Jeff Odum has extensive experience in the biopharmaceutical industry and has been involved in the development and delivery of some of the industry’s major manufacturing projects.
He consults on strategic planning and facility design/OEX as well as risk assessment, compliance auditing, and regulatory review. Jeff has assisted companies in developing regulatory submissions and provided review of licensing packages for new and renovated manufacturing facilities.
Jeff Odum holds a Master in Engineering and the CPIP certification as a Certified Pharmaceutical Industry Professional. He is a frequent lecturer and instructor to global companies, and is the author of more than 80 published works on critical industry issues, including process improvement and execution to meet regulatory guidelines issued by the FDA and other international regulatory bodies. His most recent publication is “Biopharmaceutical Manufacturing Facilities: Implementing Process Architecture in Programming and Facility Design” for Wiley & Sons. He is a Teaching Fellow at NC State University, a SME/Technical Trainer for PDA and ISPE, and recipient of the Richard Purdy Award for outstanding achievement from ISPE.
“Passing on my experience and knowledge is what drives me every day.”
What's your view on the industry?
"The drivers for improvements in manufacturing: efficiency, flexibility and utilisation, create numerous opportunities and challenges for companies developing and manufacturing drug products. But with change comes risk. Identification of risk and providing cost-effective solutions in facility design is key to success in defining feasibility of a manufacturing approach or project delivery platform."
Why work in the industry?
"There is no greater feeling than having a stranger come up to you and say “thank you for helping to save my life." I have had that happen. I will never forget that; it drives you in a way that is hard to describe… but one you always see as your mission to the patient. Passing on my experience and knowledge is what drives me every day at NNE. I like to think that this value is important to our customers."
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