Process Engineer, Cell Therapy Process Development
Core
Process Engineer supporting late-stage cell therapy process development, characterization, and BLA-enabling studies for unit operations including T-cell enrichment, activation, transduction, washes, and harvest.
Role type
Senior IC process engineer (cell therapy)
Builds
Scalable, GMP-compliant cell therapy manufacturing processes and unit operations
Domain
Biotechnology / Cell Therapy
Deliverable
production ML models
Required skills
Cell therapy unit operations, GMP operations, Process development and characterization, DOE and multivariate studies, Data analysis, Technical reporting, AI-enabled tools, Batch record review, Deviation assessment
Preferred skills
Automation platforms (CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors), Closed/automated systems, JMP statistical tools, Digitalization/AI application
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; Plan and execute process characterization studies (DOE, scale-down/up); Provide on-the-floor technical support during scale-up and PPQ batches; Conduct batch record review and deviation assessment; Apply AI tools for data analysis and workflow automation.
Seniority
Mid-Senior, hands-on IC