CAR-T Operations Expert at Legend Biotech

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.  

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. 

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.    

✔ A meaningful job with an excellent work-life balance. You will work 4 days. After that you will 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. 
 

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.  

Legend Biotech was founded in 2014 and now employs over 2,400 people across six global manufacturing facilities. Two of these are located in Ghent: Obelisc (Technologie Park, Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde). Our headquarters are based in Somerset, New Jersey (USA).

In Ghent, we specialize in the production of advanced CAR-T therapies for the treatment of multiple myeloma, in collaboration with Johnson & Johnson.  

1. You answer a few short questions.
2. You upload your resume or email it later.
3. You will receive a confirmation of your application.
4. Hannelore from Legend Biotech will contact you.