Pharmaceutical and Biopharmaceutical Product Development and Validation Chemist

Technical Consultant #1906


Expertise

  • Analytical chemistry and biochemistry.
  • Analytical biotechnology and biopharmaceutical regulatory science.
  • Analytical method development and validation.
  • Separations science and mass spectrometry.
  • Thermal stability studies of immunoglobulins.
  • Separation and quantitation of monoclonal antibodies in cell growth.
  • Validation of chromatographic methods.
  • Derivatization approaches for a fermentation derived, cyclic peptide analog.
  • HPLC - High Performance Liquid Chromatography
  • UPLC - Ultra Performance Liquid Chromatography
  • GC - Gas Chromatography or General Chromatographer
  • SFC - Supercritical Fluid Chromatography
  • FFF - Field-Flow Fractionation
  • SDS-PAGE - Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis
  • SDS-IEF - Isoelectric focusing
  • MS - Mass Spectroscopy
  • FTIR - Fourier Transform Spectroscopy
  • Raman spectroscopy, vibrational, rotational, and other low-frequency modes.

Expert Witness Experience

  • Analysis of Trace Metal Ions in Reactor Cooling Waters
  • Proprietary vs generic drug manufacturer - litigation
  • HPCE Case,(DNA Instrumentation Development)

Experience

Independent Consultant, 1983 - 2009

  • Served numerous Fortune 200 clients, including the FDA providing various technical consulting expertise.

Northeastern University, Boston, MA, Associate Professor of Chemistry, 1979 - 2008

  • University teaching at undergraduate and graduate levels, directing basic and applied research and development in a graduate student, Postdoctoral Fellow and Visiting Scientist situation.
  • Research and development involved in analytical chemistry, analytical biochemistry, and analytical biotechnology areas.

Thermo Electron Corporation, Waltham, MA, Senior Scientist, 1977 - 1979

  • Group leader involved in areas of analytical chemistry for N-nitrosamine analyses in various matrices, including animals, drugs, foods, environmental samples, and others.
  • Responsible for writing original research and development proposals for external funding, manuscripts for publication in peer-reviewed, scientific journals, magazines, and books.

Boyce Thompson Institute for Plant Research, Yonkers, NY, Senior Scientist, 1973 - 1975

  • Laboratory research and development in areas of analytical chemistry of synthetic anti-malarial drugs.
  • Analytical research and development insect pheromones, identification of natural products.

Honors & Publications

Credentials

  • Senior Postdoctoral Fellow, Weizmann Institute of Science, Israel
  • Fellow of Royal Chemical Society
  • 50-Year Honorary Member of American Chemical Society

Languages

  • Hebrew (conversational)
  • German (conversational)

Academic and Professional Affiliations

  • American Chemical Society
  • Sigma Xi
  • Royal Chemical Society
  • Massachusetts Separations Society
  • Greater Boston MS Discussion Group

Awards

  • Numerous research awards and certificates for lectures presented.

Publications and Patents

  • Over 300 scientific papers, reviews, books, (over 500 formal scientific presentations and posters.
  • Over 50 editorial reviewed columns in professional magazines

Education

  • Ph.D. Organic Chemistry, New York University, New York, NY
  • M.S. Organic Chemistry, New York University, New York, NY
  • B.S. Chemistry, City College of New York, New York, NY
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