Neil Stevenson
Biography
I’m an experienced CMC leader with an extensive background in process chemistry, drug development and regulatory strategy. I have a proven track record in strategic management of CMC teams, delivering GMP campaigns and enabling clinical trials. I have worked for over 20 years in both big pharma and biotech and have established a network of trusted CDMO suppliers. I’ve completed manufacturing processes in plants in UK, Europe, Singapore, India & China.
I’ve designed IMPD templates and delivered multiple IMPD submissions. I have significant expertise in genotoxicity / mutagenicity assessments with several cross-pharma publications in the field. I’m passionate about people leadership and continuous development through mentoring and coaching.
| Qualifications | PhD, MChem |
|---|---|
| Areas of Expertise |
Manufacturing People development Science, engineering and technology |
| Services Offered |
Drug discovery Quality assurance and risk management Manufacturing and process development Training and career development Business development, leadership and strategy |
| Markets Served |
Pharmaceutical and medicinal Biotechnology |
| Geographic Regions Served |
UK Europe North America |
Contact Neil Stevenson
Additional information
- Process development & optimisation
- Managing DS / DP development and manufacture at CDMOs
- Mutagenicity & Nitrosamine assessments
- Analytical development
- Regulatory writing and review of CMC modules
Route selection