The QC Microbiology Specialist, CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
Experience: A Minimum of 2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
Key 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.
· 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.