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:
1. Lead and supervise operational units within the CAR-T production process, including component preparation, production support, CAR-T processing, filling & finishing, and cryopreservation.
2. 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.
3. Provide hands-on leadership on the shop floor, supporting teams in daily operations, troubleshooting, and decision-making in cGMP environments.
4. Serve as a subject matter expert for Quality and Operations and play a key role during GMP inspections and external audits.
5. Oversee production quality activities, including documentation management (procedures, work instructions, logs, transfer forms), batch record review and release, and compliance with cGMP standards.
6. Coordinate quality system processes such as Change Controls, Deviations/Events, and CAPA.
7. Guide and support team development through structured training and operational coaching.
8. Drive operational excellence by leading process improvements focused on efficiency, cost reduction, and quality enhancement.
Profiel
Who we are looking for:
9. Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or a related field, or equivalent through experience.
10. Minimum 3 years of experience in a production environment, preferably in biotech or biopharma.
11. Strong experience in management, for example as a production lead, supervisor, or similar leadership role.
12. Solid knowledge of cGMP regulations, cleanroom operations, and familiarity with Microsoft Office; experience with MES/EBR systems is a plus.
13. Strong communication, organizational, and leadership skills with an empathetic and people-oriented management style.
14. Positive, flexible, and capable of prioritizing, multitasking, and solving problems effectively, with a strong attention to detail.
15. Fluent in English (additional languages are a plus).
Aanbod
What we offer you:
16. A meaningful job that directly contributes to the well-being of patients.
17. Work in a supportive, innovative, and diverse team, where learning, personal development, and loyalty are encouraged.
18. Collaborate with colleagues from around the world in an environment that values team spirit.
19. Celebrate legendary moments with treats, fun gadgets, and enjoyable events.
20. Attractive salary package including shift premiums, meal vouchers, eco vouchers, group and hospitalization insurance, double vacation pay, and end-of-year and performance bonuses.
21. You will work in a system with a 4-day work, 4-day off schedule, ensuring a good balance between work and personal life.
22. Since we cannot predict exactly where you'll be in the process, you must be comfortable working across all eight of these shifts: 6 AM to 4 PM, 7 AM to 5 PM, 8 AM to 6 PM, 10 AM to 8 PM, 12 PM to 10 PM, 2 PM to 12 AM, 3PM to 1 AM, and 4 PM to 2 AM & future night shift.