Senior Upstream Manufacturing Lead

Bionova Scientific, Inc.; Fremont, Northern (CA, KY); Hybrid; USD 41,000 - 62,000; Full time

Job summary

Bionova Scientific, Inc. in Fremont, CA is seeking a Senior Manufacturing Associate – Upstream to independently execute complex upstream unit operations, mentor staff, and drive continuous improvement in a GMP biotech environment.

The role requires hands-on experience with mammalian cell culture, bioreactor operations (single-use and stainless steel), process monitoring, deviations, CAPAs, and documentation such as batch records and SOPs; strong problem-solving and cross-functional collaboration

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Chemical/Biochemical Engineering, or related field with 3–5 years of biopharma manufacturing experience; OR Associate's degree with 5+ years of relevant experience.
• Hands-on experience with single-use and stainless-steel bioreactor operations in a GMP environment.
• Strong knowledge of mammalian cell culture, upstream processes, and troubleshooting.
• Experience authoring batch records, SOPs, and technical protocols in regulated environments.

Responsibilities

• Independently executes complex upstream unit operations, including media preparation and cell culture expansion.
• Trains and mentors manufacturing associates on operations and documentation practices.
• Lead troubleshooting, deviations, root cause analysis, and CAPA implementations on floor.
• Author and review GMP documents such as batch records and SOPs.
• Support pilot-scale campaigns and process development to meet timelines.
• Contribute to continuous improvement and Lean initiatives.

Skills

Upstream unit operations

GMP

Training/Mentoring

Troubleshooting

Process monitoring

Education

Bachelor's degree in Life Sciences or related field

Associate's degree with 5+ years experience

Tools

UNICORN

PI Historian

DeltaV

Electronic Batch Records (eBR) systems

Job description

Bionova Scientific, Inc. in Fremont, CA is seeking a Senior Manufacturing Associate – Upstream to independently execute complex upstream unit operations, mentor staff, and drive continuous improvement in a GMP biotech environment.

The role requires hands-on experience with mammalian cell culture, bioreactor operations (single-use and stainless steel), process monitoring, deviations, CAPAs, and documentation such as batch records and SOPs; strong problem-solving and cross-functional collaboration