Regulatory Food Safety Microbiology SME
Guidehouse · United States · 1mo ago
Job Family:
Scientist
Travel Required:
Clearance Required:
Our federal client is responsible for protecting public health through the scientific evaluation and regulatory oversight of dietary supplements. Guidehouse is seeking experienced Microbiology 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 microbiological safety assessments and risk characterization of dietary ingredients and dietary supplement products.
- Review and evaluate New Dietary Ingredient Notification (NDIN) submissions.
- Evaluate microbiological characterization and testing data.
- Review scientific literature, perform evidence assessments and ingredient prioritization reviews.
- Support microbiological safety assessments and exposure evaluations.
- Assess bacterial, yeast, mold, and microbial contamination data.
- Compile annotated bibliographies and literature summaries; Prepare scientific memoranda, reports, and regulatory review documentation.
- Participate in NDIN review activities involving microbial ingredients.
- 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:
- M.S. or Ph.D. in Microbiology, Molecular Biology, or related scientific disciplines.
- Minimum ZERO-TWO (0-2) years of prior relevant experience
- Experience with microbiological testing and characterization methodologies.
- Experience evaluating scientific literature and data quality.
- Experience supporting microbiological risk assessments.
- Knowledge of microbial identification techniques.
- Strong technical 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 preferred
What 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.
- Experience with genomic sequencing methods.
- Experience evaluating antimicrobial resistance, spore-forming organisms and/or microbial toxins.
- Experience preparing regulatory science memoranda, regulatory science reports and policy-supporting analyses.
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.
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.
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