CAR-T Operations Expert

We are looking for a passionate CAR-T Operations Expert to join our team in Ghent. Ready to make a difference in patients' lives and lead innovative CAR-T cell therapy projects? Let us hear from you. We'd love to meet you!   

As a CAR-T Operations Expert, you will be a specialist in specific parts of the CAR-T production process. Here's what you'll do: 

• Perform and oversee CAR-T process activities: You will participate in and oversee specific parts of the CAR-T manufacturing process such as component preparation, CAR-T processing, filling and finishing, and cryopreservation.
• Compliance and documentation: You ensure that all activities comply with cGMP and GDP standards. You will develop and maintain GMP documents to ensure compliance and traceability.
• Operational support: You manage daily production planning and support production surveys. You will create and review operational procedures, including work instructions, master batch records and forms.
• Collaborate and continuously improve: You will work with various teams to streamline and optimize processes. You will also participate in Lean & Operational Excellence projects. 
• Training: You will train and coach junior colleagues. 
• Technology and Systems: You will support the testing and implementation of various software for production output systems such as eLiMS, MES and SAP. 

• You have a bachelor's or master's degree in sciences, (bio)engineering, biotechnology, pharmacy or a related field of study or you are equivalent through experience. 

• You have at least 3 years of operational experience within a cGMP or ATMP environment and with aseptic techniques in clean rooms, preferably in the biotech or pharmaceutical industry. Previous experience in manufacturing, quality or engineering is required.  

• You are fluent in Dutch or English, with strong oral and written communication skills.  

• You are a true team player with strong relational, analytical and problem-solving skills. You are detail-oriented and strive for excellence. You are also motivated and enthusiastic, but it is your "can-do" mentality that typifies you the most.   

• You have a thorough knowledge of cGMP regulations and cell culture techniques.
• You can work fluently with Microsoft Office tools such as Word, Excel, PowerPoint and Outlook.
• Experience with cGMP systems such as PASx, eLIMs, Siemens and SAP are a nice plus.     

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer. The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde). In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.

#LI-AG1