Hann-Ping Wang, PhD

Hann Ping Wang, PhD

Sr. Quality Scientist/Certified Quality Auditor

Dr. Hann-Ping Wang is a PhD biochemist from Wayne State University with over 30years’ experience in Quality and Regulatory Compliance, and Product Development in the Medical Devices, IVD, Pharmaceutical and Biotech industries. He is an ASQ-Certified Quality Auditor.

Dr. Wang’s solid, working,experience-base includes:

  • FDA registration
  • ISO900
  • 510(k), PMA
  • CE certification
  • CLIA
  • cGMP
  • Development of one-step and platform-based immunoassays
  • Technical marketing communication 
  • AutomationCapillary and gel electrophoresis
  • Enzyme kinetics
  • Affinity chromatography
  • Isoelectric focusing
  • HPLC
  • Protein purification, conjugation and radiolabeling

Dr. Wang’s development involvement has won him seven FDA 510(k)s in the one-step test product line, six U.S. and European patents in capillary electrophoresis, and a U.S. patent in multi-analyte, time-resolved fluorescence immunoassay.

EXPERIENCE:

Co-founder Excel Scientific, Inc. Yorba Linda, CA

  • Developed one-step lateral flow immunochromatographic assays.
  • Developed domestic and overseas markets for diagnostic products\
  • Managed daily operation of the company, which is registered to the FDA and State Health Department as a medical device establishment.
  • Received seven FDA 510 (k)s
  • Organized exhibits at the 1998 Medica Trade Show in Dusseldorf, Germany.

Project Manager/Senior Staff Scientist, Beckman Instruments, Brea, CA

  • Directed R&D activities in the clinical application of capillary electrophoresis
  • Directed assay development for an automated immunoanalyzer
  • Managed R&D and technical support activities
  • Managed technical collaboration between external researchers/ clinicians
  • Coordinated inter-departmental collaborations
  • Assisted Marketing in the promotion of new technology/products
  • Awarded 6 U.S. patents and 6 European patents in Capillary Electrophoresis

R&D Director, Chimerix Corporation, Glastonbury, CT

  • Established an 8,000 square feet R&D facility and built a project team consisting of 7 scientists
  • Established the company’s basic technology in multi-analyte time-resolved fluorescence immunoassay
  • Provided the Board of Directors with information and definition of R&D goals for the company
  • Design and development of a fully automated immunoassay system
  • Awarded a U.S. patent in multi-analyte time-resolved fluorescence immunoassay

R&D manager, Kallestad Diagnostics, Chaska, MN

  • Directed development of immunoassay kits including RIA, IRMA, EIA and IEMA
  • Participated in corporate strategic planning of new products
  • Interacted with manufacturing, Quality Control, and Marketing to ensure a smooth market release
  • Coordinated compilation of product performance data for FDA 510(k) submissions

R&D Group Leader, E.I. duPontdeNemours& Co., Billerica, MA

  • Directed and managed development of over fifty I-125 labeled compounds as research products
  • Proposed and developed RIA and EIA kits
  • Transferred technology to the Manufacturing

EDUCATION:

Ph.D. Biochemistry, Wayne State University, Detroit, MI

B.S. Food Science, Chung-Hsing University, Taiwan

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