Analytical Chemistry Researcher
CurrentMember of R&D teams as Analytical Work Package Leader and as team member for projects related to pharmaceutical product formulations, submissions, on market activities, troubleshooting for manufacturing plants support. Knowledge of ICH, USP, EMA, FDA guidelines and requirements. National and international CROs and external partnerships management and support.Product support (development and on market): routine and troubleshooting analysis. Stability protocol drafting and application on intermediates, APIs and final products.Elemental analysis (ICP-OES, ICP-MS), infrared spectroscopy (FT-IR, micro-FT-IR), TOC, NMR (1H, 13C, 2D), thermogravimetric (TGA, TGA-IR) and HPLC analysis for pharmaceutical products; development and validation of analytical methods for drug products and APIs according with Pharmacopoeias; inorganic leachable and extractables studies according to international guidelines; bioanalytical methods for biological and animal matrices; development and validation of hyphenated techniques (HPLC-ICP-MS).Analytical support to R&D, Corporate Quality (methods development and transfer), Chemistry, Manufacturing and Controls (CMC) and Regulatory Affairs (for drug products submissions).
