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. |