Kevin is a senior leader with over 30 years of extensive advanced aseptic manufacturing, engineering, operational and quality management experience in the design, delivery and start-up of parenteral and other GMP manufacturing facilities. Kevin has a strong background in CGxPs, safety, operational excellence, continuous improvement, commissioning & qualification, impact and risk assessments, change controls, regulatory compliance, regulatory inspections, good documentation practices, single-use systems, training, technical writing & communication, project management, and leading and developing cross-functional and process improvement teams. He thrives in either self-directed or team environments. He is a results-oriented, energetic and curious individual with a strong technical aptitude, and a desire to continuously improve.
Education
- B.A. - Biology, University of North Carolina at Greensboro
Professional Associations
- International Society for Pharmaceutical Engineering (ISPE)
Industry Experience
- Novartis Gene Therapies
- Eli Lilly and Company
- Medtronic
Publications
- Debbs, Kevin. “Sterile Product Manufacturing Facilities.” ISPE Baseline Guide, Volume 3, Third Edition.
- Debbs, Kevin. “Planning and Executing Cycle Development for the Vapor Hydrogen Peroxide Decontamination of a Filling Line Isolator.” BioProcess Online, May 2017
- Debbs, Kevin. “Five Tips to CMO Selection,” Institute of Packaging Professionals (IOPP) Spotlight on Contract Packaging, 04 January 2016.
Presentations
- Debbs, Kevin. “Outsourcing: Choosing a Contract Manufacturing Organization.” Pack Expo, Sep 2017.
- Debbs, Kevin. “Isolator Glove Management.” ISPE Barrier Isolator Conference, 2004.