PrincipalScientist

SUMMARY

Biochemist with extensive experience in biotechnology industry including a broad background in developing diagnostic kits, managing projects for the development of analysis software, and modifying accessory instruments according to Design Control. Developed all aspects of software from defining Design Goals to final commercialized product except for the actual coding. Recommended modifications to instruments to minimize false positive results and to improve diagnostic kit quality and performance. Strengths include innovation, follow-through, teamwork, self-starter, and analysis. Recognized resource by R&D and Technical Services for software and hardware troubleshooting, problem solving, and technical issues. Initiated improvements, formulated plans of action, and implemented those plans to their logical conclusions. U. S. citizen.


RECENT PROFESSIONAL EXPERIENCE

DIGENE CORPORATION, Gaithersburg, MD (formerly in Silver Spring) •••••
Digene is a manufacturer of diagnostic DNA kits for detection of sexually transmitted diseases.

Principal Scientist (•••••), Principal Systems Scientist (•••••)
* Managed projects by Design Control, improved and integrated customer friendly software to systematize the analysis of diagnostic data, defined functional and testing requirements. Wrote technical and internal training manuals and Standard Operating Procedures for software installation, Quality Control testing, and manufacturing. The software is used worldwide by more than ••••• new customers since •••••

* Compared, evaluated and modified electronic calibration plate for commercialization for routine instrument checks and for internal use for calibrating the instrument. The product is being used by all customers, repair technicians, and Digene Quality Control since •••••

* Reduced the false positive results by 4 fold by determining the major source of instrument related false positive results and recommending changes within the instrument.

* Reduced false positive results by ••••• fold by identifying the cause of microplate related false positive results and communicated conclusions to manufacturer who implemented changes in manufacturing.

* Discovered inconsistencies in an automated instrument compared to manual process, quantified the statistically relevant effect, and communicated results to management with recommendations for product improvement. The recommendations have been tabled.

* Hired and trained new scientist to head the cross-functional scientific team for software improvement and trained him in Design Control.

* Honored with two Digene Non-Stop Awards (DNA) for interdepartmental computer and instrumentation assistance and one Digene Teamwork Award for analysis designed to detect the presence of a sub-optimal component that could lead to false positive results.

* Served as the principal point person for software and instrumentation related questions for R&D, Technical Services and Instrumentation Group.

Senior Scientist (•••••)
* Managed qualitative software development project consisting of custom Excel macros utilizing an outside software development team for international use including Operating Systems and Excel in 6 languages that is still in use in over ••••• sites in Europe and the rest of the world.

Systems Manager (•••••)
* Managed the newly created Systems group including supervising two scientists to develop a DNA diagnostic kit and analysis instrumentation and software. Completed in less than ••••• months and received FDA clearance within 6 weeks of submission. This luminometer is used by more than ••••• customers worldwide.

* Wrote interim analysis software and self-trained on Excel Visual Basic to improve customer friendliness of software. Coded new software, validated it, and all of the customers software was upgraded to this version.

* Recommended instrument to be used and worked with manufacturer to improve instrument including increasing sensitivity ••••• fold; currently used worldwide by all customers.

Clinical Studies Manager (•••••)
* Managed two technicians to test and type •••••,••••• cervical specimens for Human Papillomavirus DNA.

* QCd and manufactured reagents necessary for DNA assay including purifying antibody and improving the well coating process and antibody detection reagents.

* Improved throughput of clinical specimens by converting the labor intensive tube assay into a •••••well microplate format, improved assay sensitivity 5 fold, reduced testing costs by ••••• fold, and increased throughput per technician by 2 fold.

* Managed two technicians, each testing ••••• samples per day.

* Programmed software for data analysis in both tube and microplate format. The software was used in the clinical laboratory and during clinical trials.

CAMBRIDGE BIOTECH CORPORATION, Rockville, MD •••••
(formerly Biotech Research Laboratories, Inc.)
One of the original manufacturers of FDA approved diagnostic antibody tests kits and Western blots for detection HIV and HTLV infections.

Project Scientist (•••••)
* Coordinated, trained, and performed troubleshooting for clinical sites for HTLV-I and HTLV-II ELISAs.

* Analyzed data for FDA PLA submission of the Dupont (Biotech) HTLV ELISAs and Cambridge Biotech HIV•••••/2 Western Blots.

