Senior Pharmaceutical Quality and Compliance Leader with tactical and advisory experience in branded/generic solid dosage, analytical method development, validation, and process validation. History of demonstrating critical leadership in national and international technology transfers for clients in India and the US, residual solvent FDA compliance project for marketed products to demonstrate safety with savings of $1M. Thought leader and strategic executor in multiple pharmaceutical functions as technical lead who offers a longstanding record of achievement in establishing cGMP compliance, QC lab operation, QC technical services, and pharmaceutical cleaning method worst case scenarios.Research experience in multiple scientific disciplines including serotonin evaluation for antidepressant clinical trials, Immunochemistry, lipid biochemistry-production and metabolism of bioactive lipids (prostaglandins and thromboxane) and Platelet Activating Factor (PAF) by human platelets and endothelial cells and synthetic organic chemistry. .Publication in scientific journals and books. Invited article in Methods in Enzymology. Recipient of New Investigator Research Grant Award from National Institute of Health, Bethesda, MD.Specialties: Pharmaceutical Quality Control, technology transfers, innovative analytical method development, cleaning method worst case scenarios, particle size method development, Bio analytical method validation, stability management.Instrumental analytical techniques (GC, HPLC-UV, HPLC-EC, HPLC-fluorometric detectors), NMR and MS. HPLC-Bioassay (platelet aggregation) for thrombotic agents.Platelet Shape Change Assay- known physiological model for the central serotonergic receptor.Serotonin uptake studies.HPLC-Specific antibodies-Immuno chromatography for in vivo hormone evaluation.Solid phase RIA.
Listed skills include Uv, Gas Chromatography, Analytical Methods Development, Chemistry, and 31 others.
