Pharma

Pharma

Production Lead

9052 ZWIJNAARDE
Vast contract
Master
35 u/week
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Functieomschrijving

As a CAR-T Production Supervisor, 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.
  • Attractive salary package including 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.
  • Collaborate with colleagues from around the world in an environment that values team spirit.
  • Participate in many fun and informal events.

Bedrijfsinfo

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

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Start People Inhouse Legend Biotech
+32 (0)93 377 999
legendbiotech@startpeople.be
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