* Received CBC Outstanding Achievement Award for improving the HTLV-I/II assay for sale to Wellcome (Murex) in Europe.

Senior Scientist (•••••)
* Co-developed FDA approved HIV••••• and HTLV-I/II ELISA.

* Developed software in Apple Basic for DuPont HIV••••• clinical trials and DuPont commercial kits.

* Developed HTLV-I/II antigen capture assay as the Principle Investigator on Small Business Investigational Research grant.

* Produced and characterized monoclonal and polyclonal antibodies to HTLV-I, HIV•••••, and SIV antigens and other cell surface antigens.

* Developed ELISA assays to detect HIV••••• p••••• core protein, HTLV-I/II core protein, Human Herpes Virus•••••, and Epstein-Barr virus.

The Johns Hopkins University, Baltimore, MD •••••

Research Associate in Department of Biochemistry
National Research Service Award Fellow in Environmental Health Sciences
NIH Postdoctoral Fellow Department of Biochemistry

EDUCATION

Ph.D. in Biochemistry, Iowa State University, Ames, IA
B.A. in Chemistry, Augustana College, Rock Island, IL

TRAINING

Visual Basic: Step by Step Microsoft Excel ••••• Visual Basic, a Developers Self Study Kit (self-taught)
Certificate of Achievement in Software Verification and Validation for Medical Products and Processes (3 day seminar/workshop, Logicon)
Certificate of Achievement Microsoft Outlook (one day seminar)
Advanced Leadership Training, Wood Badge (7 day seminar/workshop)
Microsoft Access ••••• Tools and Techniques (2 day seminar, Catapult, Baltimore)


COMPUTER SKILLS

Software: Microsoft: Windows •••••, Windows •••••, Windows XP
•••••Word, Excel, PowerPoint, Outlook, Project, Publisher,
•••••Excel Visual Basic, Access
Adobe: PageMaker
SmartDraw: Smart Draw Professional graphics program
Inbit: FullShot ••••• and ••••• screen capture program
JASC: PaintShop Pro •••••
Powerquest: Drive Image and PartitionMagic
Symantec: Norton System Works

Hardware: Dell and HP Brio computers
Network routers


PROFESSIONAL ASSOCIATION

American Association for Advancement of Science
Project Management Institute, Baltimore Chapter

CIVIC ASSOCIATIONS

Cofounder of Boy Scout Troop •••••, Glenwood, MD
Committee Chair Troop •••••

Key Words: Problem Solving, Multi-tasking, Detail Minded, Spreadsheet Development, Team Leader, Design Control, Flexible, Results Oriented, Takes Initiative, Adaptable, Project Leader, Follow Through, Resourcefulness, Microsoft Office, Software, Research, Diagnostic, Troubleshooting, Scientist.


ADDENDUM:
Includes ••••• publication and abstract references

Publications and Abstracts from Scientific Conference Presentations

••••• Hildesheim, A., Schiffman, M.H., Tsukui,T., Swanson, C.A., Luci III, J., Scott, D.R., Glass, A.G., Rush, B.B., Lrincz, A.T., •••••, A., Burk, R.D., Helgesen, K., Houghten, R.A., Sherman, M.E., Kurman, R.J., Berzofsky, J.A., and Kramer, T.R.: Immune activation in Cervical Neoplasia: Cross-Sectional Association between Plasma Soluble Interleukin 2 Receptor Levels and Disease. Cancer Epidemiology, Biomarkers & Prevention. 6: •••••, •••••

••••• Tsukui,T., Hildesheim,A., Schiffman, M.H., Lucci III, J., Contois, D., Lawler, P., Rush, B.B., Lrincz, A.T., •••••, A., Burk, R.D., Qu, W., Marshall, M.A., Mann, D., Carrington, M., Clerici, M., Shearer, G.M., Carbone, D.P., Scott, D.R., Houghten, R.A., and Berzofsky, J.A.: Interlukin 2 Production in Vitro by Peripheral Lymphocytes in Response to Human Papillomavirus-Derived Peptides: Correlation with Cervical Pathology. Cancer Research. •••••: •••••, •••••

