MSAT Engineer | Biopharma Tech Transfer & GMP Expert

Asahi Kasei Bioprocess America, Inc.; United States; On-site; USD 62,000 - 90,000; Full time

Job summary

Asahi Kasei Bioprocess America, Inc. is seeking an Engineer I/Sr.

Engineer in Manufacturing Science and Technology (MSAT) to contribute to manufacturing and technology transfer projects at the Bionova Scientific West Warren Fremont location. The role focuses on Upstream (US) Cell Culture and/or Downstream (DS) Purification, coordinating GMP readiness, tech transfer, and client project support in Fremont, California.

Qualifications

• Hands-on GMP manufacturing experience in biopharma.
• Experience with Upstream (cell culture) or Downstream (purification) processes.
• Working knowledge of cGMP compliance and documentation.
• Experience with process development, tech transfer, and deviations/CAPAs.

Responsibilities

• Coordinate GMP manufacturing readiness and tech transfer for NPI projects.
• Generate and maintain GMP BOM using ERP system (QAD).
• Ensure facility readiness and collaborate with process development, vendors, and clients.
• Support tech transfer using single-use equipment (bioreactor, chromatography, filtration).
• Author/review technical docs: reports, plans, batch records, SOPs.
• Lead internal meetings and communicate with stakeholders.

Skills

Creative thinker

Ability to work independently

Organize and communicate effectively

Prioritize assignments and manage múlt

Education

BS, MS, or PhD in Engineering, Life Sciences, or related discipline

Tools

UNICON

Pi Historian

QAD ERP

Job description

Asahi Kasei Bioprocess America, Inc. is seeking an Engineer I/Sr.

Engineer in Manufacturing Science and Technology (MSAT) to contribute to manufacturing and technology transfer projects at the Bionova Scientific West Warren Fremont location. The role focuses on Upstream (US) Cell Culture and/or Downstream (DS) Purification, coordinating GMP readiness, tech transfer, and client project support in Fremont, California.