Job Description
Project Lead – Analytical Sciences (Extractables & Leachables, R&D)
Walker Cole International is partnered with a global pharmaceutical organisation to appoint a Project Lead – Analytical Sciences (Extractables & Leachables, R&D). This position is ideal for an experienced Analytical Scientist looking to step into project leadership, driving innovation and compliance in pharmaceutical R&D.
Key Responsibilities
1. Lead analytical projects focused on Extractables & Leachables (E&L) and Nitrosamines, ensuring delivery of high-quality data for regulatory submissions.
2. Develop, validate, and transfer analytical methods to support Research & Development (R&D) and Quality Control functions.
3. Prepare documentation for CTD Module 3 and provide responses to Health Authority requests.
4. Represent Analytical Development in cross-functional pharmaceutical projects, working closely with QA, RA, and Manufacturing.
5. Mentor and guide Analytical Scientists, supporting technical development and training.
6. Perform risk assessments for Extractables & Leachables and contribute to problem-solving in analytical chemistry.
7. Ensure all activities are conducted in compliance with GLP, GMP, and pharmaceutical quality systems.
8. Support early pharmaceuti...