Ph.D. Analytical Chemist with significant experience in drug development and discovery, business development, marketing, and chromatographic and spectroscopic method development and validation. Globally recognized leader in analytical chemistry, analytical method development and validation, chromatography, pharmaceutical chemistry and regulatory compliance. Consulting for private industry, trade organizations, lectures and trained around the world. Excellent multi-tasking, supervisory, organizational, and hands-on problem solving skills. Technical Expertise Includes: GMP, CRO/CMO facilitation and management, separation and identification of both small molecule synthetic and biologic pharmaceutical compounds using technology including: High Performance Liquid Chromatography (HPLC) Capillary to Preparative Scale, Ultra Performance Liquid Chromatography (UPLC), Capillary Electrophoresis (CE) and Gas Chromatography (GC), Mass Spectroscopy (MS and MS/MS), Ultraviolet (UV) and Infrared (IR) spectroscopy, Dissolution, Karl Fischer (KF), and Chiral (enantiomer) Assays.Writing experience includes co-authoring the CMC sections of IND and NDA applications and amendments, books, chapters and articles on validation, combinatorial chemistry and capillary electrochromatography/capillary electrophoresis, over 90 contributed and invited manuscripts, four patents, and over 225 contributed and invited presentations at various technical symposia and conferences around the world. Serving as an expert witness and on the Scientific Editorial Advisory Board of LC/GC Magazine since 1998, as co-author of the popular Validation Viewpoint Column, author of the Innovations in HPLC feature column, and a contributing and freelance writer.