Vinayak Kokate

Assistant Manager @Rubicon Research Limited

Thane, IN

Formulation development team of Scientists; Project Tracking and coordination (Technical) for New Product Development for US and Europe Market Responsible for Site Transfer of Products; Project management of Global Contract Manufacturing Projects; Coordinating with procurement, Analytical, Costing, Marketing, Production for both New Products and Site Transfer; Budgeting and Budgetary control.Development and evaluation of solid oral products for US and Europe market• ANDA fillings for US market : designing 505 (b) 2 opportunity, Para IV fillings for US market• Expertise in Design, plan and perform scientific experiments for all solid oral dosage forms such as Literature search, Patenting strategics, Pre- formulation study, Prototype development lab and stability, process optimization, scale-up operations & Pre Exhibit Batch at the shop floor and execution of all processes as per the US FDA, ICH, GMP/GLP guidelines• Finalized in-process and finished product specifications• Tie ups with suitable CRO’s for carrying out formulation characterization, preclinical studies, clinical studies and commercial manufacturingProvide efficient and robust processes/methods/ design for the manufacture of the various products

R.C.Patel Institute of Pharmaceutical Education & Research, Shirpur Dist- Dhule.

Master of Pharmacy

s.v.p.m's college of pharmacy, Baramati, pune.

Bachelor of Pharmacy (B.Pharm.)