Sr. Manufacturing Associate – Downstream

BioTalent; Tustin (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

BioTalent in California seeks a Sr. Manufacturing Associate - Downstream to advance our viral vector production and downstream processing strategies.

You will execute downstream operations including harvest, clarification, TFF, chromatography, filtration and fill-finish, contribute to in-process testing, write and revise GMP documentation, and mentor junior team members in a state-of-the-art facility.

Qualifications

• BS in Biotechnology, Biology, Chemistry, Biochemistry, or related field.
• 2+ years of GMP biologics manufacturing experience.
• Downstream manufacturing experience required.
• Strong knowledge of GMP, FDA/EMA requirements, and biologics manufacturing.
• Experience with viral vector manufacturing preferred.
• Aseptic processing and cleanroom operations knowledge.
• Excellent troubleshooting, communication, documentation, and problem-solving skills.
• Upstream experience is a plus.
• Schedule: Monday-Friday, 8:00 AM-5:00 PM, with overtime, weekends and holidays as needed.

Responsibilities

• Execute downstream manufacturing processes including harvest, clarification, TFF, chromatography, filtration, and product filling.
• Perform in-process testing including pH, osmolality, conductivity, and filter integrity testing.
• Troubleshoot equipment and manufacturing processes in partnership with MSAT.
• Execute production activities in a GMP/cGMP cleanroom environment.
• Prepare buffers and media required for manufacturing.
• Support equipment setup, material preparation, and cleanroom readiness.
• Create and revise SOPs, Batch Production Records, logbooks, deviations, and other GMP documentation.
• Train and mentor junior Manufacturing Associates.
• Participate in continuous improvement initiatives.
• Maintain high standards of aseptic technique, safety, quality, and compliance.

Skills

GMPBiologicsManufacturing

Aseptic processing

Troubleshooting

Documentation

Problem-solving

Communication

Education

BS in Biotechnology/Biology/Cbiochemistry or related field

Tools

Viral vector manufacturing

MSAT collaboration

Job description

Are you an experienced biologics manufacturing professional looking to contribute to the development of life-saving therapies?

s looking for a Sr. Manufacturing Associate - Downstream to join our team and support manufacturing operations within a state-of-the-art viral vector facility.

What We're Looking For

• BS in Biotechnology, Biology, Chemistry, Biochemistry, or related field
• 2+ years of GMP biologics manufacturing experience
• Previous downstream manufacturing experience is required
• Strong knowledge of GMP, FDA/EMA requirements, and biologics manufacturing
• Experience with viral vector manufacturing is highly preferred
• Strong understanding of aseptic processing and cleanroom operations
• Excellent troubleshooting, communication, documentation, and problem-solving skills
• Previous upstream experience is a plus
• Schedule: Monday-Friday, 8:00 AM-5:00 PM, with flexibility for overtime, weekends, and holidays as needed.

What You'll Do

• Execute downstream manufacturing processes including harvest, clarification, TFF, chromatography, filtration, and product filling
• Perform in-process testing including pH, osmolality, conductivity, and filter integrity testing
• Troubleshoot equipment and manufacturing processes in partnership with MSAT
• Execute production activities in a GMP/cGMP cleanroom environment
• Prepare buffers and media required for manufacturing
• Support equipment setup, material preparation, and cleanroom readiness
• Create and revise SOPs, Batch Production Records, logbooks, deviations, and other GMP documentation
• Train and mentor junior Manufacturing Associates
• Participate in continuous improvement initiatives
• Maintain high standards of aseptic technique, safety, quality, and compliance

Be part of a team working at the forefront of biopharmaceutical manufacturing and viral vector production, while helping bring innovative therapies closer to patients.

Work Authorization:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time