Seshagiri B

Biography

Senior Scientist - Formulation Development Company Name Aspen Pharmacare Dates Employed Nov 2011 – Present Employment Duration 5 yrs 11 mos Location Hyderabad area, india  Accomplished responsibility and lead the formulation development team for development of various solid & Liquid dosage forms for Europe, Australia, Brazil, Mexico, South Africa and Venezuela markets.  Project evaluation, designing and implementing formulation strategies.  Accountable for literature search and patent infringement analysis.  Managing various activities like procurement of API, excipients and specific equipment’s for the developmental activities.  Procurement, handling and evaluation of reference samples from various markets.  Co-ordinating with various departments like Purchase, Analytical, Production, Regulatory Affairs, Quality Assurance, Quality Control and API manufacturing personnel etc. for the completion of the projects within the time lines.  Planning and organizing day to day research activities and resolving procedural problems.  Pre-formulation studies and evaluating physico-chemical compatibility of drug substances with other ingredients.  Selection of batches and preparation of stability protocols as per ICH guidelines. Interpretation of stability data and scientific approach for resolving stability related issues.  Gearing the activities for documentation of Master Product Document, raw material and finished product specifications for various regulatory markets and harmonized with the official monographs.  Adept at transferring of technology from lab scale to Pilot and Pivotal scales.  Execution of Pivotal/Exhibit batches for submission to variousregulatory agencies like UK MHRA, TGA, ANVISA, COFEPRIS and MCC.  Trouble shooting of pharmaceutical dosage forms at production floor.  Preparation of stage wise Product Development Reports and providing necessary data/documents for Regulatory filings and answering the Regulatory queries.  Deftly responsible for improving the existing products with respect to product quality & cost relation   Formulation Research Associate - IV Company Name Aurobindo Pharma Dates Employed May 2006 – Oct 2011 Employment Duration 5 yrs 6 mos Location Hyderabad, India During my association with Aurobindo Pharma , I have acquired widespread exposure in the following areas: • Project evaluation, designing and implementing formulation strategies for development of generic drug products. • Literature search & Preparation of Literature Survey Report. • Managing various activities like procurement of API, excipients and equipments for the developmental activities. • Co-ordinating with various departments like Purchase, Analytical, Production, Regulatory Affairs, Quality Assurance, Quality Control and API manufacturing personnel etc. • Pre-formulation studies and evaluating chemical compatibility of drug substances with other ingredients. • Planning and organizing day to day research activities and resolving procedural problems. • Execution of experimental work and Optimization of Oral dosage form like IR and ER tablets, Capsules and Dry powder for Suspension for US and EU markets. . • Selection of batches and preparation of stability protocols as per ICH guidelines. Interpretation of stability data and scientific approach for resolving stability related issues. • Preparation of raw material and finished product specifications for various regulatory markets and harmonized with the official monographs. • Knowledge of Scale up and technology transfer of formulations to Pilot and Pivotal scales. . • Execution of Pivotal/Exhibit batches for submission to various regulatory agencies like US FDA and UK MHRA. • Trouble shooting of pharmaceutical dosage forms at production floor. • Preparation of stage wise Product Development Reports providing necessary data/documents for Regulatory filings and answering the Regulatory queries.

Research Interest

 Pharmaceutical Science