Richard FrancisOwner and Senior Director at Francis Biopharma
Richard has over 30 years’ experience in the biopharmaceutical industry at companies such as Celltech, Centocor, GSK, Protherics and BTG. Richard’s expertise includes product technology transfer utilizing program management methods and is well versed in regulatory agency requirements. Richard also has experience in the implementation of QbD approaches for biopharmaceutical products, process and analytical development requirements and has held senior management roles for process development, technical support, manufacturing operations and product lifecycle programs.
Richard has had significant involvement in the regulatory agency submissions both preparation of content and interaction with regulatory agency staff, covering many FDA, EMEA, Japanese and rest of the world approved biological products. In addition, Richard has had direct involvement in manufacturing site agency inspections and compliance audits.
Richard has worked with a diverse set of product types including monoclonal antibodies, polyclonal antibodies, recombinant DNA proteins, plasmid DNA and viral gene therapy products at all stages of their life cycle development.