Summit Regulatory Services, Inc. provides high quality consulting services in support of the System Development Life Cycle of custom and commercial business and quality assurance systems to the FDA regulated pharmaceutical, biotechnology, and medical device industries.Companies consulted while in this position:~ Abbott~ American Red Cross~ Dendreon Corporation~ Fisher Clinical Services~ GlaxoSmithKline Consumer Health~ Merck & Company, Inc.~ Nastech Pharmaceuticals~ Navajo Manufacturing Company, Inc.~ Novartis Business Services - U.S.~ Novartis Consumer Health~ PR Pharmaceuticals~ Sandoz~ Tolmar, Inc.~ U.S. Department of Agriculture (USDA) / Food Safety & Inspection Service~ Zimmer, Inc.

(This company is now Azzur Group)Responsible for management oversight of multiple concurrent projects within the Western Division including scheduling, staffing and training/development of personnel resources to achieve a superior level of quality and customer satisfaction. Primarily responsible for business development in all states west of the Mississippi River.Companies consulted while in this position:~ Analytical Bio-Chemistry Laboratories, Inc.~ Dendreon Corporation~ General Electric~ McKesson Packaging, Inc.

(This company is now Azzur Group)Actively provided consulting services to many various pharmaceutical and biotechnology companies.----------------Also, fulfilled a critical role in assisting the Vice President of Operations in the development and overall project management for all CimQuest operating groups and projects. Also provided technical and business guidance to senior management and Sales & Marketing and actively participated in new business development activities including strategic business planning, marketing/sales planning, sales presentations, proposals and closures. • Provided operational supervision and technical direction to professional staff.• Exercised financial control for projects managed.Companies consulted while in this position:~ Amgen~ Centocor~ Centre Analytical Labs~ Hoffman-LaRoche~ Merck & Company, Inc.~ Merck (Frosst Iberica)~ Merck, Sharp & Dohme ~ NanoSystems (Elan Pharmaceutical Technologies)~ Ortho-McNeil Pharmaceuticals, Inc.~ Protein Design Labs, Inc.

(This company is now Sandoz, Inc.)Management of the design and development of computer-based automation within the QA/QC organization. Responsible for recommending, justifying, demonstrating, and implementing new automation technologies. Acted as the liaison between the QA/QC departments for automation projects. Other responsibilities included project management, documentation (training and user manuals, standard operating procedures, and all documents necessary to support adherence to cGMP’s, cGLP’s, and cGAMP’s), validation (development of Life Cycle documentation and/or execution), training for all levels of personnel, and consulting (provided expertise to other departments implementing automation by serving on project teams and committees).

(This company is now Archimica, Inc.)Implemented and validated a Laboratory Information Management System (LIMS), and for 4 years managed the LIMS that served the needs of over 100 users in 5 separate locations on the company’s campus and over 50 remote locations for the Animal Health Division. Sole Project Manager/Implementer/Validator/Administrator of the LIMS [LabSys LIMS/400] for Quality Control and Animal Health Analytical (AHA) departments. Implemented LIMS interfaced with Intermec bar code readers and label printers. Acted as the liaison between the QA/QC departments and the Animal Health and Information Systems departments for all automation projects, as necessary. Wrote validation protocols, project master plan, Standard Operating Procedures, test scripts, training and user manuals, and Query/400 reports. Maintained the LIMS under change control and in a validated state.

(This company is now Archimica, Inc.)Provided QA, QC, R&D, and Manufacturing support for the company’s intermediate pharmaceutical manufacturing operations. Installed, and for 5 years managed, a robotics system that provided automated analytical testing in a manufacturing environment. Provided documentation and training to support company objectives in compliance to all government and company regulations. For 10 years provided support to production by testing manufactured compounds using Gas Chromatography (GC), High Pressure Liquid Chromatography (HPLC), Infrared Spectroscopy (IR), Refractometer, UV/Vis Spectrophotometer, coulimetric and volumetric titrators, pH meters, and melting point apparatus among others. Designed, implemented and validated a Zymark robotics application in the production facility to provide semi-automated testing in order to decrease sample turnaround times by decreasing the need for QC testing and interaction. Wrote analytical methods, SOP’s, validation protocols, and collaborated in the development of a “Laboratory Chemical Hygiene Plan”. Helped develop and establish the Animal Health Analytical laboratory by purchasing equipment, providing expertise and support for robotics [Zymark], LIMS [LabSys LIMS/400], data acquisition [Perkin-Elmer TurboChrom], and automated calculations [Excel spreadsheet and BASIC program].