Principal Scientist / Senior Principal Scientist

In this role, you drive in silico mutagenicity assessments to support safe development of innovative medicines. You work with global development teams to derisk mutagenic impurities, influence regulatory decisions, and provide expert judgments on safety findings. You will communicate results to cross-functional teams and health authorities, shaping risk-based decisions. The Senior Principal Scientist path adds leadership in the global genotoxicity strategy and engagement with scientific committees, driving standards and best practices.

• comprehensive benefits and wellbeing package

• Coordinate, evaluate, and conduct in silico mutagenicity assessments per ICH M7 and review related literature
• Develop and support derisking strategies for mutagenic impurities/metabolites across development stages
• Prepare scientific reports with expert judgment and contribute to regulatory submissions
• Advise R&D teams on mutagenic impurities/metabolites and exposure limits for mutagenic carcinogens
• Represent results in international project teams and support risk-based decision making
• Respond to health authority inquiries on ICH M7 topics and coordinate global project requirements
• Senior Principal Scientist: lead global genotoxicity strategy, handle complex regulatory issues, contribute to scientific committees
• Senior Principal Scientist: drive scientific standards and best practices
• Collaborate with internal and external stakeholders to ensure regulatory compliance

• PhD in Chemistry, Biology, Biochemistry or comparable degree with relevant experience; or Master’s in Biology or Computer Science
• Solid knowledge of mutagenicity, structural reactivity, and genetic toxicology
• Experience in in silico mutagenicity prediction, relevant software tools, derisking strategies, and genetic toxicology assays
• Experience in literature research and use of scientific databases
• Knowledge of pharmaceutical development and genetic toxicology in drug development
• Ability to coordinate multiple stakeholders and communicate complex findings in German and English
• Senior role requires extensive experience in applying in silico mutagenicity assessments and leading cross-functional stakeholders
• Experience representing scientific positions in health authority interactions

• cross-functional collaboration
• stakeholder coordination
• clear scientific communication
• in silico mutagenicity prediction
• ICH M7 adherence
• derisking strategies for mutagenic impurities/metabolites