Descrizione
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 QA Micro Associate, CAR-T Europe 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 QA Micro 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
- Performs aseptic qualification of manufacturing personnel (e.g. gowning, aseptic processing).
- Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
- Drives the Aseptic Oversight program by execution of manufacturing floor surveillance.
- Actively support process microbiological investigations.
- Write relevant QC documents, SOP’s and WI’s.
- Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
- 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.
Qualifiche
- A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required. Experience within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.
- Aseptic processing in ISO 5 clean room and biosafety cabinets
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices
- Detailed knowledge of the shop floor manufacturing process.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
- Ability to summarize and present results, and experience with team-based collaborations is a must
- You like to explore new paths, to make full use of your knowledge and experience, as well as to expand it, so that new problems also get solutions.
- You see possibilities and you look for them, even when they are not immediately clear.
- You like to work in a team towards a common goal.
- You consider diversity an asset.
- You can deal with procedures and guidelines that require strict application, as well as situations where not everything is clear yet.