Sudip Saha
Senior Bioassay Scientist @Xzom, Inc
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WORK HISTORY
Senior Bioassay Scientist @Xzom, Inc
San Diego, CA, US
Lead scientist in bioassay development and system integration for multiplexed cancer diagnostics. Directed assay design and optimization using antibodies, aptamers, and fluorophores for clinical-grade performance. Led the end-to-end development and optimization of high-complexity immunoassay and nucleic-acid based assay. Oversee designing and developing multiple new biomarker assays that worked with the device. Led a cross-functional team to establish orthogonal validation between electrokinetic andimmunoassay-based platforms. Drove bioassay calibration strategies and sensitivity optimization, improving signal reproducibility andreducing variability by 50%. Championed statistical modeling of limit-of-detection (LOD) and method comparison studies using JMP analytics. Created and executed assay development plans and milestones that are required for successfulimplementation. Defined assay validation and verification protocols under design control for clinical readiness. Translated lab assay methods into commercial assay workflows with single-use cartridge. Mentored junior engineers and scientists in assay troubleshooting, DOE, and process characterization. Successfully developed and optimized >5 protein biomarker assays achieving clinically relevant sensitivity and <15% CV, meeting stringent diagnostic requirements. performed proteomics analysis using proprietary system and compared with orthogonal approach from patient plasma.
EDUCATION
McMaster University
Doctor of Philosophy - PhD, Bioengineering and Biomedical Engineering
McMaster University
M.A.Sc, Engineering Physics
Notredame College
Higher Secondary Certificate, Science
Bangladesh University of Engineering and Technology
Bachelor's degree, Electrical and Electronics Engineering
SKILLS
ABOUT SUDIP SAHA
Visionary scientist and assay development leader with extensive experience advancing biosensor technologies and diagnostic assay platforms from concept to clinical validation. Known for driving innovation across bioassay design, process optimization, and system integration to deliver clinically impactful solutions. Demonstrated success in leading cross-functional teams, improving assay robustness, and translating complex R&D initiatives into scalable diagnostic products
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