Job Description
Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes.
Responsibilities: - Toxicological Assessment for Drug Products : Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products
- Toxicological Assessment for Manufacturing : 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.
- Occupational Safety : Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures.
- User and Worker Safety : 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.
- Safe Exposure Level 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).
- Health Hazard/ Medical Assessments : Support pharmacovigilance, product quality, and qualification of out-of-specification batches.
- Regulatory Support : Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products.
- Toxicology Data Analysis & Literature Review : Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration.
- Hazard Communication and Chemical Regulatory Compliance (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.
- Cross-Collaboration and Technical Leadership: 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.
- Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology.
Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed.
Minimum Qualifications - Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. 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
Desirable Skills, Experience, and Attributes: - Board certification in toxicology (e.g., DABT, ERT) and/or DVM.
- Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations.
- Experience in preparing safety data sheets.
Full time
Regular
Colleague
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Job Tags
Full time, Local area,