Senior Upstream Manufacturing Associate | Biologics CDMO

Bionova Scientific; Fremont (CA); On-site; USD 41,000 - 62,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA seeks a Senior Manufacturing Associate – Upstream to independently execute complex upstream unit operations, mentor junior staff, and lead investigations. The role requires GMP qualification and strong documentation discipline.

The position offers full-time work in a cleanroom/manufacturing setting with cross-functional collaboration to support process development and client timelines.

Qualifications

• Bachelor's degree with 3–5 years biopharma manufacturing experience in GMP environment.
• Hands-on bioreactor operations (single-use or stainless-steel) and mammalian cell culture knowledge.
• Strong understanding of cGMP/cGDP with documentation, deviations, and change control.
• Experience authoring/controlling batch records, SOPs, and technical protocols; QMS/eBR exposure.
• Proven ability to train/mentor junior staff as SME on the floor.

Responsibilities

• Independently execute and oversee upstream unit operations, including media preparation, thaw/expansion, bioreactor operation, sampling, and harvest.
• Serve as GMP floor SME; train and evaluate staff competence on unit ops and documentation.
• Lead equipment troubleshooting, deviation investigations, root cause analysis, and CAPA implementation.

Skills

GMP experience

Cell culture knowledge

Root cause analysis

Documentation & SOPs

Education

Bachelor's degree in Life Sciences/ Biotechnology/ related

Tools

UNICORN

DeltaV

PI Historian

Job description

Bionova Scientific LLC in Fremont, CA seeks a Senior Manufacturing Associate – Upstream to independently execute complex upstream unit operations, mentor junior staff, and lead investigations. The role requires GMP qualification and strong documentation discipline.

The position offers full-time work in a cleanroom/manufacturing setting with cross-functional collaboration to support process development and client timelines.