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

Walker Cole International Ltd; United Kingdom; On-site; GBP 50,000 - 75,000; Full time

Job summary

A global pharmaceutical company in the UK is seeking a Senior R&D Scientist to develop and validate analytical methods for Extractables, Leachables, and Nitrosamine testing. The successful candidate will collaborate with various teams and ensure compliance with GMP standards.

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

Extractables & Leachables

Nitrosamine analysis

LC-MS

GC-MS

Problem-solving

Communication

Documentation

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.

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.

Analytical Chemistry Extractables & Leachables Nitrosamines LC‑MS GC‑MS Method Development Validation GMP Pharmaceuticals R&D