Regulatory Food Safety Microbiology SME

Microbiology Subject Matter Expert

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Silver Spring, MD Public Trust Polygraph Unspecified Career Level not specified $65,000 - $108,000

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 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.

The annual salary range for this position is $65,000.00-$. 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 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
• annual membership
• Employee Assistance Program
• Supplemental Benefits via…