Principal Scientist for Life Sciences Manchester, Nick Morley has over 15 years of pharmaceutical laboratory experience predominantly specializing in extractables and leachables.
After completing a degree in Chemistry, Nick started his career in the QC lab of a small generics pharmaceutical company gaining experience in a wide range of analytical techniques.
Next, Nick joined a larger team specialising in extractables and leachables moving from bench analyst to leading long term extractables and leachables projects and authoring regulatory files for various biopharmaceutical and cell and gene therapy drugs.
In 2018 Nick join Hall Analytical (Acquired By Element Materials Technology in 2021) as a subject matter expert in the field of extractables and leachables for medical devices and reduced-risk products.
As a trusted authority within the Life Science industry, Nick provides clients with technical guidance for design studies, authors whitepapers, presents at conferences and collaborates with external scientific organisations to keep up to date with the latest trends.
Based in Manchester, Nick is passionate about helping our clients deliver innovative products that enable patients to live healthier and more comfortable lives.
- Development of a novel sample preparation technique for the analysis of leachables in biopharmaceuticals
- Authoring a number of regulatory sections for NDAs, BLAs and MAAs
- Development of a leachable risk management process
- Extractables and Leachables
- Analytical Chemistry
- Sample Preparation
- Failure Mode and Effect Analysis
- Technical writing
Affiliations, memberships, working groups and conferences
- BSI CH/437 member
- CEN CH/437 WG 5 member
- Former ELSIE working group member
- Delivered 20+ conference presentations
Connect with Nick on LinkedIn
Extractables & Leachables Studies
Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.
We deliver tailored E&L studies of pharmaceutical, biologic, medical device, reduced risk, combination products and more, in accordance with regulatory expectations.