Subject Matter Expert II

Role: Subject Matter Expert II [Domain: (Analytical, organic, or inorganic chemistry experience with extensive knowledge of cosmetics manufacturing industry)]

Location: DMV (On-site in metro-based area)

Duration: 6+ Months Contract

Visa: US Citizen




Note : Prefer candidates in DMV area, however, FDA is open to considering highly qualified candidates outside the area.

Job Summary:

Provide scientific and technical support to FDA's cosmetics program. The role applies chemistry and manufacturing expertise across GMP evaluation, compliance and risk assessment, tool development, and policy support. FDA is specifically looking to broaden its bench - the team already has deep in-house formulation expertise, so candidates whose experience spans manufacturing operations, quality, safety, and regulatory functions are prioritized over formulation-centric profiles.

Task 1- Good Manufacturing Practices (GMP)

Apply chemistry, manufacturing, and process knowledge across development, scale-up, production, and analytical specifications to support FDA's interpretation of safety-related information. Emphasis on manufacturing controls, process understanding, and analytical/specification review.

Task 2- Compliance and Risk Assessments:

• • • Utilizes existing chemistry knowledge and skills to support compliance assignments and risk assessment efforts of cosmetic products and ingredients using facility, listing and adverse event data available to the FDA.

Task 3- Identification and Development of Tools:

• • • Assist with the development of tools to assess the ability to use chemical information provided in Cosmetic Registration and Listing programs to help identify ingredients and products.

Task 4- Chemical Identity of Cosmetic Products:

• • • Assist with recommendations for challenges in the product listing for cosmetics, such as the lack of necessary information including product labels and product ingredients in the adverse event reports.

Task 5- Guidance and Policies:

• • • Provide scientific support towards the development of any guidance or policies related to good manufacturing practices in cosmetic industry

Required experience:

• BS 10yrs / MS 6yrs

Preferred Experience:

At minimum 3 5 years of hands-on industry experience in one or more of the following. Depth across multiple areas is what FDA is after:

• Research & Development
• Product safety / toxicology / safety substantiation
• Food, drug, or cosmetics manufacturing operations
• Process development and scale-up
• QA/QC - including analytical method validation, stability, batch release, supplier quality

Regulatory compliance - GMP audits, inspection readiness, registration and listing, labeling review