Functieomschrijving
As a CAR-T Production Supervisor, you will be responsible for the daily production of personalized cell therapies for both clinical and commercial use in a sterile cGMP environment. You will coordinate various units within the CAR-T process and ensure safe, compliant operations according to cGMP requirements.
If you don't have prior formal team lead experience, that is also okay. If you have solid GMP/ATMP experience (ideally in production or close to production) and you naturally take ownership, coordinate smoothly, and feel comfortable guiding others, we strongly encourage you to apply.
Responsibilities:
1. Coordinate and supervise operational units within the CAR-T manufacturing process, including component preparation, production support, CAR-T processing, filling & finishing, and cryopreservation.
2. Act as the first point of contact for production issues and collaborate closely with Manufacturing Operations, QC IPC, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, and Supply Chain.
3. Serve as a domain expert for Quality and Operations in cGMP environments and play a key role during GMP inspections and external audits.
4. Manage all quality-related production aspects, including procedures, work instructions, logbooks, transfer forms, batch record review and release, and overall cGMP compliance.
5. Coordinate quality system activities such as Change Controls, Deviations/Events, and CAPA.
6. Ensure proper training of team members and promote a culture of continuous learning.
7. Drive operational excellence by initiating improvements that increase efficiency, reduce costs, and enhance overall quality.
Profiel
Who we are looking for:
8. Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or a related field, or equivalent through experience.
9. Minimum 3 years of experience in a GMP or ATMP environment, preferably in biotech or biopharma.
10. Experience in people management, or with relatable coordinating activities such as training, coaching, ... .
11. Solid knowledge of cGMP regulations and cleanroom operations; familiarity with Microsoft Office is required, and experience with MES/EBR is a plus.
12. Strong communication and organizational skills. You don’t need formal leadership experience, but you do show natural leadership qualities:
13. you take ownership
14. you guide and support others confidently
15. you keep oversight and work in a structured way
16. Positive, adaptable, and capable of prioritizing, multitasking, and solving problems effectively, with strong attention to detail.
17. Fluent in English; additional languages are a plus.
Aanbod
What we offer you:
18. A meaningful job that directly contributes to the well-being of patients.
19. Work in a supportive, innovative, and diverse team, where learning, personal development, and loyalty are encouraged.
20. Attractive salary package including 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 weekend 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.
23. Collaborate with colleagues from around the world in an environment that values team spirit.
24. Celebrate legendary moments with treats, fun gadgets, or enjoyable events.