Nilesh B.

About Nilesh B.

22 years of dedicated work in formulation development for regulated market. Strategizing and developing commercially feasible formulations for all regulated markets. BA/ BE data interpretation, Quick evaluater of relevant product literature/Patent to finalize appropriate formulation strategy. Experience in scaling up of complex products with excellent analytical and trouble shooting abilities. Filed & commercialized multiple generic products. Very well aware about the expectations of various agencies. Filed more than 15 patents. High ability to understand process issues impacting Product CQAs. troubleshoot issues quickly by putting proper controls in process. Expert in multiple formulation techniques viz melt extrusion, drug layering, liquid capsule filling, soft gels, functional coating, dyno milling, spray drying. Believes in resolving process issues quickly. Basic knowledge, relevant reading, keen observation can resolve any problem. Expert to build a strong team, guide them, motivate them to maximize efficiency. Through knowledge of areas to work in reduction of product costing.

Experience

1. Associate Vice President

   Aurobindo Pharma Ltd

   Dec 2019 — Present · Hyderabad, IN

   Handled team of formulators/supporting analysts. Budgeting. Responsible for 9-12 ANDA filings per year. Same products will be extended to various other markets as EU, Canada, China, ROW etc. High exposure to new product evaluation, strategy finalization, interpretation, building quality systems in department. Monitoring outsourced product development. Taking decision on finalization of composition and process after 360 degree evaluation of all trials in complex formulations. Running sucessfully…

Education

• College of Pharmacy Nashik (NDMVP)

  M. Pharma (Pharmaceutics)

• College of Pharmacy Nasik

  M Pharma