••••• Tsukui, T., Schiffman, M.H., Hildesheim, A., Lucci, J., Contois, D., Lawler, P., Rush, B.B., Lrincz, A. T., •••••, A., Carbone, D.P., Scott, D.R., Houghten, R.A., and Berzofsky, J.A.: IL••••• Production by Peripheral Lymphocytes in Response to Human Papilloma Virus-Derived Peptides: Correlation with Cervical Pathology, Abstract presented at Molecular Approaches to the Control of Infectious Diseases, a conference at Cold Spring Harbor September •••••, •••••

••••• Liaw, K.L., Schiffman, M.H., Manos,M.M., Rush,B.B., Lawler, P.,Scott, D.R., Sherman, M.E., Kurman, R.J., •••••, A., Greer, C.E., Zhang, T., Glass, A.G., Lrincz, A.T.: Human Papillomavirus and Cervical Neoplasia: A Nested Incident Case-Control Study in Portland, U.S.A.: Poster presented at •••••th International Papillomavirus Conference, July •••••, •••••

••••• Hildesheim, A., Tsukui, T., Schiffman, M.H., Swanson, C.A., Lawler, P., Rush, B.B. Lrincz, A.T., •••••, A., Carbone, D., Scott, D.R., Lucci, J., Houghten, R.A., Kramer, T., Berzofsky, J.A.: T-Cell Response to HPV and Cervical Neoplasia: Results from a Cross-Sectional Study of IL••••• Production and SIL•••••R Levels Among
••••• ••••• Women With and Without SIL, Abstract presented at •••••th International Papilloma conference, July •••••, •••••

••••• Schiffman, M.H., Manos, M.M., Rush, B.B., Lawler, P., Scott, D.R., Sherman, M.E., Kurman, R.J., •••••, A., Greer, C.E., Zhang, T., Glass, A.G., Lrincz, A.T.: A Prospective Study of HPV Infection and Incident CIN, Abstract presented at •••••th International Papillomavirus Conference, October •••••, •••••

••••• Lrincz, A. ,Schiffman, M., Manos, M., •••••, A., Glass, A., and Cox, T.: Hybrid Capture(tm), A Rapid Test for Human Papillomavirus DNA, Shows Promise for Routine Clinical Use for Epidemiological Investigations. Abstract presented at 2nd International Congress of Papillomavirus in Human Pathology. April •••••, •••••

••••• Bodner, A.J., •••••, A.J., Sheets, C.J., Barr, P.Z., Sharma, H.P., and Simmons, R.L.: A Screening EIA that Detects both HTLV-I and HTLV-II Antibodies in Serum or Plasma Specimens. Presented at Second International Formosa Aids Conference, Veterans General Hospital, Taipei, Taiwan, The Republic of China, May •••••, •••••

••••• Bodner, A., Hung, C.H. •••••, A., Alexander, S., Adams-MacKie, B., Chen, W., and Rolon, N.: Detection of both HTLV-I and HTLV-II antibodies by an ELISA made with both HTLV-I viral lysate and recombinant HTLV-I env. Abstract presented at Human Retrovirology, HTLV meeting in Jamaica, •••••

••••• Kilkuskie, R.E., •••••, A.J., Lantz, D.A., and Bodner, A.J.: Combinations of AZT, Dextran sulfate, and phosphonoformate synergistically inhibit HIV••••• replication in vitro. Abstract accepted HIV Disease: Pathogenesis and Therapy, (March •••••, •••••, Grenelefe, FL). Journal of Acquired Immunodeficiency Syndrome. 4: •••••, •••••

••••• Tatematsu, H., Kilkuskie, R.E., •••••, A.J., Bodner, A.J., and Lee, K-H.: Anti-AIDS Agent 3: Inhibitory effects of colchichine derivatives on HIV replication in H9 lymphocyte cells. J. Nat. Prod. •••••: •••••, •••••

••••• Caussy, D., Levine, P.H., Pearson, G., •••••, A.J., and Bodner, A.J.: The Effect of Age on the Detection of HHV••••• Antibodies in Various Clinical States. Abstracts: •••••th International Herpes Virus Workshop, August •••••, p. •••••, •••••

••••• •••••, A.J., Levine, P.H., Pearson, G.R., Caussy, D., Tai, C.C., Youmans, M.G., Kaushal, S., Lantz, D.A., Bodner, A.J.: Development of ELISA and RIPA Assays for Detecting Antibodies to HHV••••• Abstracts: •••••th International Herpes Virus Workshop, August •••••, p. •••••, •••••

