Senior Manufacturing Associate -DownStream

BioTalent; Costa Mesa (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

BioTalent in Costa Mesa, CA, is seeking a Sr. Manufacturing Associate – Downstream to help advance biologics manufacturing.

You will perform downstream unit operations, support GMP operations, and mentor junior staff in a fast-paced biopharmaceutical environment. Responsibilities include executing harvest, clarification, TFF, chromatography, filtration, and filling; troubleshooting equipment and processes with cross-functional teams; conducting in-process testing; and preparing media and

Qualifications

• Bachelor of Science in Biotechnology, Biology, Chemistry, or equivalent.
• 2+ years of experience in GMP manufacturing of biologics; downstream process experience essential.
• Strong knowledge of GMP, FDA, and EMA regulations related to biologics and gene/viral therapy manufacturing.

Responsibilities

• Execute downstream manufacturing processes: harvest, clarification, TFF, chromatography, filtration, and filling.
• Support daily GMP manufacturing operations and production schedules.
• Troubleshoot equipment and processes with cross-functional teams.
• Perform in-process testing (pH, osmolality, conductivity, filter integrity).
• Prepare media and buffers for manufacturing activities.
• Maintain aseptic techniques and cleanroom compliance.

Skills

Downstream manufacturing

GMP manufacturing

Aseptic technique

Documentation

Mentoring/Training

Troubleshooting

Education

BS in Biotechnology/Biology/Chemistry

Job description

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.

What You’ll Do

• 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

What We’re Looking For

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.

Location

On‑site in Costa Mesa, CA

EEO Statement

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