Regulatory Infant Food Scientist

About the role

This position aids in the public health risk and safety assessments of infant formula submissions for a federal client. Key responsibilities include consulting on new requirements under the Infant Formula Final Rule, collaborating with regulatory staff, evaluating analytical methods, and developing guidance for protein efficiency ratio (PER) studies.

Responsibilities

• Provide consultative services on new Protein Efficiency Ratio (PER) requirements and other chemistry-specific areas of infant formula notifications.
• Evaluate analytical methods and protein quality issues.
• Evaluate infant formula notification requests for additional data and information regarding protein efficiency assays and bioassays for determining 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• Develop draft guidance for conduct and evaluation of protein efficiency ratio and growth monitoring studies in infant formula submissions.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 regarding 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 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 evaluate 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.

Requirements

• Master's or PhD in Biochemistry, Chemistry, Food Science, Pharmacology, or a closely related field is required.
• 6-8 years of experience specializing 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.

Qualifications

• Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.

Skills

• Prior experience supporting FDA, USDA, or other regulatory agencies on infant nutrition and food additive safety projects.
• Familiarity with international food safety standards and regulatory authorities (JECFA, EFSA, Health Canada, FSANZ).
• Experience presenting scientific findings to regulatory agencies and at professional conferences.

Benefits

• The annual salary range for this position is $98,000.00-$163,000.00.
• Benefits include Medical, Rx, Dental & Vision Insurance, Personal and Family Sick Time & Company Paid Holidays, Parental Leave, 401(k) Retirement Plan, Group Term Life and Travel Assistance, Voluntary Life and AD&D Insurance, Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts, Transit and Parking Commuter Benefits, Short-Term & Long-Term Disability, Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities, Employee Referral Program, Corporate Sponsored Events & Community Outreach, Care.com annual membership, Employee Assistance Program, Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.).

Pay

The annual salary range for this position is $98,000.00-$163,000.00.

Schedule

Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.