Toxicologist

Zoetis; United States; On-site; USD 91,000 - 148,000; Full time

Benefits offered by this job

Healthcare

Dental coverage

Retirement savings benefits

Paid holidays

Vacation

Disability insurance

Job summary

A leading veterinary pharmaceutical company is seeking a skilled Toxicologist to join their team in Kalamazoo, MI. This role involves conducting safety assessments for drug products, developing occupational exposure limits, and supporting regulatory compliance. The ideal candidate has a Ph.D. in toxicology and strong technical writing skills. Competitive salary range of $91,000 - $148,000, alongside a comprehensive benefits package including healthcare and retirement savings.

Qualifications

• Ph.D. with 2-3 years of experience or Master's with 8 years in toxicology.
• Experience in regulatory-quality technical document preparation.
• Excellent verbal and written English communication skills.

Responsibilities

• Conduct safety assessments for drug products and manufacturing.
• Develop Occupational Exposure Limits and user safety support.
• Perform toxicology gap analysis and literature review.

Skills

Toxicological assessment

Technical writing skills

Problem-solving skills

Study design and implementation

Collaboration in a global matrix environment

Health hazard assessments

Education

Ph.D. in toxicology or related discipline

Master's degree in toxicology with substantial experience

Tools

MS Office

Toxicology databases

Job description

Join to apply for the Toxicologist role at Zoetis

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

Base Pay Range: $91,000 - $131,000

Base Pay Range: $103,000 - $148,000

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.

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