Senior Drug Substance Consultant
Chris has 40 years of diverse management and business experience in API, fine chemical manufacturing, and contract custom synthesis. Principle responsibilities have included operations and project management, product introduction, product costing, regulatory compliance, and the achievement of financial and strategic targets.
Product introduction ran the gamut from process development chemistry through large scale manufacturing. His hands-on and analytical approach has led to the successful commercialization of several API’s, chemical process optimization, and improved site operations, including plant utilization.
- CMC NDA submission including authoring, QA checking and editing of drug substance and drug product module 3 CMC sections,
- Directed the cGMP manufacture of bulk API’s and developed SOPs, batch records, policies and technology transfer documentation,
- Directed the activities of a 17 reactor cGMP pilot plant (30 to 750 gallon scale), four kilo labs.
Prior to joining DSI, Dr. Brookes served has as Technical and Operations Director for three bulk API manufacturing facilities. He holds a Ph.D. in Chemistry from the University of Birmingham.
- API Manufacturing
- Process Optimization
- Plant & Site Utilization
- Authoring Submissions
- Tech Transfer
- Generic Products
- Pilot Plant Operations