Sr. Manufacturing Associate – Downstream
Job in
Tustin, Orange County, California, 92681, USA
Listed on 2026-09-21
Listing for:
BioTalent
Per diem
position Listed on 2026-09-21
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Manufacturing & Industrial Operations, Validation Engineer
Job Description & How to Apply Below
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
.
- 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.
- 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
Position Requirements
10+ Years
work experience
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