Senior Manufacturing Associate -DownStream

Help Produce the Next Generation of Biologic Therapies

Are you passionate about biologics manufacturing, viral vector production, and downstream processing? We're looking for a Sr. Manufacturing Associate – Downstream to join a growing biopharmaceutical manufacturing team dedicated to developing and producing innovative therapies that improve patients' lives.

If you thrive in a fast‑paced GMP manufacturing environment and enjoy working with cutting‑edge technologies, this could be your next opportunity.

• Execute downstream manufacturing processes, including harvest, clarification, TFF, chromatography, filtration, and product filling
• Support daily GMP manufacturing operations and production schedules
• Troubleshoot equipment and processes in partnership with cross‑functional teams
• Perform in‑process testing, including pH, osmolality, conductivity, and filter integrity testing
• Prepare media and buffer solutions for manufacturing activities
• Maintain aseptic techniques and ensure cleanroom compliance and audit readiness
• Complete GMP documentation, batch records, SOPs, deviations, and technical reports
• Train and mentor junior manufacturing associates
• Support inventory management and continuous improvement initiatives

Bachelor of Science in Biotechnology, Biology, Chemistry, or equivalent. Preferred area of study: biochemistry or biology.

2+ years of experience in GMP manufacturing of biologics
; previous experience in downstream process is essential. Strong knowledge of GMP
, FDA
, and EMA regulations related to biologics and gene/viral therapy manufacturing.

On‑site in Costa Mesa, CA

Applicants must already be authorized to work in the U.S. (U.S. Citizens or Green Card holders only).