Senior MSAT Process Engineer, Cell & Gene Therapy

GeneFab; Alameda (CA); On-site; USD 150,000 - 185,000; Full time

Job summary

GeneFab is seeking a Senior Process Engineer, MSAT, to establish GMP-ready platform processes for cell and gene therapy at a contractual engagement with potential conversion to full-time. The role includes leading tech transfer, CMC submissions, and cross-functional collaboration across Process Development, Quality, and Regulatory teams.

The successful candidate will drive technology transfer plans, develop and implement manufacturing equipment, and ensure regulatory compliance in IND filings

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or a closely related life sciences field.
• Advanced degree (M.S. or Ph.D.) strongly preferred.
• Experience in bioprocess development, MSAT, or GMP manufacturing.
• CDMO or CMO experience highly preferred.
• Experience with cell therapy or gene therapy modalities is advantageous.

Responsibilities

• Lead GMP implementation of internal platform processes for cell and gene therapy.
• Collaborate with Process Development to evaluate platform candidates and scalable manufacturing approaches.
• Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
• Contribute to CMC regulatory submissions by authoring and reviewing CMC module 3 sections and supporting data packages.
• Apply deep CMC knowledge to align with regulatory guidance (FDA, EMA, ICH Q8/Q9/Q10/Q11/Q12).
• MSAT lead for advanced technology transfer activities, including external and inbound transfers.
• Develop and execute tech transfer plans with process descriptions, batch records, and acceptance criteria.
• Lead identification, evaluation, procurement, and implementation of GMP manufacturing equipment.
• Author, review, and approve SOPs, work instructions, batch records, and GMP-controlled documents.
• Provide technical oversight during engineering and GMP runs to ensure reproducibility and improvements.
• Function as MSAT SME across Process Development, Quality, Regulatory, and Manufacturing.
• Mentor junior MSAT engineers; develop training materials for platform processes and equipment.
• Own and support quality management records (deviations, CAPAs, change controls, SCARs).

Skills

MSAT leadership

Tech transfer

GMP manufacturing

CMC submissions

Regulatory knowledge

Cross-functional leadership

Education

Chemical Engineering

Bioprocess/Biochemical Eng

MS/PhD preferred

Job description

GeneFab is seeking a Senior Process Engineer, MSAT, to establish GMP-ready platform processes for cell and gene therapy at a contractual engagement with potential conversion to full-time. The role includes leading tech transfer, CMC submissions, and cross-functional collaboration across Process Development, Quality, and Regulatory teams.

The successful candidate will drive technology transfer plans, develop and implement manufacturing equipment, and ensure regulatory compliance in IND filings