Pharmaceutical and Biopharmaceutical Product Development and Validation Chemist
Technical Consultant #1906
- 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)
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
- Senior Postdoctoral Fellow, Weizmann Institute of Science, Israel
- Fellow of Royal Chemical Society
- 50-Year Honorary Member of American Chemical Society
- Hebrew (conversational)
- German (conversational)
Academic and Professional Affiliations
- American Chemical Society
- Sigma Xi
- Royal Chemical Society
- Massachusetts Separations Society
- Greater Boston MS Discussion Group
- 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
- 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