Senior Downstream Manufacturing Associate - Biologics

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

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