- Experienced pharmaceutical professional with a solid background in Analytical Chemistry, CMC, bioanalysis and DMPK.- Proficient in managing internal and external analytical capacities, establishing analytical quality system to support drug substance/drug product cGMP manufacturing and technology transfer.- Good knowledge of FDA and ICH guidance, compendial (USP, EP, JP) documents, current industry practices, cGMP (US and EU) and GLP regulation.- Strong management skills for CMOs and CROs and constructive interactions with team members and collaborators from the Drug Substance, Drug Product, Supply Chain, Quality, and Regulatory groups to meet program goals.- Proficient in CMC dossier submissions including authoring, review, compilation, publishing and submission of Pre-IND/IND, IMPD, and Annual Reports.- Excellent scientific judgement, problem solving capabilities and interpersonal skills as well as verbal and written communication skills. - A track record in leading the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc), identification of impurities and degradation products, reference standard qualification. - In-depth knowledge of analytical development of small molecules, oral and parenteral formulations in various stages of development (preclinical to phase III).- Extensive experience in in vitro and in vivo metabolism studies and pharmacokinetic analysis and simulation by use of WinNonlin, methods development and validation for quantitation of bioactive compounds (small molecules or peptides) and their metabolites in complex biological matrices by LC-MS and/or LC-MS/MS. - Experienced in protein identification and characterization by LC/MS, nano-LC/MS/MS, LC-UV, stable isotope labeling and peptide mass mapping.