Rodrigo Gabriel Simas

- Conduct internal technology transfer projects for mRNA production. - Write strategic process documents including Manufacturing Process Descriptions and Process Risk Assessments. - Develop verification strategies for electronic Master Batch Records (eMBR) in PAS-X.

- Authored and reviewed GMP documentation (SOPs, risk assessments, qualification protocols). - Supported qualification and acceptance testing (HLRA, URS, FAT, HDS/SDS) of customized liquid-handling systems. - Contributed to the installation and digital integration of manufacturing equipment, ensuring seamless connection to automation systems, data historians, label printing, and SAP. - Participated in the planning and execution of the first end-to-end testing at the manufacturing site. - Supported and train

- Led industrial process development projects for biologics manufacturing (Bacterial and viral vaccines) - Troubleshot manufacturing processes and provided technical support to QC, QA, Supply, and Production. - Authored and revised GMP documentation and implemented an electronic documentation management system (Ennov). - Supported material/equipment acquisition and conducted personnel training for new technologies.

- Led a team of operators during the start-up of a monoclonal antibody manufacturing site. - Authored and reviewed GMP documents (batch records, SOPs, technical reports). - Executed SAT and IQ/OQ tests for perfusion bioreactors and upstream systems. - Collaborated on the design and automation of mixing systems with engineering and automation teams. - Participated in international technology transfer meetings.

- Developed a downstream purification process for a capsular polysaccharide used in vaccine formulation. - Designed and optimized tangential flow filtration (TFF) systems. - Operated and maintained TFF units. - Operated and maintained bench scale bioreactors. - Provided technical support to fermentation processes in a GMP pilot plant. - Operated and maintained HPLC systems.

Internship at the GMP facility for manufacturing the liquid and semi-solid formulations.

Double PhD with King's College London. Thesis: L-asparaginase production by recombinant Escherichia coli in high cell density cultivation for a pharmaceutical application

Double PhD with Universidade de São Paulo. Thesis: L-asparaginase production by recombinant Escherichia coli in high cell density cultivation for a pharmaceutical application

Thesis title: Study of the Polyribosyl-Ribitol-Phosphate precipitation mechanism in presence of salts and organic solvents