Pradeep Phalke

Background

About Pradeep Phalke

A Business Unit leader in pharmaceutical industry with 24+ years of experience in the leading global companies with increasing responsibilities. I have expertise in the area of Analytical Strategies Development and Implementation for NCEs and Lifecycle Management of Drug Products. Working and collaborating in diverse global environment, key member of Senior Leadership Team. Since Dec 2020, I am leading Analytical Development & E GMP Quality Control unit at Syngene International Ltd. serving global customers. As a BU Head, I am focusing on topline business growth, building development strategy for the group and leading a group of 300 + scientist who are delivering integrated drug development projects globally. Prior to this role, I worked for Johnson & Johnson ( Janssen R&D) for 11 years. My last role was Scientific Director and was a member of global leadership team. Specialization - Method Development, Validation, Stability studies and Tech Transfer activities related to Drug Substances and Drug Products - Well versed with cGMP and ICH/Regulatory requirements ( mainly USFDA,EMEA, Asia, Latin America)- Design Technology Strategy Master Plan in order to strengthen the technical capabilities, meet the changing regulatory expectations and providing solutions for analytical challenges associated with wide range of therapeutic area portfolio- Talent Acquisition,Talent Development, Driving Change management - Process Excellence through implementation of Lean Concepts - Driving and Practicing Diversity and Inclusion principles towards building successful organization - Technical and People leadership - Contributing to influence the evolving regulatory landscape by providing review comments for new guidelines and setting up of best practices