Process Engineer, Cell Therapy Process Development
Core
Design, execute, and support late-stage cell therapy process development, characterization, and BLA-enabling studies for autologous or allogenic therapies.
Role type
Senior IC process engineer (cell therapy unit operations)
Builds
Scalable, GMP-compliant cell therapy manufacturing processes and unit operations
Domain
Biotechnology / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy unit operations (isolation, activation, transduction, expansion, harvest, formulation, cryopreservation), GMP operations, process characterization (DOE, scale-up/down), data analysis, technical writing, problem-solving
Preferred skills
Automation platforms (CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors), JMP/statistical tools, digitalization/AI-enabled tools in bioprocess development
Technologies
JMP, CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors
Responsibilities
Design and execute process optimization and robustness studies; Drive implementation of closed-system operations and automation strategies; Plan and execute process characterization studies (DOE, multivariate studies, scale-down/up); Provide on-the-floor technical support during scale-up, engineering runs, and PPQ batches; Conduct batch record review, deviation assessment, and data trending; Apply AI-enabled tools and digital analytics to accelerate data review and process understanding
Seniority
Senior, hands-on IC
