Walker Cole International is searching for a Senior R&D Scientist - E&L and Nitrosamine Method Development - to join a global pharmaceutical company at their R&D and GMP-regulated site in the UK.
As the Senior Scientist, you will play a key role in developing and validating analytical methods to support Extractables, Leachables, and Nitrosamine testing across pharmaceutical products and materials.
Your responsibilities will include:
*
Leading and supporting risk assessments and analytical method development for E&L and Nitrosamines.
*
Developing, validating, and transferring LC-MS and GC-MS methods in compliance with GMP and regulatory guidelines.
*
Performing data interpretation, troubleshooting, and technical investigations to resolve analytical issues.
*
Preparing technical reports and regulatory documentation to support product filings and submissions.
*
Collaborating with QC, QA, and Regulatory Affairs teams to ensure analytical compliance and product quality.
*
Contributing to continuous improvement within analytical R&D and supporting method optimisation projects.
To be successful, you will have:
*
Proven experience in Extractables & Leachables and/or Nitrosamine analysis within a GMP-regulated laboratory.
*
Hands-on experience with LC-MS or GC-MS and method validation techniques.
*
Strong problem-solving, communication, and documentation skills.
Analytical Chemistry | Extractables & Leachables | Nitrosamines | LC-MS | GC-MS | Method Development | Validation | GMP | Pharmaceuticals | R&D