• Expertise in process chemistry including synthetic route scouting, design, process optimization, mechanistic studies, safety assessments, salt screening, crystallization, purification, technology transfer for scales up from lab to kilo lab, cGMP manufacturing with one NCE on market, three drug candidates in Phase 2 clinical trials and several in preclinical studies• Extensive experience in managing CDMOs/CMOs/CROs for outsourced CMC projects including API chemical process R&D and manufacturing, analytical method development and validation, and DP pre-formulation and development by providing strategic direction and ensuring implementation• Excellent collaboration experience with biology, analytical chemistry, bioanalysis, DMPK, toxicology, formulation, QC, QA, and regulatory affair colleagues for reviewing and approving protocols and reports, drafting Module 3 and 2, and filing IND and NDA• Strong knowledge and experience with analytical instrumentation (HPLC, GC, IR, NMR, UV, MS, DSC, RC1, TGA, XRPD, KF) and interpreting scientific data based on these instruments• Broad drug discovery and development experience in multiple therapeutic areas including cancer, infectious diseases, inflammation, pain, CNS disorders, diabetes, and rare diseases like Cystic Fibrosis (CF) and Recessive Dystrophic Epidermolysis Bullosa (RDEB)• Excellent medicinal chemistry knowledge and skills to solve critical issues related to affinity, selectivity, drug property, PK, PD, toxicology; extensive structure and fragment-based drug design experience including using computer-aided tools like Schrodinger Suite and MOE• Inventor of 4 clinical (Phase 1 and 2) and 6 pre-clinical drug candidates with 22 U.S. issued patents and 21 patent applications: author of 46 publications with over 1,400 citations