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