Job Title

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 Lead analytical projects focused on Extractables & Leachables (E&L) and Nitrosamines, ensuring delivery of high-quality data for regulatory submissions. Develop, validate, and transfer analytical methods to support Research & Development (R&D) and Quality Control functions. Prepare documentation for CTD Module 3 and provide responses to Health Authority requests. Represent Analytical Development in cross-functional pharmaceutical projects, working closely with QA, RA, and Manufacturing. Mentor and guide Analytical Scientists, supporting technical development and training. Perform risk assessments for Extractables & Leachables and contribute to problem-solving in analytical chemistry. Ensure all activities are conducted in compliance with GLP, GMP, and pharmaceutical quality systems. Support early pharmaceutical product development, including prototype stability testing, raw material evaluation, and feasibility studies. About You The successful candidate will have: A strong background in analytical chemistry with proven expertise in Extractables & Leachables and/or Nitrosamines. Demonstrated experience in method development, validation, and transfer within pharmaceuticals. A track record of leading analytical projects in a regulated environment. Knowledge of regulatory requirements and experience with regulatory submissions. Excellent communication, mentoring, and stakeholder management skills. Keywords: Analytical Scientist Jobs | Extractables and Leachables | E&L Analytical Scientist | Nitrosamines Analytical Chemistry | Analytical Project Lead Pharmaceuticals | Pharmaceutical R&D Jobs | Analytical Method Development | Analytical Method Validation | Method Transfer Pharmaceuticals | CTD Module 3 | Regulatory Submissions Pharma | GLP GMP Analytical Chemistry | Pharmaceutical Analytical Development | Senior Analytical Scientist Roles | Analytical Science Project Lead | Pharma Analytical Team Leader | Biopharma Analytical Jobs Europe | Pharmaceutical Quality and Regulatory Science55b20050-bc17-4e5d-bfce-3c406318dffc