Regulatory Food Safety Microbiology SME
Guidehouse•Silver Spring, MD
•Remote
About The Position
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.
Requirements
- 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.
Nice To Haves
- Candidates with an active public trust or suitability are preferred
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
