Senior Scientist - Analytical
Current• Perform method development and optimization of analytical methods to support testing of novel clinical drug products• Use phase appropriate validation philosophy to perform method verification and validation for client and compendial methods per ICH guidelines• Define and lead analytical activities for projects ranging from preclinical to commercial readiness• Lead analytical function on cross-functional project teams requiring frequent client interactions• Author test methods, development reports, and validation/verification protocols and reports• Drive completion of project analytical deliverables to meet client and internal timelines• Supervise three direct reports including managing workload and providing technical guidance on reports’ projects• Utilize HPLC/UPLC (Empower Software) with UV, ELS, CA, MALS detectors, GC, FTIR, rheometer• Progressed to roles with increasing autonomy and responsibility: Associate Scientist (April 2019-May 2021) to Scientist (May 2021-June 2022) to Senior Scientist (June 2022-Present)