Job Family:
Scientist
Travel Required:
Clearance Required:
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○ Develop draft guidance for conduct and evaluation of protein efficiency ratio and growth monitoring studies in infant formula submissions;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 Nice To Have:
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.
What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
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.)
Position may be eligible for a discretionary variable incentive bonus
About Guidehouse
Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
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