SME II (Analytical/Cosmetic Manufacturing Chemist)

SCOPE: Cis seeking an Analytical/Cosmetic Manufacturing Chemist with deep chemistry expertise in pharmaceutical sciences and botanicals as applied to the cosmetic industry. This role provides scientific support to FDA efforts around cosmetic product registration, listing, ingredient safety assessment, adverse event analysis, and the development of tools, guidance, and policies that strengthen cosmetic product safety oversight. The SME will translate hands-on knowledge of cosmetic formulation, manufacturing, and analytical chemistry into actionable scientific interpretation of regulatory data. REQUIRED SKILLS:

• Bachelor's degree in Analytical Chemistry, Organic Chemistry, Inorganic Chemistry, or a closely related scientific discipline. Advanced degree (MS/PhD) strongly preferred.
• Minimum of 7 years of progressive experience in cosmetics or personal care product manufacturing, with demonstrated depth across analytical method development, formulation chemistry, and GMP environments.
• Working knowledge of FDA regulatory frameworks governing cosmetics manufacturing, including MoCRA requirements and applicable GMP guidance (e.g., ISO 22716 alignment).
• Demonstrated ability to interpret analytical chemistry data and manufacturing records to support compliance and risk assessment conclusions.
• Strong written and verbal communication skills, with the ability to translate technical chemistry and manufacturing concepts for regulatory and policy audiences.
  
  

Preferred Skills

• Prior experience supporting FDA, CFSAN, or another federal regulatory body in a scientific advisory capacity.
• Experience with cosmetic facility inspections, GMP audits, or quality systems implementation in a cosmetics manufacturing setting.
• Familiarity with adverse event databases (e.g., CAERS) and product listing systems.
• Experience contributing to regulatory guidance, policy documents, or industry best-practice publications.
• Background in tool or data system development supporting chemical identification or regulatory science workflows.
  
  

Tasks

• Apply chemistry expertise across development, scale-up, manufacturing, product formulation, and analytical specifications to interpret information available to the FDA as it relates to cosmetic product safety data.
• Provide scientific input on GMP-related considerations affecting compliance and risk posture.
• Apply analytical and manufacturing chemistry knowledge to support compliance assignments and risk assessment of cosmetic products and ingredients, drawing on facility data, product listings, and adverse event information available to the FDA.
• Support the development of tools that assess how chemical information submitted through Cosmetic Registration and Listing programs can be used to identify ingredients and finished products with greater precision and consistency.
• Provide recommendations to address challenges in cosmetic product listings, including incomplete or missing information such as product labels and ingredient details in adverse event reports.
• Identify opportunities to improve the chemical identifiability of products in regulatory data systems.
• Provide scientific input toward the development of guidance documents and policies related to Good Manufacturing Practices in the cosmetics industry.