Senior Scientist/Principal Scientist

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POST DATE 9/9/2016
END DATE 10/15/2016

Zoetis US Kalamazoo, MI

Zoetis US
Kalamazoo, MI
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Full Time
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Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.

Our name, Zoetis (z -EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning pertaining to life. It signals our company's dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend.

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.

Zoetis Veterinary Medicine Research and Development is looking for an enthusiastic colleague to join the Safety Sciences group in Kalamazoo, MI for a challenging and fast paced position in regulatory toxicology. The candidate will work across the VMRD organization to produce thoughtful, well-researched scientific assessments that support regulatory submissions to global authorities. Some of these tasks and documents include:

* Integration of toxicology, human food safety, target animal safety, user safety and environmental assessments into submission documents

* Response to regulatory queries (Global)

* Toxicological assessments for residual solvents, excipients, impurities in the manufacturing process

* Medical assessments supporting pharmacovigilance and product quality

* User safety support for project teams (writes the documents, assembles various scenario calculations and risk mitigation proposals, packaging choice, label language)

* Safety Expert Reports for registration renewals

* Manufacturing: May aid in assessment of out of specification batches, segregation assessments, cleaning limits

* Environmental Risk Assessments: potentially work with environmental risk assessments including project strategy, document preparation, contracting and monitoring studies, study report review.

* Occasional travel: 15% depending upon study involvement

Minimum skills:

* PhD (or equivalent) plus at least 5 years of experience in a related field such as toxicology, pharmacology, environmental science is critical.

* Demonstrated skills in technical writing (protocols, reports, journal articles).

* Some experience in writing regulatory toxicology and/or environmental safety dossiers, as well as experience in the design, implementation, and interpretation of studies evaluating in vivo toxicity or similar experience would be expected.

* The candidate should have excellent organizational and communication (verbal and written English) skills, and the ability to work and be effective in a demanding team environment of a global company.

Desirable skills, education, 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.

* Some familiarity with environmental assessments and with internationally accepted mathematical models used to predict concentrations of product active ingredients in the environment would be strongly considered.

* Experience in conducting studies in a regulated environment (GLP-compliance) is desirable.