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 disciplineis critical. Master's degree in toxicology or closely related disciplinewith 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... For full info follow application link.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [email protected] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
