James Klein, PhD Merck & Co., Inc.

Jim Klein is Associate Vice President of the Global Technical Operations – Sterile & Validation Center of Excellence at Merck & Co, Inc.  He has over 20 years of experience in pharmaceutical development and manufacturing.  He has worked in a variety of roles including technical operations, process and analytical development, and regulatory affairs.  Areas of expertise include process validation, sterile/aseptic operations, and quality systems.  His current responsibilities include technical oversight and support for sterile/aseptic technical operations globally.