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Our client, Legend Biotech, based in Zwijnaarde, is a global biotechnology company bringing the innovative CAR-T cell therapy to Ghent. With this, the Legend Biotech team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases.
They are currently in a phase of strong growth and are looking for motivated and dedicated team members
Production Lead
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:
- Lead and supervise operational units within the CAR-T production process, including component preparation, production support, CAR-T processing, filling & finishing, and cryopreservation.
- 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.
- Act as a domain expert for Quality and Operations in cGMP areas and play a central role during GMP inspections and external audits.
- 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.
- Coordinate quality system activities such as Change Controls, Deviations/Events, and CAPA.
- Ensure proper training for all team members and promote a culture of continuous learning.
- Drive operational excellence by initiating improvements that enhance efficiency, reduce costs, and improve quality.
Profiel
Who we are looking for:
- Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or a related field, or equivalent through experience.
- Minimum 3 years of experience in a GMP or ATMP environment, preferably in biotech or biopharma; experience with aseptic GMP production is an asset.
- Solid knowledge of cGMP regulations, cleanroom operations, and familiarity with Microsoft Office; experience with MES/EBR systems is a plus.
- Strong communication, organizational, and leadership skills with an empathetic and people-oriented management style.
- Positive, adaptable, and capable of prioritizing, multitasking, and solving problems effectively, with a strong attention to detail.
- Fluent in English (additional languages are a plus).
Aanbod
What we offer you:
- A meaningful job that directly contributes to the well-being of patients.
- Work in a supportive, innovative, and diverse team, where learning, personal development, and loyalty are encouraged.
- Collaborate with colleagues from around the world in an environment that values team spirit.
- Celebrate legendary moments with treats, fun gadgets, and enjoyable events.
- Attractive salary package including shift premiums, meal vouchers, eco vouchers, group and hospitalization insurance, double vacation pay, and end-of-year and performance bonuses.
- You will work in a system with a 4-day work, 4-day off schedule, ensuring a good balance between work and personal life.
- 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