The E&L Specialist is responsible for designing, executing, and reviewing scientific studies that assess the safety of materials used in pharmaceutical products, medical devices, and packaging systems. This role ensures compliance with regulatory expectations, supports product development, and contributes to risk assessments by providing high‑quality analytical data on extractables and leachables, N-Nitrosamines or Elemental Impurities.
Key Responsibilities:
Develop and execute Extractables and Leachables studies for raw materials, packaging components, single-use systems, and drug products.
Design study protocols based on regulatory guidelines (USP, ISO, EMA, FDA) and product-specific risk assessments.
Perform analytical testing using techniques such as GC-MS, LC-MS, ICP-MS, and headspace analysis.
Interpret analytical data, identify unknown compounds, and provide toxicological relevance in collaboration with toxicology experts.
Prepare and review technical reports, study protocols, and regulatory submission documents.
Support investigations related to material compatibility and potential product contamination.
Collaborate with Quality, R&D, Manufacturing, and Regulatory Affairs teams to ensure compliant and timely study execution.
Maintain up-to‑date knowledge of industry trends, regulatory updates, and best practices in E&L testing.
Ensure laboratory practices meet GMP, GLP, and internal quality standards.Key Competencies:
Analytical thinking and attention to detail.
Technical expertise in chromatography and mass spectrometry.
Strong communication and technical writing skills.
Ability to work collaboratively.
Project and time management.