BIKASH CHATTERJEE

He has been involved in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years.

Mr. Chatterjee has guided the successful approval of over a dozen new products within the U.S. and Europe and is a frequent speaker at industry and regulatory events. He has published and is a regular editorial contributor to several internationally recognized industry journals. Mr. Chatterjee has spoken and published extensively on the application of PAT, Lean Six Sigma, Quality by Design and Process Validation approaches within the regulated life sciences industry.

He is an ISO 9000 certified Lead Assessor and Six Sigma and Lean Manufacturing Master Black Belt. Mr. Chatterjee has developed and transferred products and processes to satellite operations and Contract Manufacturing Organizations for much of his career. He has extensive experience with design and implementation of systems to satisfy the requirements for ICH Q8, Q9, and Q10 as well as e-pedigree and the application of risk based approaches in the area of validation. His experience in complex product and process development and technology transfer has resulted in the development of a six sigma based methodology to support the PAT initiative and has successfully tailored the principles of Lean and Six Sigma for application in the pharmaceutical R&D environment resulting in reduced program risk and reduced time to market.

Mr. Chatterjee is a member of the USP National Advisory Board and is the Past-Chairman of the Golden Gate Chapter of the American Society of Quality. Mr. Chatterjee is a member of the Healthcare Information and Management System Society Technical Advisory Board and sits on several private Scientific Advisory Boards. He is a standing member of the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology,  a founding member of the CPhl Expert industry Advisory Board and writes a recurring column for several magazines on industry trends and challenges. He is a frequent industry speaker and has published over 70 articles.  He is also the author of “Applying Lean Six Sigma in the Pharmaceutical Industry (ISBN: 978-0-566-09204-6), July 2014 published by Gower Publishing,

Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego.