Richard Francis

I am an accomplished professional 40 years + with specialist experience in CMC activities covering development, manufacturing, analytical testing / characterisation, and regulatory agency interactions. This applies to many product types such a monoclonal antibody (all variant types), nanobodies, Vaccines, Cell and gene therapy products, recombinant proteins and biosimilars. I am well versed in all relevant regulations and have conducted many training sessions in multiple companies covering ICH and related regulations. Have guided and been part of many product submissions and regulatory agency interactions including face to face meetings and on-site Pre Approval Inspections. I am a collaborative problem solver with strong leadership qualities. Experience in facilitating multi-disciplinary and virtual teams across multiple geographical regions.

Key expertise offerings:

• Technical problem solving:
  I have assisted in successful resolution of many technical problems in different stages of product development / manufacturing. I enjoy sharing knowledge and seeking a winning resolution of issues for client companies.
• Regulatory CMC activities:
  Directly involved in preparation of regulatory CMC submissions (drafting and technical review) from IND through to BLA/MAA module 3 eCTD submissions. Experienced in direct regulatory agency interaction such as face 2 face meetings, managing and direct involvement in product Pre Approval Inspections and managing regulatory agency requests. This includes MHRA, FDA, EMA and PMDA as well as other regional agencies.
• Training:
  Experienced trainer (20+ years) covering in house training sessions for multiple disciplined groups of up to 25 delegates over single or multiple days. Covering topics such as ICH guidance’s, enhanced process development, development of control strategies and successful performance of right first-time process validation to highlight a few. This proves to be a good cost-effective way of training groups and ensuring delivery of a common understanding on specific topics.
• Interim management:
  I have successfully performed in multiple interim management roles such a project lead through to Chief Operations Officer. I can facilitate business continuity and progression while companies are developing or looking for specific expertise for a permanent position.