SPDS ERP CVs - DEC 2017

Braun/McGaw Medical Inc. (Irvine, CA) Senior Staff Scientist, Pharmaceutical Development Jun.1997- Aug. 1999 • Filed NDAs for parental drug products with drug substance/drug product development, method validation and method transfer. • Supervised research scientists in parenteral pharmaceutical drug substance/drug product and nutritional formulation developmental analysis. • Investigated leachables/extractables of parenteral plastic containers using SPE, GC, HPLC, LC/MS/MS, LC/ELSD, GC/MS, GC/FTIR, H 1 and C 13 NMR, and x-ray diffraction. • Managed lab reference standard synthesis for leachable/extractables. • Developed LC/MS/MS methods for metabolite identification and quantification in biological matrices for PK studies. • Supported stability and impurity programs with HPLC, LC/MS/MS, LC/UV/MS, and LC/RI/MS techniques. Established mass spectrometry laboratory procedures and practices. May 1995-June1997 • Expertise in the structure elucidation of impurities and degradation products of drug substances (APIs) and drug products by mass spectrometry. • Provided data for regulatory filing of 4 drug master (DMF) files. • Conducted preparative HPLC separation of impurities from active drug ingredients. Teva Pharmaceuticals USA (Mexico, MO) Senior Research Chemist, R&D Department Pacific Northwest National Laboratory (Richland, WA) Post Doctoral Research Associate Mar. 1994-May 1995 Bioanalytical research with characterization of proteins, DNA, RNA, and supramolecular complexes using ESI-MS, LC/MS and CE/MS techniques. Designed, constructed and characterized a novel space-focusing Time-of-Flight mass spectrometer. EDUCATION B. Sc. in Chemistry, Nanjing University, China, 1982 M. Sc. in Chemistry, Dalian Inst. of Chem. Phys., Chinese Academy of Sciences, 1985. Ph. D. in Chemistry, University of California, Irvine, 1991. Post-Doctoral Research, University of Pittsburgh and Pacific Northwest National Laboratories. 1992-1995. • Characterized proteins and carbohydrates in natural products. • Supported immediate and sustained release formulations.

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