SPDS ERP Review-May 2015

P a g e | 3

GILEAD SCIENCE, INC., San Dimas, CA 1995 - 1998 $5.3B research-based biopharmaceutical developer and manufacturer, of innovative medicines in primary areas of HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions Research Associate III, Analytical Biochemistry Provided analytical HPLC and GC support for drug discovery formulation group. • Developed, validated, and transferred HPLC and GC raw materials and residual solvent methods for liposomal encapsulated drug products in the presence of plasma and serum. • Performed stability, in-process, raw material, and finished product testing. • Trained peers in GC analysis, theory, maintenance; authored SOPs and test methods. ESTEE LAUDER COMPANIES , Melville, NY 1993 - 1995 $7.9B global leading manufacturer and marketer of skin care, cosmetics, perfume and hair care products Quality Assurance Chemist Provided analytical support for release of personal care products under strict cGMP compliance. • Analyzed active ingredients in sunscreens, volatile organics, and preservatives utilizing ICP, GC, NIRS, and HPLC. • Verified raw material compliance utilizing ICP, FTIR, and USP wet chemistry methods. • Assessed product compliance using color matching for in-process and finished products. EDUCATION B.S. Chemistry, University of Southern California (USC), Los Angeles, CA PROFESSIONAL DEVELOPMENT A2LA Internal Auditing Training Course, Agilent Advanced GC Method Development, Estée Lauder Management, USP Training Courses: Fundamentals of Microbiological Testing, and Validation of Compendial Procedures, USP WCG & AOAC/SCS Joint 2 Day Regulatory & Compliance Conferences COMPUTER PROGRAMS LIMS, Microsoft Office, HP/Agilent Chemstation/Chemstore, Waters Millennium, Empower 3, Live Link/Hot Dox (electronic documentation authoring and approval system), JDE Materials Management System, Active Project (Electronic Project Management System), Sales Force PUBLICATION Co-author of Determination of Ubidecarenone (Coenzyme Q10, ubiquinol-10) in Raw Materials and Dietary Supplements by High-Performance Liquid Chromatography with Ultraviolet Detection: Single-Laboratory Validation. J AOAC Int. 2007 Sep-Oct;90(5):1227-36 PROFESSIONAL AFFILIATIONS American Herbal Products Association, Orange County Regulatory Affairs Discussion Group (OCRA), American Chemical Society (ACS), AOAC & Pacific Southwest Section, American Society for Quality (ASQ), The Real Toastmasters of O.C. Club. ALACC Dietary Supplement Subcommittee, Quality Leadership Network (FDA & Industry) for the Los Angeles District, AOAC St. John’s Wort Working Group, AOAC Expert Review Panels (ERP) for Saw Palmetto Berry,

Omega 3-6-9 Fatty Acids, and Flavonols, AOAC ERP Chair for Coenzyme Q10 Presidential Task Force on Dietary Supplements for AOAC International, 2 year Term

Made with