Education: 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.
Experience: 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.
Capabilities, Knowledge, and skills:
- 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. - Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice. - 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 in NJ or PA as business demands. - This position may require up to 10% domestic or international travel as business demands.