Lead, Sterility Assurance

The Lead, Sterility Assurance will support the implementation and maintenance of highly performant Sterility Assurance Practices, Procedures and Systems on the Catalent MD sites. This position will lead the following areas: Aseptic processing in clean rooms, cleaning and disinfection process, environmental controls, and drug products compliance to regulations and standard in the subject of sterility assurance and contamination control. Review of sterile filter validations, integrity testing and procedures is also required. The individual is expected to interact with a cross functional team including validation, MS&T, QA, Facilities and QC. The primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products to ensure meets GMP compliance standards (EU Annex, 21CFRs, ISO, USP)