Katya Suslova

Translational Biotechnology Expert | Molecular Diagnostics, Cell/Gene Therapy | Scientific Due Diligence & Innovation Strategy

San Diego, California, United States of America

Research Expertise

Translational Biotechnology
Molecular Diagnostics
Technology Evaluation
Scientific Due Diligence
Biosensor Platforms
Cell & Gene Therapy
Precision Medicine
Biomarkers
Assay Development
Preclinical Research
Oncology Research
Protein & Cellular Engineering
Platform Technologies
Experimental Strategy

About

PhD-trained translational biotechnologist with over 15 years of experience advancing complex biological technologies from early discovery through clinical validation and commercialization. My work spans molecular diagnostics, biosensor platforms, cell and gene therapy, and oncology-focused innovation. I specialize in evaluating and translating complex biological systems into practical, scalable solutions, bridging deep science, product development, regulatory considerations, and strategic decision-making. I have led multidisciplinary programs, developed novel experimental platforms, and contributed to technologies adopted in clinical and research settings. My expertise includes scientific due diligence, technology assessment, innovation landscape analysis, experimental strategy, and synthesis of complex data into clear, actionable insights for both technical and non-technical stakeholders. I am particularly interested in emerging diagnostics, advanced therapeutics, precision medicine, and high-impact platform technologies. Author of 22 peer-reviewed publications, including papers in Nature Biotechnology, Nature Methods, and Nature Communications, and recipient of the L’Oréal–UNESCO Women in Science Award.

Education

Rutgers Business School

Mini MBA Biopharma Innovation

Institute of Bioorganic Chemistry (IBCH)

Ph.D. in Molecular Biology with distinction

Lomonosov Moscow State University (MSU)

M.S. in Biochemistry GPA 4.0

Experience

Hologic

Senior Scientist IV - RD Program Lead / 2024Present

Own end-to-end strategic leadership of high-priority diagnostic RD programs defining portfolio roadmap risk strategy and execution plans aligned with business clinical and regulatory objectives. Built and operationalized a prototype manufacturing laboratory supporting delivery of 15000+ point-of-care assay prototypes significantly reducing technology transfer risk and enabling scalable development pipelines. Lead and develop a cross-functional RD team of 5 scientists and research associates setting program priorities driving accountability and ensuring execution of complex multi-stakeholder initiatives. Serve as core RD representative within cross-functional leadership forums influencing product strategy technical direction and gono-go decisions for clinical diagnostic programs. Drove a 5 improvement in assay precision through DoE-driven optimization and scale-up strategy accelerating development timelines and improving product robustness. Coordinate closely with Regulatory Quality Manufacturing and Clinical teams to ensure seamless transition from development to validation and commercialization.

ThermoFisher Scientific

Scientist III - RD Cell and Gene Therapy / 20222024

Provided technical and program leadership for cell and gene therapy platform development defining strategy prioritizing initiatives and ensuring readiness for scale-up and technology transfer. Led a large-scale high-throughput screening campaign of a 600K compound library delivering robust cell-based assay platforms that expanded internal discovery capabilities. Advanced AAV and lentiviral platform performance by improving delivery efficiency expression quality and cost effectiveness to support scalable program growth. Reduced assay turnaround time by 3 through DoE-driven optimization automation and high-content imaging significantly increasing operational efficiency. Directed lentiviral CRISPR screening programs as primary interface with external CRO partners translating complex molecular data into actionable program insights for senior stakeholders.

Sakura Finetek USA

Senior Scientist / 20202022

Established and scaled a molecular biology laboratory in a regulated environment defining infrastructure and workflows to enable scalable in vitro cancer diagnostics development. Led complex RD initiatives in oncology diagnostic development advancing products from concept through manufacturing scale-up and commercialization readiness. Drove development and optimization of IVD reagents consumables and device-integrated workflows providing technical leadership across cross-functional RD efforts. Implemented end-to-end molecular workflows for genomic DNA isolation and characterization from FFPE clinical samples improving data quality and clinical utility. Partnered with external collaborators and clinical teams to support clinical trial evaluation and execute validation programs in compliance with ISO and FDA quality system requirements.

Albert Einstein College of Medicine

Postdoctoral Fellow / 20172019

Engineered novel near-infrared fluorescent biosensor platforms enabling deep-tissue neuronal imaging and spectral multiplexing with optogenetic and fluorescent systems. Established and scaled a high throughput screening framework achieving a 3 reduction in screening time and increasing experimental throughput.

Institute of Bioorganic Chemistry (IBCH)

Research Scientist - Program Lead / 20082017

Promoted to independently lead oncology RD programs owning scientific strategy and execution from concept through technical validation. Led and mentored a multidisciplinary team while providing scientific strategies and project oversight for biologics and biosensor development programs. Achieved an unprecedented 800% improvement in fluorescent biosensor contrast through protein engineering and assay optimization. Expanded high-contrast fluorescent biosensor platforms adopted across IVD and life science research including development of the far-red protein mKate. Secured competitive international research funding including industry-supported grants from Novartis Pharma.

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