Validation and Regulatory Pharmaceutical Consultant

Pharmaceutical Consultant: Protein Analysis, Validation and Regulatory Compliance (1431)

Developing and validating standard and state of the art analytical methods to characterize pharmaceuticals and biopharmaceuticals. ~Expert in liquid and gas chromatography, capillary electrophoresis, spectrophotometry and mass spectrometry (single and triple quad and MALDI and ion - trap).
Developing and validation of biological activity determination procedures, including enzyme linked immuno - assays (ELISA) and cell based activity assays to support bioequivalence requirements.
Proteins and peptides characterization such as amino acid analysis, sequencing and mass spectrometry (MALDI and ESI).
Proteins and peptides spectral characterization wtih FTIR, fluorescence, CD and NMR, light scattering, differential scanning calorimetry and analytical ultracentrifugation.
Audit and compliance experience related to analytical methods and instruments used to support validation, comparability and bio equivalence, including sterile and non - sterile pharmaceutical manufacturing operations.
Experience in providing FDA mandated review of documents related to analytical methods and instruments supporting manufacturing and bioequivalence studies.
Purification process development and characterization of proteins, monoclonal antibodies, glycoproteins and oligosaccharides and synthesis and analysis of peptides.

Independent Consultant, 2000 - Present

Review of analytical documents to be included in CMC sections of NDA, ANDA, and BLA filings.
Operational effectiveness of quality operations.
Provided FDA mandated review of analytical documents related to the manufacture of vaccines (polysaccharide and conjugated polysaccharide), traditional pharmaceuticals, and conjugated monoclonal antibodies.
Involved in FDA mandated expert review of analytical documents dealing with PK/PD studies used to support bioequivalence studies as part of ANDA filings.
Carried out analytical compliance audits of European facilities involved in sterile and non-sterile manufacturing.
Member of a multidisciplinary team involved in improving the operational efficiency of manufacturing sites.
Served as Acting Director of Analytical Laboratory involved in contract testing laboratory involved in regulatory compliant testing of bio-pharmaceuticals, pharmaceuticals and packaging materials.

ViroMed Laboratories, Camden, NJ, Analytical Division, 1998 - 2000

Setup an analytical division involved in providing cGMP/GLP compliant characterization for formulations and testing related to bio pharmaceuticals (proteins, monoclonal antibodies, glycoproteins and peptides).
Stability and package integrity testing of medical devices and pharmaceuticals.
Developed LC-MS methods to detect serum and urine levels of leachates derived from medical devices, such as drug coated stents, implanted in animals during toxicology testing.

MA BioServices, Rockville, MD, Division Director, 1994 - 1998

Established analytical and bioanalytical division that was involved in cGMP/GLP compliant characterization, formulations development and stability testing for biopharmaceuticals (proteins, glycoproteins, peptides, oligosaccharides and oligonucleotides).
Provided analytical and bioanalytical support for toxicology studies of materials under the Federal National Toxicology Program.

DuPont & DuPont Merck Pharmaceutical Company, Senior Research Scientist, Biotechnology Division, Wilmington, DE, 1988 - 1994

Developed scaleable protocols for purification and renaturation of recombinant proteins from E.coli, mammalian cells, baculovirus and natural sources, and provided protein and glycoprotein chemistry expertise for research projects.
Provided protein characterization support for GMP processes using a variety of techniques like Amino Acid Analyses, N- and C- Terminal sequencing, peptide mapping, analytical and microbore HPLC, capillary zone electrophoresis and laser desorption mass spectrometry.
Supplied custom synthesized peptides (which had been characterized by amino acid analyses, HPLC and mass spectrometry).
Coordinated the characterization and purity assessment of proteins, and maintained close contact with researchers involved in scale up of purification.
Interacted with scientists involved in gene cloning and expression, and secondary, tertiary and quaternary structural studies using crystallography, analytical ultracentrifugation and microcalorimetry, and spectral techniques like NMR, CD and fluorescence spectroscopy.

Monsanto Company, Senior Research Scientist, 1984-1988
Rockefeller University, New York, NY, Research Associate, 1982-1984