As a trained synthetic organic chemist, I first encountered medicinal chemistry and radiochemistry in my postdoctoral appointment at Washington University in St. Louis; and am now responsible for development and regulatory affairs at Vanderbilt University Medical Center. Beginning with the fundamental design and preparation of isotopically labeled compounds for use as both imaging and therapy agents, my experience has spanned the spectrum from long-lived radioisotopes (32 P, 131 I, 89 Zr, 64 Cu) to short-lived (68 Ga, 18 F, 11 C) isotopic research and preparations. I have extensive experience with the design and preparation of compounds, as well as their labeling under "hot" conditions in automated synthesis units. Additionally myself and colleagues conduct research into novel methods of radiochemical synthesis using automated radiochemistry synthesis modules. Furthermore, I have been trained in routine operation and maintenance for the cyclotron and automated radiosynthesis modules; as well as extensively in the accompanying chemistry gas handling unit. My duties include consulting with investigators on the feasibility of newly envisioned projects, development of all new and existing radiotracers, creation and maintenance of documents pertaining to GMP productions, training of new and existing lab personnel, validation of all products for administration into either humans or animals, and participating in long-term strategy development for the radiochemistry core. The equipment that I routinely use and train personnel on includes, but is not limited to, automated reaction modules, HPLC equipment, GC instrumentation, and cyclotrons. I lead the VUIIS Radiochemistry core's development and regulatory operations which currently supports 14 radiotracer INDs with another 4 in preparation for submission; and am therefore intimately familiar with cGMP processes and procedures.