Experienced with a demonstrated history of working in the pharmaceuticals industry. Skilled in GxP, Quality by Design, Regulatory Affairs, Analytical method Development/Validation, CMC and Standard Operating Procedure (SOP). Strong Leadership and team builder professional with a Master of Science - MS focused in Analytical Chemistry. Stellar career history includes leadership and technical experience with various dosage forms. Leveraged analytical skills to steer success of drug product development, from raw materials to final API to finish product for analytical method development and validation for NCEs and generics. Maintained stringent compliance with ICH guidelines and various pharmacopoeias (USP, EP, JP, etc.) and setup specifications. Solid knowledge of genotoxic impurities. Developed sophisticated analytical methods and drafted FDA submissions. Proficient in reverse engineering of innovator, discriminating dissolution method development and related compounds method. Stewarded successful of numerous filings from INDs to Phase 3 clinicals and product development. Understanding of IVIVC models, CAPA’s, OOT, OOAL, and SOPs. Experienced in CBE-30/PAS filings for site transfer projects. Effectively worked with CROs/CMOs and performed diligence audits to ensure quality compliance. Commissioned ARD lab for 100+ scientists. Developed budgets, created staff training programs, and oversaw regulatory filing documents for drug substances, drug products, and excipients. Consistently promoted and appraised throughout career.