Analytical Science & Technology Expert

As our Analytical Science & Technology Expert, you’ll be the go to partner for Quality Control when analytical methods and technologies need to be validated, transferred or improved for day to day use. You’ll plan and execute analytical application and method life cycle activities, including method validation, verification and transfer work, write and review protocols and reports, periodic reviews and work side by side with the lab to troubleshoot atypical results and strengthen method performance over time. Your work keeps methods and documentation inspection ready, supports updates from pharmacopoeias and guidelines, and helps ensure consistent product quality in a Good Manufacturing Practice environment.

Summary

Internal title: AS&T Expert

About the Role

Key Responsibilities

• Lead analytical method validation, verification and transfer activities supporting routine Quality Control laboratory testing.
• Write, review and execute protocols and reports following International Council for Harmonisation guidelines, pharmacopoeias and standard operating procedures.
• Serve as the analytical expert for assigned Quality Control methods and technical transfer activities.
• Maintain and improve analytical methods for release, stability and in-process testing performance.
• Contribute analytical expertise to regulatory submissions, variations and health authority responses.
• Act as a Quality control analytical expert during audits and inspections, ensuring clear explanations and inspection-ready documentation.
• Implement updates driven by pharmacopoeias and regulatory expectations within Quality Control laboratories.
• Perform regular reviews of analytical methods and computerized laboratory systems using testing data and product knowledge.
• Support planning, execution and tracking of the analytical Validation Master Plan.
• Drive introduction of new technologies and improvement projects within Analytical Science and Quality Control laboratories.

Essential Requirements

• Several years of experience in Quality Control, Analytical Science and Technology, or analytical development within pharmaceuticals or biotechnology.
• Hands-on experience with routine Quality Control testing in a Good Manufacturing Practice environment.
• Strong practical knowledge of core laboratory techniques such as elemental analysis and radiation measurement, depending on product needs.
• Experience with analytical method validation, verification and transfer, following international guidelines and pharmacopoeias.
• Ability to analyze and interpret analytical data using chromatography systems and laboratory data trending tools.
• Good understanding of Good Manufacturing Practice, data integrity principles and Quality Control laboratory workflows.

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?