Functieomschrijving

As a Production Supervisor, you are responsible for the daily production process of personalized cell therapy, both for clinical and commercial purposes. You will lead various units within the CAR-T process and ensure safe and compliant production activities in accordance with cGMP requirements — all while coordinating and overseeing operations from your dedicated office workspace, maintaining a clear overview of the production floor and ensuring smooth cross-team collaboration.

Tasks:

• Lead and supervise operational units within the CAR-T production process, including component preparation, production support, CAR-T processing, filling & finishing, and cryopreservation.
• Act as the primary point of contact for production-related topics, ensuring smooth coordination with Manufacturing Operations, QC IPC, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, and Supply Chain.
• Provide hands-on leadership on the shop floor, supporting teams in daily operations, troubleshooting, and decision-making in cGMP environments.
• Serve as a subject matter expert for Quality and Operations and play a key role during GMP inspections and external audits.
• Oversee production quality activities, including documentation management (procedures, work instructions, logs, transfer forms), batch record review and release, and compliance with cGMP standards.
• Coordinate quality system processes such as Change Controls, Deviations/Events, and CAPA.
• Guide and support team development through structured training and operational coaching.
• Drive operational excellence by leading process improvements focused on efficiency, cost reduction, and quality enhancement.