Functional Expert Consultant I - Microbiologist
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The purpose of this task order is to identify candidates with demonstrated expertise in dietary supplement technical and
regulatory science spanning identity assessment, safety assessment, labeling review, and manufacturing evaluation. The scope of work is as follows:
- Identity & Safety Assessment: Use scientific expertise and principles to complete and aid in identity and safety
assessments of dietary ingredients and supplements; review work will include assessment of pre-market and post-market data on single ingredients, complex mixtures, and/or finished dietary supplement products. The candidate for Microbiology position will be expected to use knowledge in microbiological characterization and testing to evaluate the identity of microbials and assist in exposure assessments and risk assessments for microbiological organisms in and as dietary ingredients.The candidate will not be asked to comment on or contribute to policy decisions related to dietary ingredients and supplements. - Labeling & Manufacturing Review: Evaluation of product labels, labeling claims, and manufacturing processes to determine compliance with applicable regulations and policies
The FDA is seeking a Functional Expert Consultant I – Dietary Supplement Identity & Safety Assessment with an M.S. or Ph.D. in Microbiology.
All contractors shall work independently and demonstrate subject matter expertise in assessment methods, data
evaluation, regulatory science applications and dietary supplement regulatory requirements. At a minimum, contractors
shall possess demonstrated competencies or transferable skills in the areas relevant to their discipline, as outlined below.
Requirements
Requirements and Essential Duties:
- Traditional microbiological methods such as sampling and sample preparation, aerobic microbial counts, yeast/mold
counts, Salmonella/E. coli evaluation - Advanced microbiological techniques such as sequencing/genetic methods, antimicrobial resistance evaluation, spore (and toxin) detection
- Performing comprehensive searches (e.g., peer reviewed publications; marketing evaluation)
- Literature review and data quality evaluation
- Scientific communication and report preparation
Specific Tasks
Tasks are organized by functional area below. A rationale should be provided with evidence to support any recommendations unless task instructions explicitly exclude this requirement.
- NDIN Assessment – identity evaluation and safety/risk assessment of data for new dietary ingredients; requires subject matter expertise, data integration skills, collaboration with other SMEs, regular updates/summaries to mentor/supervisor, and a written report per prepared templates; milestones at day 15 (preliminary review), day 30 (intermediate review), day 50 (report due), with weekly/biweekly check-ins
- Ingredient Review of Prioritization – identity evaluation (microbiologist) and safety assessment (microbiologist and toxicologist) of a dietary ingredient to identify priority candidates for identity/safety review and regulatory action; includes review of peer-reviewed literature, industry reports, product labels, and database resources, summarized in a memo; milestones range from 1 day to 2 weeks per assignment
- Prepare Data Gap Analyses – data gap analyses for assigned ingredients or product categories; assist in creating prioritization frameworks for research needs
- Compile Annotated Bibliographies – annotated bibliographies with critical evaluations from peer-reviewed publications, industry reports, and governmental/intergovernmental organization studies
- Develop Standardized Evaluation Tools and Checklists – explore/develop standardized evaluation tools and checklists to improve review consistency; criteria vary by discipline and capture reviewer-relevant parameters
- Identity or Risk Analysis – identity evaluation (microbiologist) or safety assessment (toxicologist, microbiologist, or both) of dietary ingredients or finished supplements to inform FDA
- Labeling Evaluation Related to Inspection Findings – evaluate product labels/labeling information from inspections; prepare written memo documenting findings, regulatory assessments, and conclusions
- Issue Dietary Supplement Export Certificates Based on Labeling Information – review product label/labeling, determine compliance status, and issue export certificates per applicable regulatory requirements
- Evaluate Claims in Structure Function Claim Notifications (SFCN) and Draft Objection Letters if Needed – evaluate SFCN claims for statutory/regulatory compliance; prepare objection letters when disease claims or other non-compliant issues are identified
- Market Surveillance and Support for Regulatory Actions – conduct market surveillance for potentially violative dietary supplement products; document findings, prepare review memoranda, recommend regulatory/compliance actions, coordinate with FDA offices on enforcement
- Evaluate Dietary Supplement Manufacturing Processes – evaluate manufacturing processes against CGMP requirements based on inspectional findings; document violations, prepare review memoranda, propose language for warning letters/correspondence
Benefits
- PPO/HMO Health Plan (includes medical, dental, and vision)
- 401K Retirement Plan
- Paid Time Off (PTO)