Jamie M. Singer

GMP Regulatory Specialist Jamie Singer joined ORNL in November 2023, after 28 years in the pharmaceutical industry working on investigational drugs for cancer, Alzheimer’s disease, other neurological disorders and inflammation. Her specialty in current good manufacturing practices (CGMP) and the associated regulations for the manufacture and licensing of investigational new drugs make her a great fit to work with the ORNL teams generating radioisotopes as drug substance intermediates.

Jamie previously served as a Quality and Regulatory project management consultant for start up pharmaceutical companies, with experience in small molecule, mRNA-lipid nanoparticles and radiopharmaceutical investigational drug manufacturing.

She holds Bachelor of Arts degrees in Chemistry and German from the University of North Carolina at Chapel Hill and a Master of Science degree in Regulatory Affairs and Quality Assurance from the Temple University School of Pharmacy.

She is a member of the Regulatory Affairs Professional Society; the American Chemical Society; and the Project Management Institute.