Senior MSAT Downstream Engineer, Viral Vectors - Onsite

Azalea Therapeutics; Berkeley (CA); On-site; USD 170,000 - 215,000; Full time

Benefits offered by this job

Equity eligible

Bonus eligible

Job summary

Azalea Therapeutics in Berkeley, CA is seeking a Principal Engineer I/II, MSAT - Viral Vector Downstream to lead external downstream process transfer and manufacturing readiness for EDV and AAV programs. This senior individual-contributor role partners with PD and QA, mentoring staff and guiding CDMOs toward GMP readiness.

You will own process transfer plans, establish control strategies, and balance speed, quality, and regulatory expectations while traveling to CDMOs as needed.

Qualifications

• Minimum Qualifications: degree in chemical/biochemical/bioengineering or related field with 12+ years (or Master’s 10+ years, PhD 8+ years).
• Experience in downstream processing for viral vectors, gene therapies, or complex biologics.
• Demonstrated success in technology transfer to external manufacturers and GMP manufacturing.
• Strong analytical and troubleshooting capability; ability to communicate risks clearly to cross-functional teams.

Responsibilities

• Define and lead external downstream process strategy for viral vector programs (EDV/AAV).
• Lead technology transfer to CDMOs, including plans, protocols, batch records, and transfer criteria.
• Provide technical leadership for pilot, engineering, and GMP manufacturing runs; review data and troubleshoot.
• Mentor contributors and influence cross-functional decisions with limited oversight.

Skills

Downstream processing

MSAT

Viral vectors

GMP manufacturing

Education

Bachelor's degree in chemical/biochemical/bioengineering

Master's degree in related field

PhD in related field

Job description

Azalea Therapeutics in Berkeley, CA is seeking a Principal Engineer I/II, MSAT - Viral Vector Downstream to lead external downstream process transfer and manufacturing readiness for EDV and AAV programs. This senior individual-contributor role partners with PD and QA, mentoring staff and guiding CDMOs toward GMP readiness.

You will own process transfer plans, establish control strategies, and balance speed, quality, and regulatory expectations while traveling to CDMOs as needed.