Analytical Chemist

Job Summary:

We are seeking a highly skilled Analytical Chemist to lead the execution of technical projects, method validations, and analytical method transfers between laboratories.

Key Responsibilities:

• Support and help to develop analytical validation strategies, ensuring all aspects of analytical development and validation are delivered to the required standard of science, quality, and regulatory compliance in accordance with agreed timelines.
• Assist with and ensure Quality Management System processes such as Change Controls, Deviations, CAPAs, and Quality Risk management procedures are undertaken and progressed as required.
• Plan, coordinate, and conduct laboratory work to support analytical projects, this can include analysis of raw materials, intermediates, and finished products.
• Record, evaluate, and present data generated during laboratory work both internally and by third parties, by applying expert scientific knowledge, demonstrating a practical approach, and providing appropriate and innovative solutions.
• Be proficient and proactive in the use of regulatory and other relevant guidelines, including pharmacopoeias, to ensure appropriate compliance within projects.
• Provide appropriate and consolidated CMC or pharmaceutical analysis opinion to ensure successful project outcomes.

Requirements:

• Minimum 5 years of experience in pharmaceutical testing laboratories.
• Proven track record in analytical chemistry and/or analytical development for drug product formulations.
• Experience in CMC/regulatory guidelines and filings.
• Significant industrial experience working in or maintaining a GMP/GLP compliant analytical environment.
• Experience with EU regulatory guidelines, quality management systems, and quality risk assessments.

About Mundipharma:

Mundipharma is a company that prioritizes diversity and inclusion, focusing on making a positive difference for our customers and their patients. We offer a collaborative, inclusive work environment and flexible benefits package opportunities for learning and development.