CAR-T Operations Expert

Legend Biotech is an innovative biotechnology company that develops and commercializes life-saving cell therapies. 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!   

What can you expect? 

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. 

Who are we looking for? 

  Education:  

• 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. 

  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.  

Languages:  

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

Strengths 

• 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.    

Expertise: 

• 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.     

What do we offer?    

• A meaningful job that contributes directly to the well-being of patients. 
• An excellent work-life balance. You work 4 days. Then you enjoy 4 days off.
• A supportive and innovative work environment. We value and encourage learning and personal development. 
• The opportunity to work with people from all over the world.
• A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
• Many fun and informal events. 

About Legend Biotech    

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for intractable diseases such as cancer.  

Since our founding in 2014 in Somerset, New Jersey, we have grown into a company with more than 2,000 employees in six manufacturing facilities worldwide.  

In Ghent, we are focusing on the production of our advanced CAR-T therapy for the treatment of multiple myeloma, in collaboration with Johnson & Johnson.