Regulatory Food Safety Microbiology SME

Guidehouse Inc.; Silver Spring (MD); On-site; USD 65,000 - 108,000; Full time

Benefits offered by this job

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Parental Leave

Transit and Parking Commuter Benefits

Tuition Reimbursement, Personal Dev.

Employee Referral Program

Employee Assistance Program

Discretionary incentive bonus

Job summary

Guidehouse is seeking a Scientist in Maryland to conduct microbiological safety assessments and evaluate NDIN submissions for dietary ingredients and supplements. The role involves data interpretation, literature reviews, and preparation of regulatory documentation.

The candidate will utilize toxicological tools and FDA databases to support risk assessments. The position requires an MS/PhD in microbiology or molecular biology, up to 2 years of relevant experience, strong writing skills, and the

Qualifications

• MS or PhD in Microbiology, Molecular Biology, or related field.
• 0–2 years of 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 and prepare technical reports.
• Must be able to obtain/maintain a Federal or DoD public trust.

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, 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.

Skills

Microbiology

Molecular Biology

Technical writing

Independent work

Data interpretation

Communication skills

Literature evaluation

Public trust knowledge

Regulatory reporting

Education

MS or PhD in Microbiology or Molecular Biology

Tools

Genomic sequencing methods

Job description

Job Family: Scientist

Travel Required: Up to 10%

Clearance Required: Ability to Obtain Public Trust

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-$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

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.

• 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.