Chemist Specializing in Extractable and Leachable Analysis
Extractable and Leachable evaluations are vital to thorough and successful product development, and regulatory submissions for pharmaceutical and biopharmaceutical products. Product contact manufacturing components such as tubing, couplings, seals and gaskets, diaphragms, bladders, etc., must all be evaluated for such extractables and leachables during the developmental phase of a drug product. A candidate must have experience in LCMS and GCMS methods, among others, for extractables and leachables analysis of polymeric materials used in the manufacture of pharmaceuticals, and biopharmaceuticals. Experience and understanding of USP <665> and <1665>, and <661>, and the test methods therein is required. Candidate must possess the ability to advise Business Development and Sponsors of the requirements of extractables and leachables analysis.