Regulatory Food Safety Toxicology SME

Summary

Job Family: Scientist Travel Required: Up to 10% Clearance Required: Ability to Obtain Public Trust Our federal client is responsible for protecting public health through the scientific evaluation and regulatory oversight of dietary supplements. Guidehouse is seeking experienced Toxicology Subject Matter Experts to conduct safety evaluations of dietary ingredients and dietary supplement products, perform risk assessments, evaluate scientific evidence, and prepare technically defensible reports supporting FDA regulatory review activities.What You Will Do: Conduct safety assessments and risk characterization of dietary ingredients and dietary supplement products.Review and evaluate New Dietary Ingredient Notification (NDIN) submissions.Perform systematic literature reviews and evaluate scientific data quality.Integrate information from multiple scientific sources to support evidence-based conclusions.Conduct dose-response analyses and apply toxicological risk assessment methodologies.Prepare technical memoranda, scientific reports, and regulatory review documents.Develop data gap analyses and annotated bibliographies.Support ingredient prioritization and safety review activities.Utilize FDA databases, scientific literature repositories, and toxicological assessment tools.Present scientific findings and recommendations to reviewers and technical specialists.Complete all required corporate, client, safety, security, and laboratory training requirements.What You Will Need: Ph.D. in Toxicology, Pharmacology or a related scientific disciplines.Minimum ZERO- TWO (0-2) years of prior relevant experienceDemonstrated experience conducting toxicology-based safety assessments.Experience performing risk characterization and hazard evaluations.Experience conducting literature reviews and evidence synthesis.Strong analytical, scientific writing, and communication skills.Ability to work independently assess complex scientific data and prepare technical reports.Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse.Candidates with an active public trust or suitability are preferredWhat Would Be Nice To Have: Experience supporting FDA, USDA, CDC, public health, food safety, or other regulatory laboratory programs.Dietary supplement or food safety regulatory review (I.e. NDIN) experience.Familiarity with FDA guidance documents and review processes.Experience using systematic review methodologies.Experience preparing regulatory science memoranda, regulatory science reports and policy-supporting analyses.The annual salary range for this position is $65,000.00-$108,000.00. 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: MedicalRxDental & Vision InsurancePersonal and Family Sick Time & Company Paid HolidaysParental Leave401(k) Retirement PlanGroup Term Life and Travel AssistanceVoluntary Life and AD&D InsuranceHealth Savings AccountHealth Care & Dependent CareFlexible Spending AccountsTransit and Parking Commuter BenefitsShort-Term & Long-Term DisabilityTuition ReimbursementPersonal DevelopmentCertifications & Learning OpportunitiesEmployee Referral ProgramCorporate Sponsored Events & Community OutreachCare.com annual membershipEmployee Assistance ProgramSupplemental 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 bonusAbout 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.Guidehouse is a global AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future. guidehouse.com#J-18808-Ljbffr

Job Description

Job Family: Scientist Travel Required: Up to 10% Clearance Required: Ability to Obtain Public Trust Our federal client is responsible for protecting public health through the scientific evaluation and regulatory oversight of dietary supplements. Guidehouse is seeking experienced Toxicology Subject Matter Experts to conduct safety evaluations of dietary ingredients and dietary supplement products, perform risk assessments, evaluate scientific evidence, and prepare technically defensible reports supporting FDA regulatory review activities.What You Will Do: Conduct safety assessments and risk characterization of dietary ingredients and dietary supplement products.Review and evaluate New Dietary Ingredient Notification (NDIN) submissions.Perform systematic literature reviews and evaluate scientific data quality.Integrate information from multiple scientific sources to support evidence-based conclusions.Conduct dose-response analyses and apply toxicological risk assessment methodologies.Prepare technical memoranda, scientific reports, and regulatory review documents.Develop data gap analyses and annotated bibliographies.Support ingredient prioritization and safety review activities.Utilize FDA databases, scientific literature repositories, and toxicological assessment tools.Present scientific findings and recommendations to reviewers and technical specialists.Complete all required corporate, client, safety, security, and laboratory training requirements.What You Will Need: Ph.D. in Toxicology, Pharmacology or a related scientific disciplines.Minimum ZERO- TWO (0-2) years of prior relevant experienceDemonstrated experience conducting toxicology-based safety assessments.Experience performing risk characterization and hazard evaluations.Experience conducting literature reviews and evidence synthesis.Strong analytical, scientific writing, and communication skills.Ability to work independently assess complex scientific data and prepare technical reports.Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse.Candidates with an active public trust or suitability are preferredWhat Would Be Nice To Have: Experience supporting FDA, USDA, CDC, public health, food safety, or other regulatory laboratory programs.Dietary supplement or food safety regulatory review (I.e. NDIN) experience.Familiarity with FDA guidance documents and review processes.Experience using systematic review methodologies.Experience preparing regulatory science memoranda, regulatory science reports and policy-supporting analyses.The annual salary range for this position is $65,000.00-$108,000.00. 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: MedicalRxDental & Vision InsurancePersonal and Family Sick Time & Company Paid HolidaysParental Leave401(k) Retirement PlanGroup Term Life and Travel AssistanceVoluntary Life and AD&D InsuranceHealth Savings AccountHealth Care & Dependent CareFlexible Spending AccountsTransit and Parking Commuter BenefitsShort-Term & Long-Term DisabilityTuition ReimbursementPersonal DevelopmentCertifications & Learning OpportunitiesEmployee Referral ProgramCorporate Sponsored Events & Community OutreachCare.com annual membershipEmployee Assistance ProgramSupplemental 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 bonusAbout 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.Guidehouse is a global AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future. guidehouse.com#J-18808-Ljbffr