Summary

Location: Basel, Switzerland

Role Purpose:
We are seeking a highly motivated Analytical Expert to join Analytical Research & Development (ARD). ARD sits within the Technical R&D Department of Development and plays an essential role in the characterization and analysis of Drug Substances and Drug Products (classical small molecules and radioligand therapies) from the time they leave the discovery lab until they are transferred to commercial production.

The responsibilities of the Analytical Expert comprise the development, validation and application of analytical methods for trace analytics of e.g. genotoxic impurities like nitrosamines in drug substances and drug products or trace level contaminants in excipients. The selected candidate is also expected to support the implementation of the analytical global strategy for trace level analytics and contribute to its development.

• Development and validation of analytical methods for trace analytics of e.g. genotoxic impurities like nitrosamines, or other trace level contaminants, using hyphenated separation and detection techniques, like e.g. mass spectrometry and other state-of-the-art technologies.
• Support implementation of global analytical strategy for trace analytics and contribute to its ongoing evolution.
• Plan, report, correlate and interpret results of scientific experiments and investigations according to the agreed timelines. Ensure compliance to cGMP.
• Write and review analytical documents (raw data review / approval, development reports, validation protocols and reports, etc.).
• Provide scientific guidance to laboratory scientists. Develop, coach and mentor laboratory scientists and other associates.
• Work closely with the analytical project teams to implement appropriate testing protocols and address any issues that arise during the testing.
• Propose and discuss state-of-the art science and technology, staying updated with the latest developments in regulatory guidelines related to trace level analytics e.g. nitrosamines.
• Exhibit strong team spirit and promote knowledge exchange.

• Knowledge of regulatory guidelines related to nitrosamines, genotoxic impurities and trace level analytics (e.g., EMA, FDA).
• Proficiency in using hyphenated analytical separation and detection techniques including mass spectrometry.
• Proven experience in analytical method development and validation, particularly for trace level analytics, e.g. nitrosamines.
• Strong problem-solving skills and attention to detail.
• Excellent communication and collaboration skills.
• Ability to work independently and as part of a team.

• PhD or Master degree in Analytical Chemistry / Chemistry or equivalent.
• Minimum of 3 years' experience in the pharmaceutical industry.
• Good knowledge of English (oral and written).