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Resume of JHH
Consultant

EXPERTISE AND SERVICES

Bioscience Manager, Microbiologist, Bio-Technologist, Scientist, Product Quality Assurance Consultant, Specialist, Forensic Analysis Investigation, Expert Witness Testimony, Consulting Services
Expertise in management of product quality systems, training and implementation of GLP, cGMP, GCP, and other FDA guidances (including 21 CFR Parts 11, 820, & ICH Q7A), documentation and lab facility review, FDA submissions and responses, analytical / method development, chemistry, molecular biology, microbiology, and clinical research.

Highly experienced in areas including supervising, training, and hiring, quality control operations supervision, quality control lab setup, software development, quality systems, safety, assay development and qualification.

Additional experience and specialization includes information systems, regulatory affairs, development of IQ, OQ, and PQ protocols for qualification and / or validation of analytical instruments; twenty years experience with computers using various operating systems (Windows, Macintosh, Linux); MS Office and graphic design software; programming in Fortran, Pascal, Cobol and Visual BASIC; fully trained and certified in validation of computer systems and software validation as per 21 CFR Part 11

PRINCIPAL INDUSTRIES SERVED
Biotechnology, Chemistry, Health & Beauty Aids Products, Medical Devices, Pharmaceuticals

EDUCATION
Working toward M.S. in Bioscience Management, George Mason University, Arlington VA
Professional development of highest level corporate management within the biosciences.
University of Cambridge (Fitzwilliam College), Cambridge, UK.
International residency focusing on differences in business practices and economics between America and the European Union specifically in the Biotech, Pharmaceutical, and Medical Device areas.
M.B.A., University of Mary, Bismarck, ND
B.S. from the College in Science and Mathematics, North Dakota State University, Fargo, ND
Majored in Microbiology & Biotechnology / Minored in Chemistry
Completed 12 credits of graduate work toward M.S. in Biochemistry.
A.S. in Computer Science, Olivet Nazarene University, Kankakee, IL

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing project management, bioscience management, microbiology, biotechnology, product quality systems management, GLP, cGMP, GCP, and FDA regulatory consulting and related expertise for a wide variety of clients.

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Case Studies

Senior Manager of Product Quality Systems, Hematech, Inc., Sioux Falls, SD

Supervision of daily quality control operations throughout company. Managed development of specialized software database exclusive to Hematech. Responsible for federal regulations training and implementation. Designed setup of the quality control lab. Responsible for quality assurance of all documents and processes. Developed and qualified assays (ELISA, RT-PCR, SEC, Western blots, etc.). Member of the following committees: Software development (Chairman), Quality Systems, Safety, Assay Development, Institutional Review Board, and Regulatory Affairs. Assisted in all aspects of Information Systems.

Analytical Science Consultant, Quintiles Consulting, Mundelein, IL

Provided techniques for improving analytical methods and / or validations for products and systems using FDA, GMP and GLP industry guidances. Trained scientists in more efficient and cost saving method development and analytical skills. Composed protocols, Master Validation Plans, test scripts, work instructions, and SOP documents for clients. Recommended new equipment and/or more advanced technologies to improve work flow.

Projects included Pfizer, Kalamazoo, MI
Implemented 21 CFR Part 11 with both the Computer Compliance and Quality Control / Assurance divisions. Developed IQ, OQ, and PQ protocols for qualification and/or validation of many analytical instruments (including Bran+Luebbe TRAACS, Malvern Mastersizer 2000, Thermo Spectronic Unicam UV, and Bruker-AXS XRD systems among others), computer systems, and software packages. Oversaw senior level managers and QC professionals to assure proper operation of instruments and proper security and flow of data.

OraSure Technologies, Beaverton, OR
Utilized molecular biological techniques (Western Blots, protein purifications, ELISAs, and Spectrophotometer methods). Implemented cost-effective analytical methods to increase productivity. Organized cross-departmental team meetings for brainstorming sessions on increasing productivity & lowering costs.

