Perform Extractables & Leachables (E&L) studies in line with BPOG and regulatory guidelines (USP , , ICH Q3D).Operate and maintain instruments like LC-MS/MS, GC-MS/MS, UHPLC, GC-FID.Conduct method development, optimization, and validation for targeted and non-targeted analysis.Interpret mass spectral, elemental, and chromatographic data for accurate reporting.Support wet chemistry tests (pH, conductivity, titrations) and documentation activities.Prepare/review SOPs and validation reports, ensuring compliance with GLP, NABL, 21 CFR Part 11, and US FDA requirements.Experience in Nitrosamines, PFAS, Bisphenol A, and unknown screening is preferred.
