Senior Manufacturing Science & Tech Engineer (Biopharma)
Asahi Kasei Bioprocess America, Inc.
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Benefits offered by this job
Job summary
Bionova Scientific LLC in Fremont, CA, part of the Asahi Kasei group, seeks an engineer to lead GMP manufacturing readiness and tech transfer for client projects. You will coordinate with cross-functional teams, ensure materials, equipment, and facilities readiness, and generate GMP documentation.
The role requires 5–10 years in biopharma manufacturing, hands-on GMP experience, and familiarity with single-use bioreactors, purification, and ERP/QAD.
Qualifications
- BS/MS/PhD in Engineering, Life Sciences, or related field with 3-5+ years (Engineer 1) or 5-10+ years (Sr. Engineer)
- Hands-on GMP manufacturing experience in biopharma
- Experience with tech transfer and process development
Responsibilities
- Lead GMP manufacturing readiness and tech transfer tasks for client projects
- Coordinate with cross-functional teams to ensure readiness of materials, equipment, and facilities
- Generate and maintain GMP material BOM and related documentation
- Support tech transfer using single-use equipment (bioreactor, chromatography, depth filtration, viral filtration, TFF)
- Author/review technical reports, batch records, SOPs, and deviations
Skills
Education
Tools
Job description
Bionova Scientific LLC in Fremont, CA, part of the Asahi Kasei group, seeks an engineer to lead GMP manufacturing readiness and tech transfer for client projects. You will coordinate with cross-functional teams, ensure materials, equipment, and facilities readiness, and generate GMP documentation.
The role requires 5–10 years in biopharma manufacturing, hands-on GMP experience, and familiarity with single-use bioreactors, purification, and ERP/QAD.
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