Senior R&D (Analytical) Scientist - Strong focus on E&L / Nitrosamines

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