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.

• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred
• Detailed knowledge of the shop floor manufacturing process is preferred
• Comprehensive knowledge of trending using statistical analysis is preferred
• Ability to pay attention to details and follow the procedures 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.