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Jeff Odum

Global Technology Partner, Strategic Manufacturing Concept Group

What's your view on the industry?

"We get one chance to make the right first impression. The results of a well-executed conceptual study will bring operational benefits to our customers for decades. 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 do you work in this business?

"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 the feeling; it drives you in a way that is hard to describe… but one you always see as your mission to the patient.

I have had the good fortune to be involved in over $2 billion of capital projects for human therapeutics. As a Certified Pharmaceutical Industry Professional, Teaching Fellow at NC State University, SME/Technical Trainer for PDA and ISPE, and author/presenter of over 150 technical works, passing on this knowledge is what drives me every day at NNE. I like to think that this value is important to our customers."

Jeff Odum is well known for his expertise within:

 

 

  • Mammalian cell culture
  • Monoclonal antibodies
  • BLA development and presentation to FDA
  • Multi-product facilities
  • Human vaccines
  • Clinical manufacturing facilities
  • Pilot plants
  • Large-scale production
  • Contract manufacturing
  • Training and professional development
  • Design, preconstruction, construction, start-up and validation support
  • Compliance
  • Quality systems
  • Strategic planning
  • Facility audits

Biography

Jeff Odum’s experience in the biopharmaceutical industry includes development and delivery of many of the industry’s major manufacturing projects, as well as consulting roles in compliance, strategic planning, and quality improvement/OEX.

Risk assessment, compliance auditing, and regulatory review are also focus areas of his consulting background. Jeff Odum has assisted companies in developing regulatory submissions and provided consultant review of licensing packages for new and renovated manufacturing facilities.

Jeff Odum has been awarded the CPIP certification as a Pharmaceutical Industry Professional. He is also a frequent lecturer and instructor to global companies and is the author of more than 70 published works on critical industry issues, including process improvement and execution to meet regulatory guidelines issued by the FDA and other international regulatory bodies.

Contact
T: +1 9196734745

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