Analytical Scientist/ Methods Development Chemist, Pracs Institute, Ltd., Fargo, ND

Served as Team Leader of Gas Chromatography team. Reviewed and performed QA and QC on paperwork and other documentation produced by other analysts. Comprehensively trained in FDA, GLP, GCP and GMP guidelines. Served as Chairman of Analytical Safety team, dealing with all safety issues and concerns within the lab. Developed and validated analytical methods used for the analysis of various biological and pharmaceutical compounds; in total, developed and validated 56 different methods. Developed the above mentioned analytical methods using HPLC w/ UV, FLD, and ECD detection, LC-MS, LC-MS-MS, GC-MS and CE. Performed techniques including solid-phase extraction, organic synthesis, derivitization reactions and sample purification techniques, and trained other employees in same. Wrote analytical procedures, protocols and SOP documents for tasks performed within the lab. Repaired (and in some cases rebuilt) and performed metrology on HPLC, GC-MS and LC-MS-MS systems. Worked with Clinical Research department on setup and performance of projects related to both clinical and analytical work. Served on the Clinical Research Quality Management team. Assisted in the planning and purchasing of equipment and supplies. Performed Software and computer validations on new systems received in the lab. Interacted with clients for various projects and represented the company at national conferences within the biological and pharmaceutical fields.

Research Assistant, USDA Northern Crops Institute, Fargo, ND

Inserted genetically engineered DNA sequences into sunflower cells to produce enzymes for a natural biocontrol mechanism. Performed experiments using Western, Southern, & Northern blots, gel electrophoresis, SDS-PAGE gels, DNA sequencing, PCR, ELISA, RIA, microbiological techniques, spectrometry and fluorometry. Prepped and purified plasmids using purified bacterial and yeast cultures. Screened cDNA libraries, purified protein extracts, and performed cell and tissue culture of sunflowers. Certified in radioisotope handling.

Research Assistant, NDSU Entomology Department, Fargo, ND

Performed experiments in the lab and out in the field on the natural biocontrol of grasshoppers. Set up experiments, raised the specimens, collected and analyzed data and wrote up documents detailing the results. Applied some of this research toward senior biotechnology project at North Dakota State University.

Lab Technician, USDA Bioscience Lab, Fargo, ND

Collected and raised various species of flies for work leading toward the biocontrol of screwworm infestations. Dissected and analyzed the flies to look for specific traits. Sorted out flies by sex and genetic differences. Cross-bred various strains to help enhance various genetic traits.

ADDITIONAL EXPERIENCE

Eight years experience in supervising, training, and/or hiring employees and keeping documented accounts of their training.

Over eight years in quality service work including training and implementation of GLP, cGMP, GCP, and other FDA Guidances (including 21 CFR Parts 11, 820, & ICH Q7A); performed reviews of documentation and lab facilities; organized FDA submissions and responses.

Twelve years experience in fields of analytical /method development chemistry, molecular biology, microbiology, and clinical research.

Twenty years experience with computers using various operating systems (Windows, Macintosh, Linux); MS Office and graphic design software packages; programming in Fortran, Pascal, Cobol and Visual BASIC; fully trained and certified in validation of computer systems and software validation as per 21 CFR Part 11.

PROFESSIONAL REGISTRATION
FDA-GLP certified, Society of Quality Assurance, Charlottesville, VA.
21 CFR Part 11 certified through Pfizer/Legacy Pharmacia training program, Pfizer, Kalamazoo, MI.
Radioisotope handling certified to USDA specifications, USDA Northern Crops Institute, Fargo, ND.

PROFESSIONAL AFFILIATIONS
Society of Quality Assurance (SQA), FDA-GLP Section and Biotechnology Section
American Chemical Society (ACS)
American Association of Pharmaceutical Scientists (AAPS)
Minnesota Mass Spec Society
Minnesota Chromatography Forum

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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