GMP Biologics Manufacturing Associate

Bionova Scientific LLC; Fremont (CA); On-site; USD 34,000 - 41,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA, is seeking a Manufacturing Associate to contribute to GMP manufacturing and technology transfer projects. You will join the Purification/Manufacturing group and work on a broad range of projects including troubleshooting, process transfers into the GMP facility, and hands‑on execution of complex experiments in a collaborative team.

The role requires performing unit operations such as chromatography, depth filtration, virus filtration, and buffer

Qualifications

• Associate degree with 1-2 years of relevant experience or equivalent.
• Working knowledge of cGMP as it applies to procedures and manufacturing.
• Familiar with purification processes (affinity, IEX, SEC) and downstream steps.

Responsibilities

• Execute complex unit operations in GMP suites (chromatography, TFF, filtration).
• Maintain training compliance and support equipment troubleshooting.
• Author/Review tech transfer protocols, batch records, SOPs and reports.
• Document work per cGMP and cGDP; uphold cleanroom standards.
• Support investigations, deviations, CAPA, and change control.

Skills

cGMP knowledge

Independent work

Cross-functional teamwork

Creative problem solving

Education

Associate degree

Biopharma field preferred

Tools

UNICON? Not

Job description

Bionova Scientific LLC in Fremont, CA, is seeking a Manufacturing Associate to contribute to GMP manufacturing and technology transfer projects. You will join the Purification/Manufacturing group and work on a broad range of projects including troubleshooting, process transfers into the GMP facility, and hands‑on execution of complex experiments in a collaborative team.

The role requires performing unit operations such as chromatography, depth filtration, virus filtration, and buffer