MSAT Engineer | Biologics Tech Transfer Leader

AK America

Fremont (CA)

On-site

USD 62,000 - 90,000

Full time

3 days ago

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Job summary

Bionova Scientific LLC in Fremont, CA is seeking an Engineer I/Sr. Engineer in Manufacturing Science and Technology to support GMP manufacturing readiness and tech transfer across upstream cell culture and/or downstream purification projects.

The role is based in Fremont and requires 3–10 years of relevant experience depending on level. As part of the MSAT group, you will coordinate with cross-functional teams, author documents, train staff, and ensure compliance with cGMP and cGDP while

Qualifications

BS, MS, or PhD in Engineering or Life Sciences with 3–5 years (Engineer I) or 5–10 years (Sr. Engineer) in biopharma.
Hands-on GMP manufacturing with upstream or downstream equipment.
Experience with process development, tech transfer, and process characterization.
Working knowledge of cGMP compliance and related documentation.
Experience with process monitoring software and ERP systems (QAD).
Strong communication, organization, and ability to manage multiple projects.

Responsibilities

Coordinate GMP manufacturing readiness and tech transfer for new products.
Generate and maintain GMP material BOMs using ERP systems.
Ensure facility readiness; collaborate with process development, vendors, and clients.
Support tech transfer using single-use equipment (bioreactor, chromatography, filtration).
Assist with deviations, CAPAs, and change controls.
Author and review technical docs, batch records, and SOPs.
Lead internal meetings and communicate with stakeholders.
Maintain training records and ensure compliance with cGMP/cGDP.