Biomarker Development with demonstrated experience in Immunology preclinical and clinical phase projects. Development and implementation of biomarkers to foster science and data-driven decision making.I specialize in DNA identification systems, especially in the use of next-generation sequencing (NGS) platforms. In my current work, I use NGS platforms for the characterization of biopharmaceutical candidates, including viral vectors for gene therapy and cell lines. In my previous roles, I had the experience of using NGS technology for product authentication and the diagnosis of viral pathogens. I also develop real-time PCR assays through genome skimming and comparative genomics. In addition to laboratory experience, I also have practical knowledge of building genome assemblies and analyzing genomes using various bioinformatics tools.
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Senior Principal Scientist - Translational Biology & BioanalyticalGenentech Sep 2022 - Jan 2023Boston, Massachusetts, Estados Unidos- Led the development, validation, and transfer of GLP NAb assays to CROs for AAV based gene therapies - Produced data package for PK/PD modeling that included cell binding, receptor occupancy & internalization kinetics- Provided support for pre-IND studies in both rare disease and autoimmune disease related programs- Trained Scientists on dPCR/ddPCR instruments, developed protocols for routine viral titer assessments - Investigated the presence of antigen specific T-cells subsets in PBMCs of ImmTOR treated clinical samples - Other responsibilities include MSD ELISA assays, cell culture, documentation and CRO communications- -
Scientist Ii - Ngs And Biomarker DevelopmentGenentech Jul 2021 - Sep 2022Boston, Massachusetts, Estados Unidos -
Diagnostic AnalystRoche Oct 2018 - Jul 2021 -
Diagnostic AnalystBio-Manguinhos / Fiocruz Jan 2021 - Jun 2021Rio De Janeiro, Brasil -
Scientific ResearcherUniversidade Federal Do Rio De Janeiro Feb 2010 - Sep 2018
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Carla Bandeira de Mello e S. Baptista
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Carla Gabriela S. Fernandes
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