Dennis H. Roberts
Senior Project Management Consultant
Mr. Roberts is a Pharmaceutical Development leader with proven proficiency gained through 30+ years’ experience guiding teams to successfully bring products to USP/EP/JP markets and maintain them. He has extensive experience with international GMP regulations for development, testing, manufacturing and commercialization, API, sterile injectable (liquid and lyophilized) and solid oral product development, testing and manufacturing. Coordinates with internal/external teams and vendors as well as negotiates with global regulatory bodies. He serves as a key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction and operational excellence.
- Analytical Laboratory Management
- Drug Product Development
- Regulatory and Industry Compliance
Before joining DSI, Mr. Roberts served as Executive Director, Product Development at Xeris Pharmaceuticals. He holds a degree in Chemistry from Washington State University.
- CMC Development Teams
- Regulatory Compliance
- Global Health Authority Inspections
- Investigations and OOS Resolution
- Laboratory Management
- Project Management
- Drug Development
- PAI Inspection Lead