Bio

• A passionate analytical scientist working in various leadership positions within a global leading testing company (CRO) in the pharmaceutical industry, within FDA regulated environments including GMP/GLP/GDP operations, familiar with USP, FDA, ICH, and ISO guidelines. • Subject Matter Expert (SME) in Extractables and Leachables (E&L) Testing with both Contract Lab and Pharmaceutical/Medical Device industry experience. Over 10 years of experience with more than 500 E&L studies on a broad range of container closure systems, including pharmaceutical finished packaging, pharmaceutical manufacturing components (SUS, MUS, etc.), and medical devices. Extensive regulatory experience with FDA (CDER, CBER, CDRH, CVM) in terms of E&L studies. • Proven leadership skills by building and developing a successful technical team within a big global CRO. Got 3 major E&L CAPEX/investment approved to purchase almost $2 Million worth of High-Resolution Mass Spectrometers (LC-Orbitrap, LC-QTOF, GC-Orbitrap, GC-QTOF, etc.) since 2016. Expanded the SGS E&L team with over triple in terms of the revenue and staff since joined SGS in 2015. • Excellent interpersonal skills and oral presentation skills with 40+ international conference presentations (invited speaker, session chair, etc.). An enthusiastic speaker frequently speaking at webinars and technical conferences. • Over 15 years of analytical chemistry experience in chromatography (HPLC/UPLC, GC) and Mass Spec (GC-HRMS, LC-HRMS), including analytical method development and validation, unknown structure elucidation, sample preparation, instrument maintenance and troubleshooting. • Ph.D. in Analytical Chemistry with 15+ high-impact journal publications with 300+ citations. Invited reviewer for 60+ manuscripts from 10+ prestigious journals in the field of analytical chemistry and pharmaceutical science (Trends in Analytical Chemistry, Analytica Chimica Acta, Journal of Pharmaceutical Sciences, Journal of Separation Science, Journal of Chromatographic Science, etc.) • Named one of the 60 most influential people working in the pharmaceutical industry in The Medicine Maker’s Power List 2020.