Senior Scientist IV

Job Family:

IT Project Management (Digital)

Travel Required:

Up to 25%

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:

• Lead proactive surveillance and safety assessment of self-determined Generally Recognized as Safe (GRAS) food ingredients in anticipation of a transition to a mandatory pre-market GRAS regulatory process.

• Develop and implement reproducible methodologies for surveying publicly available information to identify substances claimed as self-GRAS, including trade press and public announcements.

• Build and maintain a comprehensive database of self-GRAS substances, documenting market presence, supporting evidence, safety information, and relevant regulatory records.

• Prepare detailed surveillance methodology and findings reports suitable for publication in peer-reviewed scientific journals.

• Evaluate and prioritize substances currently on the U.S. market for public health relevance, justifying prioritization decisions in formal reports.

• Conduct safety assessments of high-priority substances, synthesizing information from regulatory authorities (e.g., JECFA, EFSA, Health Canada), scientific literature, adverse event reports, and historical consumption data.

• Draft public health risk reports and safety assessments to support FDA risk communication and compliance efforts.

• Collaborate with FDA staff and other contractors to ensure sound judgment in prioritization and safety assessment decisions.

• Present methodology, database, and findings to the FDA at key milestones, both virtually and in-person at the College Park, MD campus.

• Ensure all deliverables and electronic content meet Section 508 accessibility standards.

• What You Will Need:

• A PhD in Toxicology, Pharmacology, Chemistry, Food Science, or a closely related field is required

• A Minimum of TEN (10) years of experience

• U.S. citizenship or legal authorization to work for the FDA is required

• Extensive experience in food ingredient safety assessment, toxicological risk evaluation, and regulatory compliance (FDA, GRAS, food additives).

• Demonstrated ability to conduct literature reviews, analyze scientific data, and synthesize findings for publication.

• Experience with regulatory submissions, risk prioritization, and public health risk reporting.

• Strong project management and technical writing skills, with a track record of producing peer-reviewed publications.

• Proficiency in database development and management (e.g., SharePoint, Excel).

• Ability to work collaboratively with multidisciplinary teams and communicate complex scientific concepts to diverse audiences.

What Would Be Nice To Have:

• Prior experience supporting FDA, USDA, or other regulatory agencies on GRAS or food additive safety projects.

• Familiarity with international food safety standards and regulatory authorities (JECFA, EFSA, Health Canada, FSANZ).

• Experience with social media listening and alternative data sources for safety surveillance.

• Knowledge of Section 508 compliance and electronic content accessibility standards.

• Experience presenting scientific findings to regulatory agencies and at professional conferences.

• Advanced skills in data analysis tools (e.g., PubMed, Google Scholar, statistical software).

• Experience with FDA’s Food Applications Regulatory Management (FARM) System and the FDA network resources.

The annual salary range for this position is $171,000.00-$285,000.00. 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.

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 Leav