Regulatory Infant Food Scientist

Scientist


Up to 10%


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.

• 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• Develop draft guidance for conduct and evaluation of protein efficiency ratio and growth monitoring studies in infant formula submissions;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.

• 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.

• 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.

The annual salary range for this position is $98,000.00-$163,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.



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

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.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.