James ET Gebo, MPA National Institutes of Health, Department of Laboratory Medicine, Sterility Testing Service

James Gebo has been the Quality Assurance Manager for the Sterility Testing Service in the Department of Laboratory Medicine at the NIH Clinical Center for the past two years. In this role, he has overseen the development and implementation of the QMS, assisted with the building of cGMP operational processes, and supported the designing of a new Sterility Testing Laboratory for the Service. Before working at the NIH, James spent over twelve years with Avista Pharma Solutions in Agawam, Massachusetts working in the cGMP CDMO and contract testing space. Over his tenure at Avista Pharma, James held various roles starting as a bench tech, moving into a team leader position over the Sterility and Virology testing groups, and finishing as the Manager of Technical Operations where he led the Agawam LIMS team during the development and implementation of a new multisite LIMS. During James' 15 years in the industry, he has worked in all areas of GMP and has extensive experience in microbiological testing for pharmaceuticals and medical devices, controlled environment validations, and electronic system validations.