EMS associate
Publication date:
10 October 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Ghent
CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.
We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we are developing a new production site.
We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The EMS Associate, CAR-T Belgium is part of a team responsible for providing microbiological and aseptic oversight and contamination control of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. The EMS Associate will be based in Ghent, Belgium.
Major Responsibilities:
- Work with Process Development team, Quality and Operations organization to ensure contamination control of facility to manufacture products, consistent with cGMP and Janssen requirements.
- Lead environmental monitoring performance qualification of the CAR-T facilities & utilities.
- Define an end-to end routine environmental monitoring program for the CAR-T facilities & utilities.
- Write relevant environmental monitoring protocols, reports, SOP’s and WI’s.
- Set-up and maintain the environmental monitoring trending program.
- Actively support process microbiological investigations and assist in definition of corrective actions.
- Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.