Human Foods Program SME II - Guidehouse : Job Details

Job Posting

What You Will Do

• Provide scientific and technical guidance on analytical chemistry analysis for the Office of Chemistry and Toxicology (OCT).
• Help evaluate the validation and implementation of analytical chemistry methods for use in regulatory labs
• Support the development of single laboratory and multi-laboratory validation plans for methods.
• Assist with cross-agency (FDA, HFP, and OCT) method development, validation, and implementation coordination groups on validation guidelines and implementation plans.
• Work closely with department leadership and stakeholders to develop research and method development plans for projects in areas related to chemical contaminants and direct/indirect food additives, and packaging.
• Act as liaison between OCT and Laboratory Accreditation for Analyses of Foods (LAAF) Program and support the expansion of the LAAF program.

What You Will Need:

• Master's degree in chemistry, biology, pharmaceutical sciences or related discipline in public health or health science
• Broad knowledge in preclinical & clinical product development.
• Minimum of 10 years of experience and solid hands-on experience in pharmacokinetics (small & large molecules), Pharmacokinetic/Pharmacodynamic modeling & Simulations, bioanalysis, drug metabolism, translational medicine, and drug delivery and formulation.
• Scientific discipline experts will conduct chemical, biological, toxicological or epidemiological risk and safety assessments to evaluate health outcomes or impacts on such as: dietary intake of substances added to or found in food; application of new approach methods (NAMs) including the Threshold of Toxicologic Concern to substances added to or found in food, and quantitative human health risk or safety analysis of substances added to or found in food.
• Demonstrated track record in analyzing and interpreting complex scientific data.
• Exceptional oral and written communication skills and ability to network and build consensus within a multi-disciplinary organization.

What Would Be Nice To Have

• Drug regulatory experience is desired, particularly in regulatory science research.
• Ph.D. degree in biology, pharmaceutical sciences, or related discipline