Senior Principal Scientist
Current- Project management for more than 70 clients in the pharmaceutical sector, including small, medium and large Brazilian companies and multinational companies;- Preparation of more than 100 qualification reports (according to ICH) on drug degradation products and API impurities to comply with Anvisa regulations;- Assessment of the toxicity of molecules and prediction of degradation via in silico software in order to mitigate in vitro or in vivo studies- More than 100 reports submitted and all successfully approved by the regulatory agency Anvisa, which is known to be one of the most demanding authorities in the global pharmaceutical sector;- Risk assessment of nitrosamines in APIs and finished products;- Risk Assessment of extractable and leachable impurities in finished producta- Team leadership of 11 scientific researchers- Training on development and validation of bioanalytical methods for more than 100 people