Production Team Lead

Description de fonction

As a Production Team Lead, 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 the different units within the CAR-T process and ensure that all activities are carried out safely and in full compliance with cGMP requirements — while steering and organizing the operations from your office-based workspace, keeping a strong overview of the production flow and acting as the central point of coordination for the team. If you don't have prior leadership experience yet, that is also okay. 

What you can expect: 

• Coordinate and supervise operational units within the CAR-T manufacturing process, including component preparation, production support, CAR-T processing, filling & finishing, and cryopreservation.
• 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.
• Serve as a domain expert for Quality and Operations in cGMP environments and play a key role during GMP inspections and external audits.
• Manage all quality-related production aspects, including procedures, work instructions, logbooks, transfer forms, batch record review and release, and overall cGMP compliance.
• Coordinate quality system activities such as Change Controls, Deviations/Events, and CAPA.
• Ensure proper training of team members and promote a culture of continuous learning.
• Drive operational excellence by initiating improvements that increase efficiency, reduce costs, and enhance overall quality.

Information

Our client, Legend Biotech, based in Zwijnaarde, is a global biotechnology Information 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

Profil

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 environment, preferably in biotech or biopharma. 
• Experience in people management , or with relatable coordinating activities such as training, coaching, ... .
• Solid knowledge of cGMP regulations and cleanroom operations; familiarity with Microsoft Office is required, and experience with MES/EBR is a plus.
• Strong communication and organizational skills. You don’t need formal leadership experience, but you do show natural leadership qualities.
• Positive, flexible, and capable of prioritizing, multitasking, and solving problems effectively, with strong attention to detail.
• Fluent in English; additional languages are a plus.

Offre

What we Offre 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, group and hospitalization insurance, double vacation pay, and end-of-year and performance bonuses.
• A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off. This position operates within our future (rotating) night shift system.
• Please be prepared to work across various shifts starting from 6AM and ending by 2AM as well as our night shifts ranging from 6PM until 4 AM and 8 PM until 6AM. While night shifts are not currently in place, employees hired for this role should be willing and able to work within the (rotating) night shift system once implemented.
• Collaborate with colleagues from around the world in an environment that values team spirit.
• A strong team culture with memorable events, celebrations, and plenty of legendary moments.