Project Lead – Analytical Sciences (Extractables & Leachables, R&D)
While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.
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:
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