Senior Scientist. Cell Therapy Process Development
Core
Lead CAR-T cell therapy process development, focusing on autologous manufacturing processes from preclinical to clinical stages.
Role type
Senior Scientist (Cell Therapy Process Development)
Builds
Robust, scalable, and transferable autologous CAR-T manufacturing processes and workflows.
Domain
Biotechnology / Cell Therapy / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing process development)
Required skills
Mammalian cell culture, aseptic processing, experimental design, flow cytometry, cell processing equipment operation, process scale-up, technology transfer, statistical analysis
Preferred skills
Autologous CAR-T process development, closed-system processing platforms, multicolor flow cytometry, T-cell biology, GMP manufacturing support, automation/digital monitoring
Technologies
CliniMACS Prodigy, Sepax/Sefia, LOVO/CUE, DynaCellect, G-Rex, flow cytometry instruments, statistical software
Responsibilities
Design and execute laboratory studies for cell selection, activation, gene modification, expansion, harvest, formulation, and cryopreservation; Develop and optimize unit operations using quality-by-design principles; Evaluate and implement cell therapy processing equipment; Define critical process parameters and troubleshoot platforms; Apply flow cytometry for cell characterization; Perform statistical and multivariate data analysis; Support technology transfer to GMP sites; Author technical documents and regulatory content; Mentor junior scientists
Seniority
Senior, hands-on IC with leadership responsibilities
