Metabolism Scientist

Location
Newark, Delaware
Salary
Competitive Market Rate Based On Experience
Posted
Jun 23, 2021
Closes
Aug 22, 2021
Field of specialization
Agrochemical, Biochemical, Biological
Job Type
Full time
  • FMC Global Regulatory Sciences organization is seeking a highly-motivated individual to work in our Human Health Sciences Group at our Newark, Delaware, research facility. The Metabolism Scientist position requires broad knowledge of organic and analytical chemistry, radiochemistry, biochemistry and/or pharmacology with practical experience with pharmacokinetics, pharmacodynamics, and metabolism.
  • This is an office-based position that utilizes experimental knowledge and regulatory know-how to support and advise internal multidisciplinary teams from early research and development through commercialization and registration of materials in the FMC agrochemical portfolio.
  • This position supports internal scientists from aligned disciplines, such as toxicology, field residue, analytical chemistry, and risk assessment to make informed decisions about overall safety and risks and the ability to register active ingredients and agrochemical products.
  • This position reports to the Manager of Metabolism and Residue.
  • Job Responsibilities 
    • Design, execute and interpret in vitro and in vivo metabolism studies at Contract Research Organizations.
    • Determine metabolic pathways and identify metabolites of agricultural active ingredients in various plant and animal matrices.
    • Plan and oversee the research of contract laboratories for metabolism studies to meet regulatory requirements.
    • Ensure all contract laboratory operations and record-keeping are of high quality and compliant with the GLP standards.
    • Review and summarize metabolism data from studies, literature, and other sources to prepare documents for submission.
    • Prepare written reports and oral presentations for product registration teams and regulatory agencies.
    • Prepare responses to regulatory questions in support of registration, renewal, and label expansion for products.
    • Effectively manage numerous tasks/projects simultaneously to meet internal/external deadlines.
    • Advance FMC core values of Safety, Respect, Stewardship, and Ethics.
  • Qualifications
    • PhD in Chemistry, Biochemistry, Pharmacology, Medicinal Chemistry, Pharmaceutical Sciences or related discipline and a minimum 2+ years of relevant work experience in a commercial setting relevant to the pharmacokinetics and metabolism of organic chemicals. 
    • Or, MS in Chemistry, Biochemistry, Pharmacology, Medicinal Chemistry, or related discipline and a minimum 5+ years of relevant experience.
    • Broad scientific knowledge in organic chemistry, analytical chemistry, pharmacology, metabolism, pharmacokinetics or similar scientific discipline related to agricultural or pharmaceutical products.
    • Ability to design and manage appropriate ADME, plant and livestock animal metabolism studies under regulatory guidelines. Familiarity with the isolation and structural identification of metabolites and degradants from biological systems using radiochemical and spectroscopic techniques.
    • Project management skills to monitor, manage, and meet deadlines for GLP-compliant studies conducted through external contract facilities. 
    • Excellent and effective written and verbal communication skills.  Technical writing capability for comprehensive scientific reports and presenting results to/for appropriate target audiences. 
  • Additional Beneficial Experience:
    • Registration support for agrochemical, pharmaceutical, or specialty chemicals.
    • Experience in preparing metabolism dossiers, scientific justifications/rationales for study waivers and overviews for registration submissions.
    • Participation in scientific societies, associations, and task forces.