Project Lead – Analytical Sciences (Extractables & Leachables, R&D)
4 days ago
Huddersfield
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 Science