We are seeking Manufacturing Specialists to provide operational expertise to our decentralized manufacturing units for CAR-T cell therapies in Antwerp and Liege. Your ability to communicate at native/advanced level in French is crucial. The candidate will have a critical role in technical support through clinical manufacturing and technology transfers, act as SME in aseptic training, facilitate production training and take ownership of material management. Furthermore, a strong commitment to patients is paramount.

Responsibilities:

• Support GMP activities at the decentralized point-of-care manufacturing sites as part of tech transfers and clinical manufacturing, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.
• Provide 24/7 technical support service for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products meeting quality/regulatory requirements.
• Closely collaborates with Quality Assurance, and other departments in order to support release of short vein-to-vein products. Support implementation of change controls and CAPA.
• Ability to relay technical information and mentor peers. Contribute with technical training both, hands-on as well as documentation.
• Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports.

Job requirements

 Who are you?

• BSc/MSc in life sciences, biotechnology, engineering or related discipline.
• Experience with GMP manufacturing, cell & gene therapy processes, biotechnology products, technology transfer, aseptic processing and technical writing.
• Ability to prioritize effectively and be flexible with changing priorities.
• Responsibility for own projects while pursuing company goals in open collaboration.
• Good interpersonal skills including verbal and written communication are essential in this collaborative environment. Our corporate language is English. Fluency in French is required.
• Self- motivated with can-do mindset, without compromising quality and compliance.
• Understanding of ERP, equipment qualification lifecycle is a plus.

Manufactering engineer