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Resume of WHN, Ph.D.
Consultant

EXPERTISE AND SERVICES

Scientist, Biopharmaceutical Product and Process Development Consultant, Nucleic Acids Assay Development Specialist, Pharmaceutical, Life Sciences, Biotechnology Industries Consultant, Expert Consulting Services
Expertise in product and process development, including knowledge of moving biopharmaceutical products through an R&D pipeline to manufacturing, IND filing and clinical trial.

This consultant's experience includes establishing a project team, managing product development process at all levels, and design of product certificates of analysis. This consultant has hands-on-experience with initial analytical assay development through establishment in QC, regulatory submissions; project management: proposal preparation, planning, reporting, budgeting, staffing, regulatory IND and DMF filing for new biopharmaceutical products.

Additional capabilities include lab management: functional molecular biology lab setup, supervising, training; molecular biology: nucleic acids assay development and validation-GMP (good manufacturing practice) assay development for characterization of pharmaceutical products, such as DNA genotyping, plasmid DNA forms, plasmid DNA identity, plasmid or gene copy number, levels of residual RNA, residual host chromosomal DNA. Assay validation according to FDA and ICH guidelines. Assay transfer and establishment in QC; DNA diagnostics/molecular genotyping: PCR, RFLP, SSCP, allele-specific PCR, allele-specific hybridization, Southerns; Recombinant DNA: Ligation, transformation, electroporation, clone screening; Microbial genetics: All essential microbiological techniques including random and site-directed mutagenesis, mating and mapping, constructing strains of desired genotype, transformation and maintenance, clone screening, yeast two-hybrid system, yeast tetrad analysis; Protein expression: Yeast and bacterial vector construction, secretional and intracellular expression of recombinant proteins in yeast, Northerns, Westerns, recombinant protein purification; Protein chemistry: Size fractionation, ion exchange chromatography, affinity chromatography, enzymatic assays, spectrofluorimetry; teaching and training

PRINCIPAL INDUSTRIES SERVED
Biotechnology, Chemicals, Food Processing, Health and Beauty Aid Products, Medical Devices and Equipment, Packaging, Pharmaceuticals

EDUCATION
Ph.D., Genetics, St. Petersburg State University

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing project management and consulting services to the pharmaceutical, life sciences, biotechnology industries, with specialization in molecular biology, and related expertise to a wide variety of clients.

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Scientist II, Scientist I, Specialist II, vaccines and diagnostics firm

Head of the Nucleic Acids Assay Development group. Analytical project management in biotechnology GMP environment. Designed and developed a variety of novel DNA and RNA analysis methods, validated assays according to ICH guidelines. Prepared SOP (standard operating procedure) protocols, transferred assays to QC. Established a solid and unique analytical platform for characterization of DNA-based pharmaceutical products according to FDA guidelines. Coordinated and oversaw all analytical activities required for product characterization and release. Designed certificates of analysis for the nucleic acid-based products. Composed analytical parts of the IND package for FDA filing. Prepared NIH grant proposals for HIV DNA Vaccine. Supervised and trained staff members in the execution of DNA and RNA analysis procedures.

Post-Doctoral Staff Member, Biology and Biotechnology Research Program, Lawrence Livermore National Laboratory, CA

Designed and constructed novel vectors for protein expression in yeast Saccharomyces. Expressed and characterized human XPA and XRCC1 DNA repair proteins.

Visiting Scientist / Consultant, Department of Virology, University of Turku, Finland

Established a PCR-based DNA genotyping platform for determining genetic predisposition to insulin-dependent diabetes mellitus, multiple sclerosis and rheumatoid arthritis.

Assistant Professor, Department of Medical Genetics, St. Petersburg Pediatric Medical Institute, Russia

Delivered series of lectures, instructed and trained medical students in theoretical and practical approaches to DNA diagnostics of human inherited diseases. Trained and supervised a group of researchers to investigate genetic nature of predispositions to human diseases, and to develop methods for DNA diagnostics.

Ph.D. Candidate, Laboratory of Genetics of Eucaryota, Petersburg Institute of Nuclear Physics, Russia

Discovered that spontaneous conversion events in yeast mitosis involve extended regions of yeast chromosomal DNA.

Research Associate, Laboratory of Biochemical Genetics, St. Petersburg State University, Russia

Purified and characterized phosphoribozylaminoimidazole carboxylase from yeast Saccharomyces cerevisiae.

HONORS AND AWARDS
Fellowship from European Society of Human Genetics
Research grant from US Department of Energy
HIV Vaccine Development Resources - GMP DNA Manufacturing

PUBLICATIONS
Author of numerous publications in areas related to biotechnology GMP, novel DNA and RNA analysis methods, and more. Holds patent for method for estimation of bio-organic content in geological samples.

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

Read articles by this associate:

Quantitative RFLP: A Procedure for Quantitation of Diphtheria Toxin Gene CRM197 Allele

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Case Studies

Scientist, Biopharmaceutical Product and Process Development Consultant, Nucleic Acids Assay Development Specialist, Pharmaceutical, Life Sciences, Biotechnology Industries Consultant, Expert Consulting Services
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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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