Extractables & Leachables (E&L) Analyst

Design and execute extractables & leachables (E&L) studies for container-closure systems, packaging and medical devices using GC-MS, LC-MS/MS and ICP-MS, ensuring scientifically sound, data-integral E&L data aligned to USP <1663>/<1664>, ISO 10993, PQRI and regulatory expectations. Key responsibilities: design and execute E&L study protocols for container-closure systems, packaging, devices and process materials; perform controlled extraction studies and leachables analysis on drug product/simulants; analyse samples by GC-MS, LC-MS/MS, ICP-MS and headspace for organic, inorganic and volatile species; identify and quantify extractables/leachables with structural elucidation and library matching; apply the Analytical Evaluation Threshold (AET) and toxicological/safety-threshold concepts with QA/Tox; develop and validate E&L methods and manage reference standards/surrogates; compile E&L study reports for regulatory submissions (USP <1663>/<1664>, ISO 10993, PQRI); record raw data, spectra and interpretations contemporaneously (ALCOA++); and support internal, NABL, FDA and client audits. Grade LM-4 | Individual Contributor / Specialist | Division: Analytical (Analytical Chemistry – Extractables & Leachables) | Education: M.Sc (Chemistry/Analytical Chemistry) or M.Pharma | Experience: 6–10 years in E&L / trace-organic analysis | Reports to: Group Leader – Analytical.