Amit Khanolkar

Senior Director, Combination Product & Device @The Janssen Pharmaceutical Companies Of Johnson & Johnson

Global Leader with End-to-End ownership of Drug Delivery Systems for the entire portfolio of Janssen products (Large Molecules, Small Molecules, Vaccines). Responsibilities include supporting External Asset/Partner Evaluation/ Due Diligence, New Product Development. New Product Introduction, Lifecycle Management, Quality Engineering, Demonstrated ability to lead large diverse teams across geographies and work collaboratively with global internal and external partners. Lead & own the Combination Product Development Focus Area within Janssen, a cross-functional SME group that provides governance and oversight to product teams on Design & Development, Manufacturing Process Development, Design Control, Human Factors, Risk Management & Reliability Quality Engineering. Proven experience in direct interfacing with global Health Authorities for Pre- and Post-Market Regulatory submissions and implementation of New Regulations including 21 CFR Part 4, EU-MDR etc.