Scientist, Cmc Analytical Sciences
• Analytical methods (HRMS, LCMS, HPLC, dissolution, NMR) development and optimization for small molecule and amino acids drug from pre-clinical to Phase II. • Analytical methods validation for raw material, drug substance, final product release, in-process controls, and stability testing. Designed and implemented experiments to assess analytical deviations and possible cause.• Internal supports for formulation, QC, drug development and product development.• CRO evaluation, data review and approval, protocol and report validation• Operated in compliance with current GMP and GLP according to ICH and FDA requirements.