CAR-T Production Lead: Ops, Quality & Compliance

START PEOPLE; Zwijnaarde; Sur place; EUR 60 000 - 82 000; Plein temps

Résumé du poste

START PEOPLE in Belgium is seeking a Production Supervisor to oversee the daily production of personalized cell therapy (CAR‑T) for clinical and commercial use, ensuring compliant, cGMP‑driven operations.

You will lead multiple units, coordinate with Manufacturing Operations, QA, Facilities & Engineering, Training and Planning, and provide hands‑on leadership on the shop floor to drive quality, efficiency, and continuous improvement across the production floor.

Responsabilités

• 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.

Connaissances

Leadership

cGMP knowledge

Cross-functional collaboration

Problem-solving

Description du poste

START PEOPLE in Belgium is seeking a Production Supervisor to oversee the daily production of personalized cell therapy (CAR‑T) for clinical and commercial use, ensuring compliant, cGMP‑driven operations.

You will lead multiple units, coordinate with Manufacturing Operations, QA, Facilities & Engineering, Training and Planning, and provide hands‑on leadership on the shop floor to drive quality, efficiency, and continuous improvement across the production floor.