The candidate will design and conduct work to understand the absorption, distribution, metabolism, and elimination of pharmaceuticals in food producing animals to demonstrate the safety of veterinary products. The candidate will collaborate extensively with bioanalytical, target animal safety, toxicology, pharmacokinetics, environmental, clinical, and regulatory scientists as part of multidisciplinary project development teams.
The incumbent will conduct research on the pharmacokinetics, drug metabolism, and food animal drug residues of new animal drugs and/or existing Elanco Animal Health products. This scientist develops human food safety strategies for drug development and provides technical support for global regulatory dossiers.
Basic Minimum Requirements:
- PhD degree or MS with 10+ years relevant experience in Biochemistry, Toxicology, Environmental Science, Pharmacology or related field with equivalent experience.
- Design, conduct and summarize pharmacokinetic and drug metabolism studies used to evaluate candidate molecule characteristics and global product registrations.
- Design, conduct and summarize food animal residue studies to support global livestock product registrations.
- Design, conduct and summarize metabolite profiling analysis of samples from radiolabel ADME studies.
- Develop and validate analytical methods to quantify residues of small-molecule drugs in blood/plasma, tissues, excreta, and other biological matrices at the low mg/kg to sub-ng/kg level.
- Recruiting contract research organizations and provide oversight of studies for pharmacokinetic, residue and drug metabolism studies.
- Prepare international regulatory documents and position papers for residue and pharmacokinetic issues.
- Ensure that submission packages meet relevant international regulatory requirements while addressing key scientific questions.
- Develops and follows appropriate standards to ensure compliance with applicable regulatory requirements (GLP and GCP) and corporate quality standards.
- Familiar with global regulatory requirements (VICH/ICH, FDA/CVM, OECD, or country/regional requirements) for human or veterinary pharmaceuticals.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status