Experienced pharmaceutical scientist able to assist in litigation involving scientific evidence as well as patents and trademarks to include evaluation of science issues relevant to business mergers.

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SUMMARY OF QUALIFICATIONS Pharmaceutical industry manager experienced in all phases of product development including analytical chemistry methods development, manufacturing, validation, quality assurance, research, network administration, regulatory affairs management, information technology management, and FDA audit preparation and management Strong background in project, departmental and contract management as well as computer system validation and sales support Experienced in negotiating with FDA, contract research organizations, and university research groups Specialized information technology training and certifications in Windows NT/2000 and Linux WORK EXPERIENCE 2001 - 2004 Director of Regulatory Compliance/Quality Assurance Preclinical Research & Development Romark Laboratories, L.C. - Tampa, Florida Supervised the quality assurance and regulatory affairs departmental staff and projects Responsible for quality management of multiple contractors and vendors Provided timely and accurate reports to management, research staff, and clinical investigators on clinical programs, manufacturing processes, audits, and business operations Manage IND and annual report submissions to FDA and oversee all CMC related activities within company product lines Prepared New Drug Application (NDA) and submitted to FDA resulting in a six month review and approval of a new chemical entity and generating new product sales for emerging growth company Direct research involving novel pharmaceutical compounds for new therapeutic indications. Initiate research on FDA approved compounds to determine new therapeutic targets Manage manufacturing suppliers to ensure timely manufacture and delivery of marketed products Responsible for oversight of international research program to develop new compounds at the University of London, University of Liverpool, and company headquarters in Tampa, Florida Responsible for evaluation of contract research organizations for scientific and regulatory compliance Manage multiple projects for research, manufacturing, quality assurance, and business operations Implement Linux-based computational chemistry program for the discovery of new drugs Collaborate with marketing department to translate chemical research into marketed product initiatives Provide comprehensive technical training to district sales managers Interface with clinical staff and clinical investigators to conduct data quality audits of clinical trials data to include IRB compliance practices, GCP compliance, and data integrity resulting in five successful FDA audits with no 483 citations Negotiate with FDA regarding regulatory submissions, content, and labeling. Oversee computer network upgrades and computer system implementation projects 2000 - 2001 Manager of Quality Assurance Romark Laboratories, L.C. - Tampa, Florida Developed and implemented comprehensive quality assurance program for pharmaceutical company conducting multinational, multi-site clinical trials on four continents Provided leadership and training to clinical research staff involving GCPs, FDA regulations, site documentation requirements, Case Report Form verification, data management, and audit interview techniques. Train monitoring staff and clinical investigators on GCPs and how to handle FDA audits Developed comprehensive set of SOP's for clinical research, quality assurance, and marketing departments Conduct due diligence audits of manufacturing sites for GMP compliance Train consultants and manufacturing staff on 21 CFR Part 11 compliance and audit expectations Responsible for evaluation and upgrading of company Information Technology program 2001 - Present Faculty Member University of Phoenix - Tampa, Florida Instructor for graduate and undergraduate courses in Web Server Administration, Project Management, Windows 2000/NT, Unix, Networking and MCSE certification Responsible for curriculum development and revision for classroom and online teaching environments 1999 - 2000 Lab Systems Administrator/IT Manager - Chemical Engineering Dept. Washington State University - Pullman, Washington Administration of a mixed operating system computer network which supports 150+ chemical engineers, chemists, and students and connects 15 analytical chemistry research laboratories. Utilized chemistry laboratory experience and education to implement and support laboratory data acquisition software and chemical process simulation software. Performed systems analyses and report recommendations to senior management Management of multiple chemical research support projects, helpdesk work orders, and contractors Performed troubleshooting and repair of HPLC chemistry laboratory equipment Negotiated and contracted with vendors and external departments 1999 - 2000 Adjunct Faculty IT Instructor - Computer Network Systems Technology ITT Technical Institute - Spokane, Washington Provided classroom instruction in software implementation and network administration skills for new program in information technology. Developed standards for teaching and for IT program. Network administrator for classroom training network of Windows NT Servers and NT Workstation PCs used for Microsoft training courses. 1999 System Administrator - Information Services Dept. Solvay Pharmaceuticals, Inc. - Atlanta, Georgia Utilized analytical chemistry and information technology expertise to administer a laboratory data acquisition system supporting Preclinical Research and Development department scientists Validated and implemented new computer systems for entire research and development division according to 21 CFR Part 11 requirements. Coordinated a team of validation engineers, consultants, users, and department managers Managed multiple projects and helpdesk work orders Trained chemists on Windows 95, Windows NT, Perkin Elmer Turbochrom enterprise resource software, and GMP computer systems practices Leader of multidisciplinary project teams tasked with software systems implementation and developing training procedures for chemists and QA auditors Troubleshoot GC and HPLC equipment and assist in laboratory investigations 1996 - 1998 Associate Scientist/Scientist I - Preclinical Research and Development Division Solvay Pharmaceuticals, Inc. - Atlanta, Georgia Performed experiments on biological samples using chromatographic methodologies (GC, HPLC, GC/MS, HPLC/MS) for pharmaceutical compounds and metabolites Performed analytical chemistry method validation of HPLC and GC analytical assays using GLP protocols Wrote reports regarding the scientific results of clinical and preclinical research studies for FDA submissions Utilized GLP and GMP standards to audit research for quality assurance purposes Managed external research projects at contract research organizations (CROs) including budgets, contract negotiations, and scientific review of research Lead and managed preclinical research department implementation of Windows NT based Turbochrom data acquisition system Wrote systems documentation and SOP's for method validation, chemical instrumentation, and training Provided user support to chemists for Windows NT chromatography data acquisition systems 1992 - 1996 Analytical Chemist - Clinical Toxicology Dept. SmithKline Beecham Clinical Laboratories - Atlanta, Georgia Conducted clinical toxicology and analytical chemistry experiments on bodily fluids for doctors, hospitals, pharmaceutical clinical trials, and state crime laboratories Experienced with thin layer chromatography, HPLC, GC, GF-AAS, GC/MS, and UV-VIS for controlled substances and pharmaceutical compounds 1991 - 1992 Analytical Chemist - GC/MS Section Law Environmental National Laboratories - Atlanta, Georgia Provided hazardous waste site investigation project support to engineers and scientists by analyzing water and soil samples for volatile organic compounds Maintained laboratory instruments and upgraded computer systems used in laboratory experiments EDUCATION 1996 Master of Science, Chemistry Georgia Institute of Technology - Atlanta, Georgia 1991 Bachelor of Science, Chemistry North Georgia College - Dahlonega, Georgia Microsoft Certified Systems Engineer - Windows NT and Windows 2000 Comptia Network + Certification PROFESSIONAL AFFILIATIONS AND ACTIVITIES Visiting Scientist at the University of London's School of Hygiene and Tropical Medicine Faculty at the University of Phoenix-Tampa Campus American Chemical Society, member American Association of Pharmaceutical Scientists, member Society for Quality Assurance, member Review committee, Poster exhibitions, American Association of Pharmaceutical Scientists Science Consultant, Technical Advisory Service for Attorneys Expert Witness on Scientific Evidence, Federal District Court, Gainesville, GA Specialized training: Curriculum Development and University Instruction Specialized training: Good Clinical Practices (GCP), Clinical Trial Monitoring, Good Manufacturing Practices (GMP), Good Laboratory Practices(GLP), How to Handle an FDA Audit, and Statistics Contributing writer, The Computer Companion magazine, Computerbits.com, and Writers.net Assist FBI in computer hacking case in February 2000

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