Pharmaceutical and Biopharmaceutical Product Development and Validation Chemist

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