Functieomschrijving
As a CAR-T Production Lead, you are responsible for the daily production process of personalized cell therapy, both for clinical and commercial purposes, in a sterile cGMP environment. You will lead various units within the CAR-T process and ensure safe and compliant production activities according to cGMP requirements.
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. Serve 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. Act as a domain expert for Quality and Operations in cGMP areas and play a central role during GMP inspections and external audits.
4. Manage all quality-related aspects of production, including documentation (procedures, work instructions, logs, transfer forms), batch record review and release, and adherence to cGMP standards.
5. Coordinate quality system activities such as Change Controls, Deviations/Events, and CAPA.
6. Ensure proper training for all team members and promote a culture of continuous learning.
7. Drive operational excellence by initiating improvements that enhance efficiency, reduce costs, and improve 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; experience with aseptic GMP production is an asset.
10. Solid knowledge of cGMP regulations, cleanroom operations, and familiarity with Microsoft Office; experience with MES/EBR systems is a plus.
11. Strong communication, organizational, and leadership skills with an empathetic and people-oriented management style.
12. Positive, adaptable, and capable of prioritizing, multitasking, and solving problems effectively, with a strong attention to detail.
13. Fluent in English (additional languages are a plus).
Aanbod
What we offer you:
14. A meaningful job that directly contributes to the well-being of patients.
15. Work in a supportive, innovative, and diverse team, where learning, personal development, and loyalty are encouraged.
16. Collaborate with colleagues from around the world in an environment that values team spirit.
17. Celebrate legendary moments with treats, fun gadgets, and enjoyable events.
18. Attractive salary package including shift premiums, meal vouchers, eco vouchers, group and hospitalization insurance, double vacation pay, and end-of-year and performance bonuses.
19. You will work in a system with a 4-day work, 4-day off schedule, ensuring a good balance between work and personal life.
20. 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