PROFILE Hands-on analytical chemist experienced in biotechnical/pharmaceutical laborator ies with concentrations in method validation, raw material testing

and quality c ontrol. Broad knowledge of cGMP, GDP, EH&S and ICH regulations. Proficient in study design, SOP, technical report writing and data analysis. TECHNICAL SUMMARY *HPLC w/ UV and ELS Detectors *Metrohm Karl Fischer (headspace) *Anderson Cascade Impactor *Ubbelohde Viscosity *Perkin Elmer FT-IR *BioTek Plate Reader *Perkin Elmer Atomic Absorption *Wet Chemistry *Varian Gas Chromatography (headspace) *USP Raw Materials Testing *Dynamic Light Scattering *Capillary iso electric focusing *Vapor Pressure & Freezing point Osmometer *Dry powder sample handling and moisture content control *Operation, maintenance and troubleshooting of laboratory instruments *Millenium, Empower, Galaxie, Tiamo, Microsoft Word/Excel/PowerPoint software PROFESSIONAL EXPERIENCE GENZYME CORPORATION, Framingham, MA 2010 to Present Quality Control Analyst II Provide analytical support for in process, release and stability testing of drug products in a cGMP environment. *Analysis of protein samples by Reverse Phase HPLC *Peer review of data BAXTER HEALTHCARE, ISO 14002, Norwood, MA 2004 to 2010 Research Associate III 2008 to 2010 A member of the Analytical Development Team for six years. Plan and execute experiments for the development of analytical methods for oligo nucleotide drug delivery technology from research to product release testing. * Lead analyst on GC residual solvent and Karl Fischer moisture analysis. * Analysis of oligonuclucleotides by ion pairing reverse phase HPLC * Perform validation of new and current methods * Perform IQ,OQ,PQ's on instrumentation * Raw material testing of cGMP material * Write, review and update raw material part specifications and acceptance proce dures * Write, review and update SOP's, protocols and technical reports Research Associate II 2004 to 2008 Plan and execute experiments for development of analytical methods for protein d rug delivery technology from research to product release testing. * Developed a method and analyzed samples for tert-Butanal residual solvent usin g headspace Gas Chromatograph * Analyzed protein samples by HPLC reverse phase, size exclusion and ion chromat ography * Analyzed samples for polymers including PEG and poloxamer using evaporative li ght scatter detection OMEGA PHARMSERVICES, Milford, MA 2001 to 2003 Scientist III / Group Leader 2003 Responsible for testing of oligonucleotide samples per the clients request, incl uding setting up and monitoring of stability samples. * Managed department daily activities: staffing schedules and oversaw training o f junior personnel. Scientist I/II 2001 to 2002 * Analysis of oligonuclucleotides by ion exchange and reverse phase HPLC, CGE an

d GC * Perform validation of new methods * Write, review and update SOP's ADDITIONAL EXPERIENCE IVEX/NOVACEL, ISO 9002, Newton, MA 1997 to 2001 Lab Technician / Application Specialist Determined the correct masking the customer needed to protect a new surface from damage. Chief operator of the pilot extruder, testing new resins. AALTO SCIENTIFIC, Carlsbad, CA 1990 to 1 995 Senior Lab Technician Manufactured, processed and shipped serum based enzyme/iron/amylase controls and calibrators. EDUCATION BS in Chemistry, Bridgewater State College, Bridgewater, MA PROFESSIONAL DEVELOPMENT Company Sponsored Courses * Oligonucleotide HPLC Seminar, Dionex Corporation, 2009 * Business and Technical Writing Workshop, Vincler Communications, Inc., 2008 * Protein Characterization for Biotechnology Product Development, IBC Profession al Training Academy, 2008 *