Job Description

Associate Principal Scientist to support mutagenic and non-mutagenic risk assessment activities as well as perform in silico assessments to characterize mutagenic potential.

The Impurity Strategy and In Silico Mutagenicity group within the Nonclinical Drug Safety organization is seeking an office-based scientist with expertise in impurity risk assessment. A core responsibility will be contributing to in silico assessments of mutagenic potential for impurities, metabolites, and molecules in discovery.

Additional responsibilities will include:

support of risk assessments activities involving mutagenic impurities, non-mutagenic impurities, and N-nitrosamines (e.g., leveraging ICH guidelines, regional health authority guidance, and developing novel strategies for impurities not covered by current guidance).

The candidate will be expected to work collaboratively with scientists within Nonclinical Drug Safety, medicinal chemistry, drug metabolism, process chemistry, analytical chemistry, manufacturing, and regulatory affairs. Other responsibilities include conducting literature/database review of toxicology data, support of internal impurity-related initiatives, as well as participation in external working groups and consortia.

Position Qualifications:

Education Minimum Requirement:

• Ph.D. in Toxicology, or related discipline with at least 3 years of post-doctoral and/or pharmaceutical industry experience.

• B.S. or M.S with at least 5 years of experience will also be considered.

Required Experience and Skills

• 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.

Preferred Experience and Skills

• 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.

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Requisition ID:R306474