Associate Principal Scientist, Nonclinical Drug Safety

Merck KGaA Darmstadt Germany - West Point, PA

Full-time - Senior

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Associate Principal Scientist will support mutagenic and non-mutagenic risk assessment activities, focusing on in silico assessments to characterize mutagenic potential. This role is part of the Impurity Strategy and In Silico Mutagenicity group within the Nonclinical Drug Safety organization, requiring expertise in impurity risk assessment and collaboration with various scientific teams.

Responsibilities

• Contribute to in silico assessments of mutagenic potential for impurities, metabolites, and molecules in discovery.
• Support risk assessment activities involving mutagenic impurities, non-mutagenic impurities, and N-nitrosamines.
• Leverage ICH guidelines and regional health authority guidance to develop novel strategies for impurities not covered by current guidance.
• Conduct literature/database reviews of toxicology data.
• Support internal impurity-related initiatives and participate in external working groups and consortia.

Requirements

• Ph.D. in Toxicology or related discipline with at least 3 years of post-doctoral and/or pharmaceutical industry experience, or B.S. or M.S. with at least 5 years of experience.
• Experience with mutagenic and non-mutagenic impurity risk assessment.
• Understanding of nonclinical toxicology testing including genetic toxicology testing.
• Working knowledge of ICH and regional health authority guidance.
• Excellent communication (oral and written) and collaboration skills.

Nice-to-haves

• Experience with N-nitrosamine risk assessment.
• Practical experience with commonly used in silico mutagenicity models (e.g., Lhasa, MultiCASE, and/or Leadscope products).
• Strong knowledge of chemistry and metabolism in the context of genotoxicity.
• Ability to critically review toxicology data (e.g., genetic toxicology, repeat-dose toxicology, carcinogenicity data) identified through literature/database searches.
• Database management.

Benefits

• Hybrid work model with three days on-site per week and one remote working day.
• VISA sponsorship available.