MSAT Process Engineer II/III — Cell Therapy & Viral Vector

GeneFab

Alameda (CA)

On-site

USD 100,000 - 130,000

Full time

5 days ago
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Job summary

GeneFab in Alameda, CA is seeking a Process Engineer II/III, MSAT to support technology transfer, GMP manufacturing, and program readiness for cell and gene therapies. This individual contributor roles acts as technical owner for processes moving from development to GMP production across autologous and allogeneic programs.

The role collaborates with Manufacturing, PD, Analytical Development, QA, QC, Supply Chain and client teams to ensure GMP readiness, robust batch execution, and scalable

Qualifications

  • Degrees in chemical or life sciences as listed in the qualifications.
  • Experience in technology transfer and manufacturing support in cGMP environments.
  • Hands-on experience with cell therapy and viral vector manufacturing.

Responsibilities

  • Lead or support technology transfer workstreams and develop transfer plans.
  • Provide MSAT process ownership for autologous/allogeneic therapies and viral vectors.
  • Provide on-the-floor GMP manufacturing support, troubleshoot issues, and investigate deviations.
  • Support PPQ planning, CPV programs, and continuous improvement initiatives.
  • Develop and review batch records, SOPs, and GMP documentation.

Skills

Process Engineering
cGMP
Technology Transfer
Data Analysis
Documentation
Project Management
Communication

Education

Bachelor’s or Master’s in Chemical Engineering, Bioengineering, Biomedical Engineering, Biotechnology, Cell/Molecular Biology, or related field

Tools

JMP
Minitab

Job description

GeneFab in Alameda, CA is seeking a Process Engineer II/III, MSAT to support technology transfer, GMP manufacturing, and program readiness for cell and gene therapies. This individual contributor roles acts as technical owner for processes moving from development to GMP production across autologous and allogeneic programs.

The role collaborates with Manufacturing, PD, Analytical Development, QA, QC, Supply Chain and client teams to ensure GMP readiness, robust batch execution, and scalable

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