Profile: Jeff Odum

Jeff Odum has been involved in the biopharmaceutical industry for more than 25 years.  He is a nationally recognized author and speaker who provides industry insight in the areas of regulatory compliance, facilities and process design, and project management for biopharmaceutical companies.  These companies develop facilities that are focused on the development and manufacturing of regulated products for the consumer industry.

Jeff is a Technical Advisor to the International Society of Pharmaceutical Engineering’s (ISPE) North American Education Committee – the body that develops and executes international training programs for the biopharmaceutical industry.  He is also a member of ISPE’s Technical Training Staff.  In this role, he leads several professional industry training courses, nationally and internationally, that are focused on engineering, facility design, and regulatory compliance curricula.  In 2002, Jeff received the Society’s prestigious Richard B. Purdy Award for Outstanding Achievement within the biopharmaceutical industry.

His academic initiatives include facility projects that have focused on training students in both laboratory and large scale process unit operations for James Madison University and North Carolina State University.  He was also the founder and past Director of the Validation Academy, an instructional unit of the BioNetwork Program for the North Carolina Community College System.  He has developed course curriculum for numerous training and instructional courses, focused on the biopharmaceutical industry and has taught courses on GMP compliance and facility design in the United States and ten other countries across the globe.

Jeff’s experience in the biopharmaceutical industry has included design and construction of many of the industry’s major manufacturing projects, as well as consulting roles for a number of the global biotechnology industry leaders.  These projects represent a total capital investment of well over $2 billion dollars and produce many of the key biopharmaceutical therapeutics and vaccines currently in the global marketplace.  He has also provided global training for companies such as Astra Zeneca, Abbott, IBM, Novartis, Emergent, Eli Lilly, WL Gore and Merial.  He has also provided training for Health Canada.

Jeff is the author of more than 30 published works on many critical issues, including process improvement and execution to meet regulatory guidelines issued by the FDA and other international regulatory bodies.  These works include five books that are recognized industry reference guides, including Sterile Product Facility Design and Project Management (CRC Press).  He was also one of the lead chapter authors for the Baseline Pharmaceutical Engineering Guide for Biopharmaceutical Manufacturing Facilities and is currently one of the Task Team Leaders for the in-development Bioprocess Product and Process Baseline Guide that is scheduled for publication in 2009.

Jeff graduated from Tennessee Technological University with a degree in Mechanical Engineering and received his Masters Degree in Engineering from the University of Tennessee-Knoxville.