Merck Principal Scientist in Helena, Montana
Principal Scientist to evaluate the safety of mutagenic and non-mutagenic impurities as well as perform in silico assessments to characterize mutagenic potential of metabolites and molecules in early discovery.
The Impurity Strategy and In Silico Genetic Toxicology group within the ADME/Discovery Toxicology organization is seeking an office-based Principal Scientist with expertise in impurity risk assessment (e.g., addressing recommendations in ICH Q3A, Q3B, Q3C, Q3D, and/or ICH M7) and conducting in silico assessments to investigate mutagenic/genotoxic potential. The candidate will also contribute to development of derisking strategies for potentially genotoxic metabolites and molecules in early discovery. The candidate will be expected to work collaboratively with scientists from Nonclinical Drug Safety, medicinal chemistry, ADME, process chemistry, analytical chemistry, and regulatory affairs-CMC. Other responsibilities include development of genetic toxicology testing strategies related to impurity risk assessment as well as participation in external working groups and consortia.
Minimum required education:
Ph.D. in Toxicology or Chemistry, or related discipline, with post-doctoral and/or pharmaceutical industry experience.
Required Experience and Skills:
Strong knowledge of chemistry and metabolism in the context of genotoxicity.
Understanding of non-clinical toxicology testing including genetic toxicology testing.
Working knowledge of ICH and regional health authority guidance. Practical experience with commonly used in silico models (e.g., Lhasa, MultiCASE, and/or Leadscope products).
Excellent communication (oral and written) and collaboration skills.
Preferred Experience and Skills
Ability to determine the sufficiency of toxicology data (e.g., genetic toxicology, repeat-dose toxicology, DART, and carcinogenicity data) identified through database searches.
Assigning ICH M7 classifications. Deriving exposure limits for mutagenic and non-mutagenic impurities.
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Flexible Work Arrangements:
Hybrid, On-Site, Remote Work, Telecommuting
Valid Driving License:
Number of Openings:
Requisition ID: R201850