Thomas P. McNicholas

Director - Advanced Staining Innovation at Leica Biosystems

Greater Philadelphia

About

Ph.D. chemist with a proven record of innovating novel products and solutions. Experienced in setting strategy and building highly effective teams in a matrixed organization to deploy strategic goals. Professional expertise in developing IVD and other medical devices (RUO, Class I,II, III and IVDR Class A, B & C) through a stage-gate development process. My responsibilities include setting business strategy, developing business cases, owning project budgets, revenue projections, visual product management timelines, customer persona definition, leading customer interactions, defining minimum marketable product requirements, risk management, marketing strategies, health economics strategies as well as regulatory engagement and clinical evidence plan development. I have ~28 peer reviewed publications (with over 4200 author citations) and 4 filed patents (one licensed). I thrive both as a business and technology leader as well as a collaborator.

Experience

  • Leica Biosystems (Full-time · 6 yrs 4 mos)
    • Director - Advanced Staining Innovation
      Apr 2026 - Present · 3 mos

      • Project Leader for Pharma Partner programs focused on developing AI based quantitative, continuous scoring assays for TROP2. • Developing AI and computational pathology strategy to support precision medicine within CDx covering ADC pipelines. • Manage and expand third-party AI partnerships.

    • Sr. Innovation Manager - Spatial Biology
      Apr 2025 - Apr 2026 · 1 yr 1 mo

      • Project Leader for pharma partner assay development involving AI/ML and multiplex IHC/IF • Digital and computational pathology SME • Cultivation and expansion of strategic pharma and AI partnerships • Technical subject matter expert in end-to-end assay development including spatial biology, multiplexing, multiomics, digital pathology and computational pathology including AI/ML.

    • Sr. Product Technology Manager - Spatial Biology
      Jun 2024 - Apr 2025 · 11 mos

      • Performed market analysis to direct strategic focus based on TAM, SAM, SOM and competitive breakdown. • Built growth-bridge to achieve 7% market share expansion over 10 years.

  • Thermo Fisher Scientific (Chelmsford, MA)
    • Staff Scientist
      2018 - 2020 · 2 yrs

      • Won Thermo Fisher Intensifying Innovation Grant (one of eight selected companywide) to study graphene and graphene-based coatings for next generation purification applications. • Managed projects with 2-10 diverse, global team members ensuring successful product launches. • Won Thermo Fisher Collaborative Research Contracts Grant (one of eleven selected companywide) toward development of a high-throughput multiplexed sensor for heavy metal detection and bioproduction support.

    • Senior Scientist
      2017 - 2018 · 1 yr

      Making the world cleaner, healthier and safer. • Identified and evaluated > 12 technologies from startups and OEM for value addition to product portfolio. • Algorithm development and chemistry liaison with software engineers for successful product launch. (> $1M) • Direct interaction with marketing and sales to guide technology development and product roadmaps. • Internal consultant to projects spanning cross-functional business units, including bio-production, bio-sensing and protein analysis.

  • Senior Scientist at Daktari Diagnostics
    2016 - 2017 · 1 yr

    Nanotechnology enabled point of care IVDs for troponin cardiac distress markers, HIV and HCV. Anywhere. Care. • Developed new antibody-nanoparticle bioconjugation and reagent chemistries for IVDs focusing on troponin. • Led protein & nanoparticle characterization and assay improvement projects. • Supervised teams of 3-5 research associates and technicians.

  • Senior Research Associate at AgaMatrix
    2013 - 2016 · 3 yrs

    Next generation electrochemical biosensors for blood glucose monitoring. • Led reagent formulation and algorithm development work resulting in ISO compliance of next generation IVD devices. • Developed assays which evaluate enzyme activity and stability which improved the accuracy of product support work as well as improved efficiency by 2 orders of magnitude. • Directed manufacturing/production support of prototype device scale-up (250,000+). • Developed code for increasing efficiency of data processing and database management. • Lead researcher in clinical investigations with direct customer interaction.

  • Technical Consultant at Nano-C, Inc.
    2012 - 2013 · 1 yr

    Leading innovator in the chemistry of nanostructured carbon. • Collaborated closely with industrial partners during technology development. • Successfully led technology transfer of patented carbon separation technology that I developed at MIT.