SME II - Cosmetic Manufacturing & GMP
College Park, Maryland
Full time |

Position Overview

We are seeking a Subject Matter Expert II with analytical, organic, or inorganic chemistry experience and extensive knowledge of the cosmetics manufacturing industry. The SME will provide scientific support on Good Manufacturing Practices (GMP), chemical identity of cosmetic products, and the use of registration and listing data to support FDA compliance and risk assessment.



Requirements

Key Responsibilities

  • Good Manufacturing Practices (GMP): Apply chemistry expertise in development, scale-up, manufacturing, formulation, and analytical specifications to interpret FDA data as it relates to product safety.
  • Compliance and Risk Assessments: Use chemistry knowledge to support compliance assignments and risk assessments of cosmetic products and ingredients, drawing on facility, listing, and adverse event data.
  • Tool Identification and Development: Help develop tools that evaluate how chemical information submitted through Cosmetic Registration and Listing programs can be used to identify ingredients and products.
  • Chemical Identity of Cosmetic Products: Recommend solutions to product listing challenges, such as missing labels or ingredient information in adverse event reports. Prepare the monthly deliverable in Microsoft Word format for electronic submission to the COR.
  • Guidance and Policy Support: Provide scientific input to guidance and policy development related to GMP in the cosmetics industry.
  • Prepare monthly deliverables for the COR documenting work performed and findings.

Required Qualifications

  • Bachelors, Master's or Ph.D. in Analytical, Organic, or Inorganic Chemistry, or a related field
  • 5-7 of relevant experience, with significant experience in the cosmetics manufacturing industry
  • In-depth knowledge of cosmetic GMP principles and manufacturing processes
  • Experience with analytical methods and product specifications
  • Ability to evaluate chemical identity and composition of cosmetic products from incomplete data
  • Strong technical writing skills and the ability to produce polished Word documents
  • Proficiency with Microsoft Office


Benefits

  • PPO/HMO Health Plan (includes medical, dental, and vision)
  • 401K Retirement Plan
  • Paid Time Off (PTO)