Senior R&D (Analytical) Scientist - Strong Focus On E&L / Nitrosamines

Walker Cole International Ltd; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global pharmaceutical company is seeking a Senior R&D Scientist to develop and validate analytical methods for Extractables, Leachables, and Nitrosamine testing. The ideal candidate will have substantial experience in GMP-regulated laboratories and proficiency in LC-MS and GC-MS methods. This role involves leading analytical method development, performing troubleshooting, and preparing technical documentation to support product submissions.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical Chemistry

Extractables & Leachables

Nitrosamines

LC-MS

GC-MS

Method Development

Validation

GMP

Tools

LC-MS

GC-MS

Job description

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.

Responsibilities

• 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.

Requirements

• 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.

Key words: Analytical Chemistry | Extractables & Leachables | Nitrosamines | LC-MS | GC-MS | Method Development | Validation | GMP | Pharmaceuticals | R&D