••••• Heffner-Barrett, C.L., Bodner, A.J., Alexander, S., Salahuddin, Z., Lipsky, M., •••••, A.: Monoclonal Antibodies to HTLV-I and HTLV-II GAG Proteins. Abstracts: Fifth International Conference on AIDS, June •••••, p. •••••, •••••

••••• •••••, A.J., Kilkuskie, R.E., Kaushal, I.A., Adams-MacKie, B.A., Youmans, M.G., and Bodner, A.J.: An HIV p••••• Screening Assay for Detection of HIV••••• Inhibitors. Abstracts: Fifth International Conference on AIDS, p. •••••, June •••••, •••••

••••• Bodner, A.J., •••••, A.J., Manak, M.M., Keller, G., Simek, L.L., and Ting, R.C.Y.: Comparative Sensitivity of Tests for Detection of HIV Infected Cells. Abstracts: Third International Conference on AIDS, June •••••, page •••••, •••••

••••• Bodner, A.J., •••••, A.J., Alexander, S.S., Clement, T.S., OBrien, T.A., and Frederick, W.K.: Detection of human T-cell lymphotropic virus-I (HTLV-I) antibodies by an enzyme immunoassay (EIA). Abstracts: Third International Conference on AIDS, June •••••, page •••••, •••••

••••• Alexander, S.S., Bodner, A.J., •••••, A.J., Clement, T., and Frederick, W.R.: Characterization of HTLV-III (HIV) and HTLV-I antibody reactive sera by specific western blot assays. Abstracts: Third International Conference on AIDS, June •••••, page •••••, •••••

••••• Alexander, S.S., Tai, C., Ting, R.C., •••••, A.J., Bodner, A.J. and Julien, D.W.: Western blot analysis of HTLV-III using a avidin-biotin system. Abstracts: Int. Conf. on AIDS, p. •••••, •••••

••••• Savino, W., Huang, P.C., •••••, A.J., Berrin, S., Dardenne, M: Thymic Hormone-containing cells. V. Immunohistological Detection of Metallothionein within the cells bearing thymulin (a zinc-containing hormone) in human and mouse thymuses. J. of Histochem. and Cytochem. •••••, (9): •••••, •••••

••••• Bodner, A.J., •••••, A.J., Ting, R.C.: Isolation of Monoclonal Antibodies to Surface Antigens on HTLV-III infected cells. In: Manipulations of Host Defense Mechanisms, Medica, APCS No. •••••, •••••

••••• •••••, A.J., and Huang, P.C.: A Basic Microcomputer Program for Plotting the Secondary Structure of Proteins. Computer Programs in Biomedicine. •••••: •••••, •••••

••••• •••••, A.J., and Huang, P.C.: Cellular Uptake of Cd and Zn. Biol. Trace Element Research. 3: •••••, •••••

••••• Huang, P.C. and •••••, A.J., et al.: Cadmium Resistance in CHO Mutants. Federation Proceedings. •••••: •••••, •••••

••••• •••••, A.J,. and Robyt, J.F.,: Nature of Fructan of Streptococcus mutans OMZ ••••• Infection and Immunity. •••••: •••••, •••••

••••• Robyt, J. F. and •••••, A.J.: The mechanism of Dextrasucrase Action: Activation of Dextransucrase from Streptococcus mutans OMZ ••••• by Dextran and Modified Dextran and the Nonexistence of the Primer Requirement for the Synthesis of Dextran. Arch Biochem. Biophys. •••••:•••••, •••••

••••• •••••, A J., and Robyt, J.F.: Activation of Dextransucrase from Streptococcus mutans OMZ ••••• by Dextran and Modified Dextran and the Nonexistence of the Primer Requirement for the Synthesis of Dextran. Federation Proceedings. •••••: •••••, •••••

••••• Sandford, P.O., Nafziger, A J., and Jeanes, A.: Reaction of Sodium Hypochlorite with Amines and Amides, A New Method for Quantitating Polysaccharides Containing Hexosamines. Analytical Biochemistry. •••••: •••••, •••••

••••• Sandford, P.O., Nafziger, A J., and Jeanes, A.: Reaction of Sodium Hypochlorite with Amines and Amides, A New Method for Quantitating Amino Sugars in Monomeric Form, Analytical Biochemistry. •••••: •••••, •••••