Senior Process Engineer MSAT
Core
Senior Process Engineer supporting Technology Transfer and production of BMS CAR-T products for global clinical trials and commercial supply.
Role type
Senior IC process engineer (cell therapy manufacturing)
Builds
CAR-T cell therapy products for clinical trials and commercial supply
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
cGMP operations, process deviation investigation, change control management, single-use technologies, closed systems, cold chain/cryogenic technologies, clean room design, cross-functional team leadership, risk mitigation, root cause analysis, CAPA execution, technology transfer, batch record management, SOP authoring, equipment design implementation
Preferred skills
Advanced degree, MSAT experience, new facility start-up experience
Technologies
single-use technologies, closed systems, cold chain/cryogenic technologies, automation
Responsibilities
Monitor and optimize end-to-end manufacturing processes; Lead investigation of process deviations and implement changes; Author and review technical documentation (SOPs, batch records, investigations); Act as SME for technology transfer into the Leiden Cell Therapy Facility; Lead cross-functional collaboration with Manufacturing, Quality, and Engineering; Execute test plans and risk mitigation exercises for complex investigations; Support regulatory inspections.
Seniority
Senior, hands-on IC
