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Guidehouse

Advises agencies and runs regulated operations

Regulatory Food Safety Microbiology SME

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSilver Spring, MD, USA

About the Job

Requirements

  • A Master of Science or Ph.D. in Microbiology, Molecular Biology, or a related scientific discipline.
  • Zero to two 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 Department of Defense public trust; approved adjudication is required before onboarding. Candidates with an active public trust or suitability are preferred.

Responsibilities

  • Conduct microbiological safety assessments and risk characterization of dietary ingredients and dietary supplement products.
  • Review and evaluate New Dietary Ingredient Notification submissions.
  • Evaluate microbiological characterization and testing data.
  • Review scientific literature, perform evidence assessments, and conduct 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 New Dietary Ingredient Notification review activities involving microbial ingredients.
  • Use FDA databases, scientific literature repositories, and toxicological assessment tools.
  • Present scientific findings and recommendations to reviewers and technical specialists.
  • Complete required corporate, client, safety, security, and laboratory training.

Desired Qualifications

  • Experience supporting FDA, USDA, CDC, public health, food safety, or other regulatory laboratory programs.
  • Dietary supplement or food safety regulatory review experience, such as New Dietary Ingredient Notification 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.

About the Company

Guidehouse

Advises agencies and runs regulated operations

Guidehouse advises government agencies and companies in regulated industries on strategy, technology and day-to-day operations. Its work combines business advice with software implementation and ongoing management, so a client uses the same firm to plan a change, build the systems and run the resulting processes. Teams modernize cloud platforms, apply data analysis and artificial intelligence, and redesign organizations to meet operating and regulatory requirements. Clients pay for consulting projects and technology work or outsource continuing business functions to its managed services teams. Guidehouse was founded in 2018 and is headquartered in McLean, Virginia.

Company size
10,001+
Company stage
Acquired
Total funding
$750K
Headquarters
McLean, VA
Founded
2018

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