Manager, Process Engineer
Core
Managing process engineering activities for 24/7 production of CAR-T cell therapy products for clinical trials and commercial supply at the Leiden facility.
Role type
Manager, Process Engineering (Cell Therapy Manufacturing)
Builds
CAR-T cell therapy products for clinical trials and commercial supply
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, cell therapy process knowledge, clean room design, single-use technologies, closed systems, cold chain/cryogenic technologies, cross-functional team leadership, process troubleshooting, change controls, root cause analysis, Lean Manufacturing, project management, regulatory inspection preparation
Preferred skills
Advanced degree, experience with external parties, strategic thinking
Technologies
MES/Automation, single-use technologies, closed systems, cryogenic technologies
Responsibilities
Drive end-to-end process monitoring, analysis, and optimization; Provide technical input for high-criticality deviations and investigations; Ensure timely review and approval of technical documentation; Provide on-site and on-call support during operations; Guide implementation of change and process improvement initiatives; Coordinate risk mitigation for manufacturing operations; Manage project teams and technical projects; Lead OOS investigations and act as Process Technical SME; Support transition from technology transfer to commercial routine manufacturing
Seniority
Manager, hands-on IC with team management
