Toxicologist at Zoetis

Kalamazoo, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Veterinary Medicine, PharmaceuticalsIndustries

Requirements

Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline (Master’s degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered)
Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles)
Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience
Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments
Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment
Excellent verbal and written communication skills in English
Proficiency in MS Office, and toxicology databases for literature research and data analysis
(Preferred) Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations

Responsibilities

Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products
Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits
Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures
Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development
Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE)
Support pharmacovigilance, product quality, and qualification of out-of-specification batches
Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products
Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration
Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights
Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology
Travel up to 10% for collaborations, regulatory engagements, or conferences as needed

Skills

Key technologies and capabilities for this role

ToxicologySafety AssessmentOELsOEBsTTCPDEADIMoEREACHPharmacovigilanceRisk AssessmentLiterature ReviewExtractables and Leachables

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

Where is this position located?

The role is based in Kalamazoo, MI.

What are the key responsibilities for this Toxicologist role?

Key responsibilities include conducting toxicological assessments for drug products and manufacturing, developing Occupational Exposure Limits, providing user and worker safety support, establishing safe exposure levels, and performing toxicology data analysis and literature reviews.

Does this role involve collaboration with other teams?

Yes, the role requires cross-collaboration with VMRD, Global Manufacturing and Supply (GMS), R&D, Manufacturing, Product Quality, and Sustainability teams.

What travel is required for this position?

The role involves up to 10% travel for collaborations, regulatory engagements, or conferences.