Description de l'emploi
The Company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. We are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
We entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
- Responsible for the completion of QC testing related to the manufacturing of autologous CART products for clinical trials and commercial operation in a controlled cGMP cleanroom
- Ensure testing is completed in compliance with all applicable procedures, standards and GMP
- Work with Process Development team, Quality and Operations organization to successfully
- transfer process/analytical testing to cGMP facility to manufacture products.
- Conduct analytical testing of raw material/utility, in-process, or final product samples
- submitted to the QC laboratories.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Create, review and approve relevant QC documents, SOP’s and WI’s.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP
- Other duties will be assigned, as necessary
- A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.
- A minimum of 1-2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- Experience in a Quality Control setting is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of CAR-T QC test methods and related equipment is preferred
- Excellent written and oral communication skill are required
- Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
- The candidate must be highly organized and capable of working in a team
- environment with a positive attitude under some supervision.
- Comfortable with speaking and interacting with inspectors.
- This position may require occasional travel to partner sites as business demands.
- This position may require up to 10% domestic or international travel as business demands.
- You speak fluent Dutch and English