Bharath Kumar Gowdampally

Background

About Bharath Kumar Gowdampally

Formulation scientist with strong background in pre-formulation, formulation, and process development areas. Experience in development of solid orals from concept through to validation of commercial manufacture for NDA and ANDA submissions. Experience in manufacturing pre-clinical and clinical trial materials in cGMP environment. Expert in determining suitable drug carriers for non-invasive routes like pulmonary delivery. Capable of performing pre-formulation studies including excipient compatibility, stability, and physico-chemical characterization of pharmaceuticals.• Carry out various unit operations for the development of solid orals including sieving, blending, dry granulation, high and low shear wet granulation, drying, milling, tablet compression, tablet coating, bead coating, extrusion-speronization, and encapsulation• Formulation and process development of IR and MR tablets and capsules for NDA and ANDA submissions• Manufacture Clinical Phase Registration, and Validation batches in cGMP environment• Design and perform excipient compatibility and stability studies using various thermal and spectroscopic techniques• Draft and review Master Batch Records, SOPs, Protocols. and technical reports• Train manufacturing personnel in cGMP environment• Efficient collaborator across cross-functional teams (QC, QA, Manufacturing, and Inventory)• Perform In-process inspections on blends (flowability, compressibility, PSD, moisture content) and tablets (weight, hardness, thickness, friability, disintegration)• Knowledge on QbD, DOE, and pharmaceutical development reports for regulatory submission• Characterize polymeric particles for charge, size, and surface chemical groups using spectroscopic and microscopic techniques