Senior Upstream Biotech Manufacturing Associate (GMP)

Bionova Scientific LLC; United States; On-site; USD 41,000 - 62,000; Full time

Job summary

Bionova Scientific LLC in Fremont, California, is seeking a Senior Manufacturing Associate – Upstream. This role independently executes complex upstream unit operations, serves as a SME and trainer, and supports day-to-day floor operations with minimal supervision.

Candidates will troubleshoot, investigate deviations, author GMP documentation, and participate in continuous improvement initiatives to enhance cell culture capacity and efficiency.

Qualifications

• Bachelor's degree in Life Sciences or related field with 3–5 years biopharma manufacturing experience.
• GMP environment experience with upstream bioreactor operations (seed train, production bioreactors).
• Strong knowledge of cGMP/cGDP in manufacturing documentation and audits.

Responsibilities

• Independently executes complex upstream unit operations and oversees media/solution prep, bioreactor operation, sampling, and harvest.
• Trains, mentors, and evaluates junior staff; serves as SME on the manufacturing floor.
• Leads troubleshooting, deviation investigations, root cause analysis, and CAPA implementation.

Skills

GMP knowledge

Troubleshooting

Mentoring/SME

Documentation

Education

Bachelor's degree in Life Sciences

Associate's degree in related field

Tools

UNICORN

PI Historian

DeltaV

eBR

QMS platforms

Job description

Bionova Scientific LLC in Fremont, California, is seeking a Senior Manufacturing Associate – Upstream. This role independently executes complex upstream unit operations, serves as a SME and trainer, and supports day-to-day floor operations with minimal supervision.

Candidates will troubleshoot, investigate deviations, author GMP documentation, and participate in continuous improvement initiatives to enhance cell culture capacity and efficiency.