Katya Suslova
Translational Biotechnology Expert | Molecular Diagnostics, Cell/Gene Therapy | Scientific Due Diligence & Innovation Strategy
Research Expertise
About
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 / 2024 — Present
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 / 2022 — 2024
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 / 2020 — 2022
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 / 2017 — 2019
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 / 2008 — 2017
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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