Marco Antonio da Silva

I hold a Ph.D. in CHEMISTRY from the INSTITUTE OF CHEMISTRY (USP) (2001) and a higher education degree in TECHNOLOGY IN INDUSTRIAL PRODUCTION MANAGEMENT from UNICID (2023).I have a doctorate in the organic synthesis of new pharmacological molecules and the study of their stability. I have experience in both the academic field and the pharmaceutical industry. In academia, I actively participated in developing the new curriculum for the pharmacy course at Oswaldo Cruz Colleges and was part of the renowned research group of Prof. Dr. Liliana Marzorati and Prof. Dr. Blanka Wladislaw at the Institute of Chemistry USP, in the fields of Phase-Transfer Catalysis and the Synthesis of Sulfur-Containing Organic Compounds, respectively.I am a specialist in the organic synthesis of active pharmaceutical ingredients (APIs) and pharmacological molecules. I have experience in the pharmaceutical and chemical industries, having worked in the Chemical Research and Development Department of a leading national pharmaceutical company. My work involved researching, improving, and synthesizing a diverse range of molecules related to APIs and their synthetic intermediates used in the pharmaceutical industry. These molecules were associated with various medical research fields, such as gynecology (steroid synthesis), cardiovascular, neuropsychiatric, gastroenterological, infectious disease, respiratory, dermatological, urological, musculoskeletal, oncological, and immunosuppressive treatments. In the latter case, I participated in the technology transfer of an immunosuppressive molecule from a leading Indian company.I am a specialist in the preparation and evaluation of DMFs (Drug Master Files Open Part and Restricted Part), in compliance with regulatory standards established by COIFA (Coordination of Registration of Active Pharmaceutical Ingredients - https://www20.anvisa.gov.br/coifa/). My work follows current regulatory legal requirements (ANVISA) and international guidelines (ICH, EMA, FDA, etc.). Additionally, I actively evaluate organic impurities derived from synthesis and/or degradation, including genotoxicity aspects, risk management reports for N-nitrosamines, and elemental impurities.Furthermore, I have participated in all major stages of development and synthetic route (RoS) design for molecules in medium to high-complexity projects (API scope), from technical and economic feasibility studies to process implementation in the manufacturing plant. This includes pilot manufacturing, scale-up (optimization), and validation of industrial processes, all within Good Manufacturing Practices (GMP Quality Systems). In this regard, I am responsible for leading the technology transfer of these new products to the production area and providing technical support for existing processes in pharmaceutical chemical business units. My role ensures the expansion of the product portfolio and the identification of deviations in already implemented processes, proposing corrective and preventive actions.In this context, I also hold a Green Belt certification and apply concepts from Lean Manufacturing and Six Sigma Methodology (DoE, DMAIC, FMEA, PMPA, 5S philosophy, and Quality by Design concepts).Additionally, I have served as the Responsible Technical Chemist (RT) for a pharmaceutical chemical company, ensuring compliance with the legal requirements of the pharmaceutical chemical sector. This included supporting ANVISA inspections and regulatory actions by the Civil Police, Federal Police, and Army, ensuring adherence to legal requirements for controlled substances. Work on the Project National Platform for Biotechnological Pharmaceutical Products in partnership with the Institute of Science, Technology and Innovation Inventta and Blau Farmacêutica. (Source: Lattes Curriculum)