Laboratory Operations Expert

The company is a global biotechnology firm dedicated to treating, and one day curing, life-threatening diseases. They are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From their three R&D sites around the world, they apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.For the branch in Zwijnaarde the company is looking for new Laboratory Operations Experts to participate with their research.

This are the tasks of a Lab Operations Expert:

• 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.

This is the profile of a Lab Operations Expert:

• 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.

Page Personnel Belgium
Mathias Verdickt
Toon nummer+3225094573
Bastion Tower
Marsveldplein 5
Place du Champ de Mars 5
1050 Brussels