Sanjay Jain
Associate Engineering Director, Combination Product - Drug Delivery Device @Johnson & Johnson Innovative Medicine
Signup · Get unlimited contacts
WORK HISTORY
Associate Engineering Director, Combination Product - Drug Delivery Device @Johnson & Johnson Innovative Medicine
Developing Strategies & Leading Execution plan for Patient Convenient Drug Delivery Systems.Emphasis on Technology Exploration and Feasibility to meet current and future unmet needs.Leading multiple ‘end to end’ device team (product & portfolio strategy, patient & commercial insights, technology exploration, product development, Human Factors & Usability, Product launch and CMO technical services for devices) across many drug modalities (Small Molecules, Biologics, Gene Therapy)Product portfolio includes:Parenteral Injections – Manual and Auto injections systems, High Volume and High Viscosities, Wearable Drug Delivery SystemsRetinal Delivery – Suprachoroidal Delivery, Sub-Retinal Injections, Intravitreal Injections deliveryDrug Delivery to Inner EarIntradermal Drug DeliveryManager – Quality Systems and Validation – Feb 2006 to Nov 2008 Therakos, Inc (A Johnson & Johnson Co) – Exton, PA Developed and executed quaity strategies for design and development of new medical devices.Excellent understanding of ISO13485, FDA QSR, Risk Management and Design Control procedures.Certified Quality Manager, Quality Engineer and Quality Auditor (ASQ).Certified Six Sigma Black Belt.Well versed with various Quality Tools.Senior Quality Systems Engineer – August 1998 to Feb 2006 Medex Inc – Southington, CT (formerly part of Ethicon Endo-Surgery, a division of Johnson & Johnson) Provide Quality Engineering support to Vascular Access division to ensure that products are designed, developed, and manufactured in accordance with customer requirements, plus corporate and regulatory requirements. Design and implement Standard Operating Procedures to ensure clear interpretation of regulatory requirements.Formulate innovative and statistically valid sampling plan to ensure adequate producer / consumer protection.Developed and executed Equipment, Process, Product and Software Validation.Design and validate test methods using Measurement System Analysis.
EDUCATION
Temple University School of Pharmacy
Certificate Course - Drug Development
Manipal Institute of Technology
BS, Mechanical Engineering
California State University, Fullerton
MS, Mechanical Engineering
ABOUT SANJAY JAIN
Developing Strategies & Leading Execution plans for Patient Convenient Drug Delivery systems. Leading ‘end to end’ Combination Product Development Teams.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.