus eligibility.
