Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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 Coordinates routine and special testing of samples by outside analytical labs.  Ensures all safety and quality standards and production requirements are met.  Uses Laboratory Information Management System (LIMS) as a tool in conducting investigations and reporting results.  Researches and recommends equipment and process improvements necessary to enhance our analytical capabilities Research Associate, UCLA Chemistry and Biochemistry January 2010 -July 2010  Develop robust HPLC methods for the separation, resolution and purification of isomeric drug products.  Optimizing and validating HPLC methods for drug analysis.  Reversed Phase (and Normal Phase) HPLC and tandemMass Spectrometry for the analysis of potential drug candidates after total organic synthesis.  Trained and supervised graduate students and post docs in developing accurate and precise methods of analysis, mainly by HPLC and Mass Spectrometry. Analytical Chemist, Infusion Systems, LLC April 2009 -January 2010  Execute USP and European Pharmacopeia methods per FDA guidelines in a manufacturing environment.  Design and execute a Stability Protocol for pharmaceutical drugs in Infusion pumps (Medical Device) and also to determine shelf lives.  Develop and validate HPLC methods when USP and EP methods of analyses are inadequate, unavailable or exceptionally time consuming. Analytical Chemist, MannKind Corporation March 2005 -April 2009  Developed and Optimized HPLC-MS methods for Total Drug Analysis.  Developedmethods to quantitate hydrocarbons, polymers and other volatile and non-volatile organics.  Developed Plasma Protein Precipitation and Solid Phase Extraction techniques for the extraction of drugs and small molecules from serum, plasma or whole blood matrix.  Support PK and TOX studies: ADME Assays  Have developed methods for the determination of LogP and Aqueous Solubility for ADME studies.  Developed HPLC methods to determine drug compound purity and aqueous stability  Assisted in the determination of Microsomal Metabolism Assays.  Extensive cGLP and cGMP training.

08/09/2018