QA Micro Associate
il y a 1 semaine
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 instructorled 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, reevaluate and communicate key critical inputs to site environmental monitoring program.
- Identify risks and opportunities in relation to contamination control and assist in followup 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.
Qualifications:
- 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 cellbased products as well as knowledge of Good Tissue Practices
- Detailed knowledge of the shop floor manufacturing process.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with teambased 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.
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