Regulatory Toxicology Scientist
Zoetis

Kalamazoo, Michigan

Posted in Pharmaceuticals


This job has expired.

Job Info


Zoetis Veterinary Medicine Research and Development (VMRD) is looking for a skilled Toxicologist to join the Safety Sciences group based in Kalamazoo, MI for a challenging and dynamic position that provides technical leadership and expertise in regulatory toxicology. The candidate will work across the VMRD organization to produce sound, well-researched scientific assessments that justify product safety across therapeutic areas and across species, and to support regulatory filings to global authorities.

The responsibilities include:

  • Regulatory filing support: Integration of toxicology, human food safety, target animal safety and user safety assessments into filing documents
  • Toxicological Assessment support: Safety assessments for residual solvents and excipients
  • Toxicological Assessment supporting manufacturing: Qualification of impurities in the manufacturing process; safety assessments for extractables and leachable, cross-over contamination of products at shared facilities and cleaning limits, and out of specification batches
  • User safety support: Safety support for project teams (writes the documents, assembles various scenario calculations and risk mitigation proposals, packaging choice, label language)
  • Perform toxicology gap analysis, data mining, QSAR analysis, read across and hazard exposure calculations
  • Medical assessments supporting Pharmacovigilance and product quality
  • Response to global regulatory queries

This position will be hired remotely; however, the candidate should be aware that eventual relocation to Kalamazoo may be considered for the position.

  • Minimum skills
  • PhD (or equivalent) plus at least 5 years of experience in toxicology and/ or related scientific discipline is critical. Master's degree in toxicology with 10 years of experience shall be considered.
  • Demonstrated experience in preparing regulatory quality toxicology dossiers, and skills in technical writing (protocols, reports, journal articles)
  • Experience in the study design, implementation, and interpretation of studies evaluating in vitro and in vivo toxicity or similar experience
  • Excellent organizational and communication (verbal and written English) skills
  • Ability to work and be effective in a demanding matrix environment of a global company with multiple competing priorities
  • Advanced skills in MS office applications and experience in toxicology databases and literature searches
  • Highly organized with superior attention to detail. Able to solve complex problems requiring thorough scientific assessment.
  • Desirable skills, experience, attributes:
  • Board certification in toxicology
  • Knowledge of global regulatory requirements for the preparation of toxicology to support human food safety filings, and user safety assessments.
  • Knowledge of medicinal chemistry and human and animal xenobiotic metabolism

Full time

Regular

Colleague

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 zoetiscolleagueservices@zoetis.com 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.


This job has expired.

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