Practice Leader: ATMPs & Biologics
Jeff Odum’s career encompasses over 30 years of experience in the development, execution, delivery, and management of facility and operational programs in the biotechnology and pharmaceutical industries. During his career, he has been involved in leading and managing strategic planning, feasibility and conceptual planning/design, design, construction, start-up, and validation support, in addition to participating in the development and presentation of licensing packages to the FDA. Specific responsibilities have included positions as Global Lead, Operations Director, Design Manager, Facility/Engineering Manager, Owner’s Representative, Program Manager, and Construction Site Manager for projects focused on the manufacture of human therapeutics including vaccines, cancer therapeutics, generics, and ATMPs. These efforts ranged in size from $1 million to more than $2 billion in total program costs.
Jeff was the North American Education Advisor to ISPE, where he also is currently the Chair of the Global Biotechnology Community of Practice and the Project Lead for the ATMP Guide for Autologous Cell Therapy Products, co-Lead for the new revision of the Biotech Manufacturing Facilities Baseline Guide, chapter author for the Biotech Product and Process Development Baseline Guide, and a lead author for the BPOG Closed Systems Closure Playbook. He has written over 50 Technical articles and published four Industry reference books.
He is a member of the BTEC teaching faculty in NC State University’s Gradute program in Biomanufacturing.