Boston, Massachusetts, United States
Life Sciences Professional & PMP® with over 19 years of expertise in the full lifecycle of assay development—from proof-of-concept to commercial product launch. Specialized in In Vitro Diagnostics (IVD) and multiplexed assays for autoimmune diseases and immuno-oncology. · Regulatory Success: Successfully led validation studies for FDA 510(k) clearance and Health Canada submissions in ISO 9001 / 13485 / GMP / GLP environments. · Product Development: Played a key role in the R&D and commercialization of CyTOF reagents and instruments. · Technical Expertise : Extensive hands-on experience developing validation protocols for Flow Cytometry, Mass Cytometry, and spatial proteomics multiplex imaging platforms.
In my role at Novartis, I led the strategic implementation of advanced proteomics platforms in single-cell and spatial biology, significantly enhancing our research capabilities in Immuno-Oncology, Hematology and Translational Research. I collaborated with various Disease Area groups to develop comprehensive CyTOF antibodies panels, which improved our understanding of critical biological pathways. My skills in training and maintaining the CyTOF XT platform ensured efficient operations and high-quality data output.
In my role as Laboratory Manager and Research Associate II within the Proteomics and Reagents R&D departments, I leveraged the immunological profiling and phenotyping of PBMCs and whole blood donors, developed advanced multiplexed metal-tagged antibody panels across next-generation mass cytometry platforms, including CyTOF® Helios, XT™, and the Hyperion™ Imaging System. I collaborated cross-functionally with academic institutions to pioneer and test innovative antibody conjugation techniques—such as UV-protein crosslinkers, nanoparticles, and aptamers—directly improving immunoassay sensitivity and specificity. My skills in advanced computational data analysis enabled me to process complex, high-dimensional FCS data files, utilizing manual gating alongside automated clustering and dimensionality reduction algorithms to resolve rare cellular subsets. My dedication to operational excellence and compliance guided the management of a shared Biosafety Level 2 (BSL-2) tissue culture facility. By establishing rigorous written operating procedures and maintaining top-tier organization, I successfully bridged communication and workflows between the R&D and Manufacturing teams to sustain peak laboratory operations and accelerate new product development. .
In my role within the Assay Development department, I drove the design and execution of in vitro diagnostic (IVD) kits for complex autoimmune diseases, successfully contributing to the regulatory US and Canada approval and market clearance of three new diagnostic products. I collaborated cross-functionally to develop and optimize highly multiplexed planar protein microarrays for antibody isotype detection (Ig_plex), as well as multi-plex cytokine assays within the Discovery division. My skills in executing rigorous verification and validation studies—coupled with a strong foundation in biochemistry for immunoassays optimization and dye-protein conjugation—ensured strict compliance with FDA 510(k) and Health Canada regulatory submissions while maintaining peak laboratory operations.
At Sanofi Pasteur Ltd., I contributed to the Research and Development division by developing and qualifying analytical assays for various vaccine candidates (TroVax, Streptoccocus Pneumoniae, BCG, Herpes). My role involved optimizing cell culture processes and designing PCR assays, all while adhering to stringent GMP/GLP standards. I also utilized my bilingual skills to facilitate communication by translating technical documents, ensuring clarity and precision in laboratory operations.
Infections and Cancer Biology laboratory training on the role of the oncoproteins E6 and E7 of the cutaneous human papillomavirus in the cellular transformation of primary keratinocytes. Competencies and skills: - Cell Biology: 293T cell culture, Human primary keratinocytes cell culture, RNA interference and oncogene plasmids transfections. - Molecular Biology: Plasmids Maxiprep for transfection, designing or primers, quantitative RT-PCR for RNA level expression, Western Blot for protein level expression.