R&D Chemist
CurrentOrganize and conduct product development studies for FDA applications and correspondence including stability programs, design of experiments (DOE), compatibility studies and other research following GMP.Optimized lyophilization processes using DOE to set a design space and to model process parameters.Redesigned a compounding process to solve urgent issues related to component loss for GMP stability lots.Reduced particle size test variability for an inhaler product from above 15% RSD to less than 5% RSD.Develop, validate, and execute analytical chemistry methods (UPLC/HPLC, ICP-MS, GC, IC, etc.) for evaluation of quality attributes including product or excipient assays, impurities, ID, water content, etc.Compose documents including validation protocols, reports, standard operating procedures and notebooks.