Senior Process Engineer, MSAT (CGT)
Core
Lead technology transfer, scale-up, and process optimization for mammalian treatments and cell therapies in a GMP-compliant manufacturing environment.
Role type
Senior Process Engineer (Cell, Gene and Therapy)
Builds
Mammalian treatments and cell therapies for biotech and pharmaceutical clients
Domain
Life Sciences / Biologics Manufacturing / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development, GMP compliance, aseptic manufacturing, technology transfer, scale-up, troubleshooting, change control management, regulatory inspection support, material assessment, quality event management (CRF, NC, CAPA)
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead or support technology transfer and scale-up of manufacturing processes; Conduct lab-scale experiments and troubleshooting; Author and review technical documentation and training materials; Monitor production runs and drive process improvements; Provide on-floor support during campaigns and manage change controls; Participate in audits and regulatory inspections; Lead material assessment and continuous improvement projects; Serve as SME for materials-related investigations
Seniority
Senior, hands-on IC