Somanath Dev

Background

About Somanath Dev

Proven track record directing Quality Control Laboratory, Analytical R&D Laboratory, raw material, stability, and microbiology testing (USP, Endotoxin, and laboratories. USP, Sterility testing, Microbial count, and Environmental Monitoring.•Worked on drug substance (API), drug products like Solid (Tablet, Capsule, and Soft Gel), Semisolid (Ointment and Cream), liquid, suspension, Nasal Spray and different types of parenteral sterile Injectable dosage products including the Controlled drugs (Schedule II to V) and Biological products, like Protein, Cholesterol, Amino acid, and peptide.•Experienced in analytical method development and validation of drug substances, API (Active Pharmaceutical Ingredients), prescription (solid, semisolid, liquid, and suspension), OTC, and controlled drugs, validation of stability indicating method, solution stability studies and also cleaning validation of the drug residue and the detergents.• Skilled in writing the validation and method transfer protocols, reviewing the test results, validation report, OOS, OOT, Root Cause Analysis, and Change Control. LIR investigation reports. Trend Analysis of all the Analytical Data and the Annual Product Report.• Extensive experience in cGMP/c, GLP, cGDP, OSHA, EPA, and DEA regulations, 305B Compounding pharmacy regulations, USP/NF methods of analyses, FDA and ICH guidelines, and a broad understanding of quality control principles. Also experienced in analytical methodologies of USP, JP, BP, and EP; and IQ, OQ, and PQ of the instruments and the preventive maintenance of the instruments.• Experienced in overseeing the laboratory operations, including OOS, OOT investigations, NCR, LIR, CAPA deviations, method development, validation, method transfer, and troubleshooting, reviewing the SOP, and CMC submissions. Also experienced in handling multiple projects simultaneously.• Interacted with the FDA, Quality Assurance, Regulatory, and Quality, and responded to FDA 483 Warning letters and FDA deficiency letters to get approval of the ANDA submission.• Worked with Regulatory, Quality, Quality Assurance, and the Production groups.• Experienced in operation and troubleshooting of HPLC, UPLC, GC, UV-vis, Dissolution Instrument, Flame Photometer, FT-IR, Karl Fischer, Near-IR, TGA, PXRD, GC-MS, and LC-MS.• Proven records of initiative and achievement-numerous methods and published several papers in international journals, resulting from research works. Supervised BS, MS, and Ph.D. level chemists.