About the role
Job Family: Scientist Travel Required: Up to 10% Clearance Required: Ability to Obtain Public Trust This position will aid our federal client's public health risk and/or safety assessments of infant formula submissions by providing consultation to staff on new
requirements under the Infant Formula Final Rule and collaborating with regulatory staff to provide guidance to industry with regards to the accurate performance of the PER under the new regulations. What You Will Do: Provide consultive services to staff on the new Protein Efficiency Ratio (PER)
requirements and other chemistry-specific areas of an infant formula notification. In close coordination with the Infant Formula Premarket Review Staff: ○ Evaluate analytical methods and protein quality issues; ○ Evaluations of infant formula notification requests for additional data and information regarding protein efficiency assays and bioassays for determination of protein quality in complex infant formula matrices; ○ Develop draft guidance for conduct and evaluation of protein efficiency ratio and growth monitoring studies in infant formula submissions; ○ Respond to and\or meet with industry with regards to the accurate performance of the Protein Efficiency Ratio (PER)
requirements under the new Infant Formula Regulation. Contribute to the development of research projects, including new methods, aligned with the Human Food Program (HFP) Nutrition Strategic Plan. Provide guidance to staff, as needed, on preparation of Research Scientist Peer Review packages for promotion. Work with staff on the preparation of single and multi-laboratory validation protocols, and review and evaluation of data from method development projects, and single and multi-laboratory validation studies Draft public health risk reports and safety assessments to support FDA risk communication and compliance efforts. Work closely with the Project Officer throughout the project; provide project updates, monthly status reports and risk\issue resolution support. What You Will Need: Master's or PhD in Biochemistry, Chemistry, Food Science, Pharmacology, or a closely related field is required. 6-8 years of experience specialization in Protein Chemistry, Bioavailability, Nutritional Biochemistry and Food Science. Extensive experience in food ingredient safety assessment, risk evaluation, validation studies and regulatory compliance (e.g. FDA, PER Studies, food additives). Experience with regulatory submissions, risk prioritization, and public health risk reporting. Demonstrated ability to conduct literature reviews, analyze scientific data, methods, and synthesize findings for regulatory impacts and publications. Strong project management and technical writing skills Ability to work collaboratively with multidisciplinary teams and communicate complex scientific concepts to diverse audiences. Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD. What Would Be