Associate Principal Scientist, Nonclinical Drug Safety

Merck & Co. - West Point, PA

Full-time - Senior

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Associate Principal Scientist in Nonclinical Drug Safety at Merck Sharp & Dohme is responsible for supporting mutagenic and non-mutagenic risk assessment activities, as well as performing in silico assessments to characterize the mutagenic potential of impurities, metabolites, and molecules in drug discovery. This role requires collaboration with various scientific teams and involves conducting literature reviews and participating in external working groups.

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 strategies for impurity assessment.
• Conduct literature/database reviews of toxicology data.
• Support internal impurity-related initiatives and participate in external working groups.

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 in silico mutagenicity models (e.g., Lhasa, MultiCASE, Leadscope products).
• Strong knowledge of chemistry and metabolism in the context of genotoxicity.
• Ability to critically review toxicology data identified through literature/database searches.
• Database management experience.

Benefits

• Health insurance
• 401k
• Flexible work arrangements
• Paid holidays
• Professional development opportunities