Senior MSAT Process Engineer - Cell & Gene Therapy GMP

GeneFab; Alameda (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

GeneFab is seeking a highly motivated Senior Process Engineer, MSAT to serve as a technical authority within our Cell and Gene Therapy CDMO. This role drives GMP-ready platform processes and cross-functional initiatives spanning process development, technology transfer, and CMC strategy.

The contract engagement offers potential conversion to full-time based on performance. You will lead MSAT activities, author regulatory-support documents, and help build scalable GMP manufacturing capabilities

Qualifications

• 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 technical lead for technology transfer, validation, and lifecycle management.
• Contribute to CMC regulatory submissions by authoring and reviewing CMC sections, development summaries, and data packages.
• Apply deep CMC knowledge to ensure alignment with regulatory guidance (FDA, EMA, ICH).
• Lead MSAT for advanced technology transfer activities and inbound transfers.
• Develop and execute comprehensive tech transfer plans including process descriptions and batch records.
• Identify, evaluate, procure, and implement GMP manufacturing equipment for platform capabilities.
• Author, review, and approve SOPs and GMP-controlled documents.
• Provide technical oversight during manufacturing runs to evaluate reproducibility and drive improvements.
• Function as MSAT SME across PD, QA, Regulatory and Manufacturing.
• Provide mentorship and training materials for platform processes and equipment.
• Own and support quality management records (deviations, CAPAs, change controls).

Responsibilities

• Lead GMP implementation of platform processes for cell and gene therapies.
• Collaborate with PD to select scalable platform candidates and align on CMC requirements.
• Act as MSAT lead for tech transfer, validation, and lifecycle management.
• Support regulatory submissions by preparing CMC sections and data packages.
• Ensure GMP processes comply with current regulatory guidance.
• Oversee advanced tech transfer activities including external client transfers.
• Develop tech transfer plans with process descriptions and batch records.
• Source and implement GMP equipment to enable platform capabilities.
• Draft and approve SOPs and GMP documents.
• Monitor manufacturing runs to ensure reproducibility and process control.
• Serve as MSAT SME across cross-functional teams.
• Mentor junior MSAT engineers and deliver training material.
• Manage deviations, CAPAs, and change controls.

Skills

GMP implementation

Tech transfer

CMC regulatory

Cross-functional leadership

Design of Experiments

Bioprocess development

GMP documentation

IND submissions

Education

Bachelor's degree in Chemical Engineering or related life sciences

MS or PhD preferred

Job description

GeneFab is seeking a highly motivated Senior Process Engineer, MSAT to serve as a technical authority within our Cell and Gene Therapy CDMO. This role drives GMP-ready platform processes and cross-functional initiatives spanning process development, technology transfer, and CMC strategy.

The contract engagement offers potential conversion to full-time based on performance. You will lead MSAT activities, author regulatory-support documents, and help build scalable GMP manufacturing capabilities