Genesis AEC Names Jeffrey Odum, CPIP,
Practice Leader, ATMPs and Biologics
Jeffrey Odum joins Genesis AEC with 25+ years of experience in the biopharmaceutical industry which has included the development and delivery of many of the industry’s major manufacturing projects, consulting roles in compliance and strategic planning, and development of many of the industry’s key reference and guidance documents. These projects represent a global capital investment of more than $3B and the production of many of the key biopharmaceutical therapeutics and vaccines licensed today.
As a Certified Pharmaceutical Industry Professional (CPIP), he has assisted companies in developing strategic concepts for manufacturing assets, led design and construction programs, and supported regulatory submissions and provided consultant review of licensing packages for new and renovated manufacturing facilities.
A recognized expert in biopharmaceutical manufacturing, Jeff has authored 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. These works include four books that are recognized industry reference guides, including Process Architecture in Biomanufacturing Facility Design (Wiley & Sons) and Sterile Product Facility Design and Project Management (CRC Press). His publication contributions also include the Pharmaceutical Engineering Guide for Biopharmaceutical Manufacturing Facilities, the Project Management Good Practice Guide, Baseline Process Engineering Guide for Biotech Product and Process Development, and the newly released guidance for ATMP Process and Facility Design.
As a member of the ISPE and PDA Technical Training Faculties, he has taught courses in 15 countries to over 1,200 individuals, including regulators in the US, Canada, China, and Mexico. Jeff also serves as a Teaching Fellow in the Biomanufacturing Graduate Program of NC State University’s Biomanufacturing Training and Education Center (BTEC) and as the current Chair of the ISPE Biotechnology Global Community of Practice. He holds his master’s degree in engineering from the University of Tennessee.
- About the Author
- Latest Posts
BioBuzz is a community led, experience focused, biotech and life sciences media and events company. BioBuzz highlights regional breaking news, industry professionals, jobs, events, and resources for business and career growth. Their weekly newsletter is subscribed to by thousands in the BioHealth Capital Region and Greater Philadelphia as the go-to for industry updates.
