SPDS ERP CVs - DEC 2017

ASSOCIATE DIRECTOR, SCIENTIFIC AFFAIRS, Nov. 2003 to July 2004 Pyxant Labs, Colorado Springs, Colorado • Provide technical leadership, within a cooperative team environment, to all aspects of experimental design, interpretation, and client contact for GxP analytical chemistry contract research support. • Assist in establishing bioanalytical division in a company that has traditionally focused on environmental analysis with EPA regulations • Establish GLP and SOP procedures and practices for quantitative bioanalytical analysis (method development, validation, and sample analysis of biological samples) under FDA policies and guidelines • Design and implement efficient systems for all aspects of conducting bioanalytical studies including sample receipt, tracking, method development, method validation, sample analysis, data review, data documentation, data reporting • Design and implement training program for employees • Provide direction for the company as a member of management • Design and evaluate assay method development and validations • Troubleshoot instrument and assay issues • Train lab personnel in areas including sample preparation, instrument operation, calculations, documentation, and reporting. • Train other employees on project management and client communication and relationships • Write and review study proposals, protocols, and reports SENIOR RESEARCH SCIENTIST, March 2003 to Oct. 2003 Tandem Labs, Salt Lake City, Utah • Extracted and analyzed drugs from biological samples for discovery, validation, and sample analysis projects according to prescribed GLP and SOP procedures and practices as well as FDA policies and guidelines and project directives • Designed and evaluated assay validations • Developed methods and performed assay troubleshooting • Performed maintenance, trouble-shooting, and repairs on advanced instrumentation • Reviewed analytical data, methods, equipment validations, and study reports • Trained other laboratory personnel PROJECT MANAGER, Aug. 2002 to Oct. 2003 Tandem Labs, Salt Lake City, Utah • Managed daily activities of bioanalytical (pharmaceutical) studies. Took overall responsibility for the study conduct and reporting. Maintained project schedule information (sample receipt, analyses required, data and report timelines, etc.). Ensured client contract and technical specific actions were met, scheduled equipment and laboratory personnel, and ensured that personnel were trained/certified for work that was performed. • Ensured that all raw data was properly documented and maintained and projects were conducted in accordance with applicable client and/or bioanalytical division SOPs. Ensured applicable GLP guidelines were followed, reviewed data and final report for accuracy, and responded to QAU project specific inspections.