Description
SUMMARY Highly organized, self-motivated Senior Research Scientist with very solid and pertinent experience in drug metabolism and pharmacokinetics (DMPK) support. Extensive knowledge in pharmacokinetic principles and biochemical drug metabolism reactions. Strong scientific and instrumentation background in Pharmaceutical Industry and GLP Analytical work. Excellent skills in analytical method development, assay validation, and research problem solving. Conducted GLP and Non-GLP Analytical work for TK/PK and supported Phase I and II in-house clinical studies for US, Japan and EU submissions. Participated in various project IND submissions and filings. Previous experience as Production and Quality Control chemist in Pharmaceutical, Chemical and Petroleum industries resulted in deep understanding of operations, equipment and plant design, including batch scaling and production troubleshooting. Strong instrumentation knowledge includes operation, calibration and training joiner staff. Experience with method and regulations such as GMP, ISO, ASTM, BP and EPA
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