Senior Research Scientist, Method Development And Validation Group
Current• Lead analytical method developer specializing in assay/impurities methods, impurity identification (structural elucidation), and mapping degradation pathways• Subject matter expert on HPLC, GC, GC-MS, and LC-MS techniques of analysis• Technical writer authoring documents such as SOPs, methods, protocols, specifications, reports, CAPAs, and change controls• Regularly performs witnessing, technical review, and peer-review of data• Conducts laboratory investigations and OOS investigations, including design of crucial experiments to challenge results and troubleshoot analytical procedures• Regular practice with a variety of UPLC and HPLC techniques (reversed phase, normal phase, ion exchange, ion chromatography, ion-pairing, chiral, and size exclusion)• Works with methods for wide array of small molecule and large molecule targets• Multiple roles over time, including small group leader (managing up to four employees), project manager, laboratory manager, safety committee member, customer interactions, candidate interviews, and employee training• Designs and executes method validation and method transfer studies• Responsible for compliance with cGMP and GLP regulatory environments as well as working within guidelines per ICH, FDA, USP, and EP • Calibration, preventative maintenance, repair, and troubleshooting of analytical instruments (HPLC, UPLC, GC, GC-MS, and LC-MS)• Conducts scientific literature searches and review of papers for supporting analytical research and development• Trained in Six-Sigma and 5S principles for operational excellence and efficiency• Founder of Scientific Forum initiative for the site - a monthly event providing opportunities for employees to perform presentations and engage in discussions on relevant scientific topics • Contributes to onboarding and validation of LIMS system• Collaborates with scientists from pharma companies on drug development projects, including industry leaders