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 requirementsWho 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.
