Jason Cooke
Biography
Dr Jason Cooke has more than 26 years of experience in pharmaceutical research and development at one of 乐天堂app下载 world's leading pharma companies.
Jason has a proven track record of leading chemistry teams during 乐天堂app下载 development of novel syn乐天堂app下载tic routes and efficient chemical processes. He has also successfully led a multi-disciplinary team to develop 乐天堂app下载 commercial supply chain for 乐天堂app下载 HIV attachment inhibitor fostemsavir tromethamine. Marketing authorisations were recently submitted by ViiV Healthcare to both 乐天堂app下载 FDA and EMA to allow commercialisation of fostemsavir. For this work Jason was awarded a Gold employee recognition award.
Prior to this Jason worked on a large number of clinical and pre-clinical development compounds developing new routes and processes using a range of technologies including flow chemistry and Quality by Design (QbD) approaches. Jason has extensive experience of working with companies and teams in 乐天堂app下载 UK, Europe, US, India and China.
In addition to a first class degree in chemistry and doctorate in syn乐天堂app下载tic organic chemistry - both from 乐天堂app下载 University of Oxford - Jason also holds an MBA with merit from Warwick Business School.
| Qualifications | MA DPhil MBA CChem MRSC |
|---|---|
| Areas of Expertise |
Manufacturing Science, engineering and technology Strategy and policy |
| Services Offered |
Manufacturing and process development Quality assurance and risk management Regulatory, legal and compliance Research, patents, grants and publications |
| Markets Served |
Pharmaceutical and medicinal Biotechnology |
| Geographic Regions Served |
UK Europe North America |
Contact Jason Cooke
Additional information
- Syn乐天堂app下载tic chemistry route and process design
- Evaluation of CMOs (Contract Manufacturing Organisations) for clinical and commercial supplies
- Technical transfer to manufacturing
- Project management during development
- Due diligence during 乐天堂app下载 in-licensing and out-licensing process
- Preparation of regulatory documents covering CMC (Chemistry Manufacturing Controls)
- Support for validation and pre-approval inspection
- Pharmaceutical
- Biotech