• Senior Scientist, Biomarker Laboratory, Pathology

    BeOne Medicines (San Carlos, CA)


    General Description:

    We are seeking a highly motivated and detail-oriented Senior Scientist to lead the development, validation, and execution of immunohistopathology (IHC) assays in a clinical biomarker setting. The successful candidate will be instrumental in supporting clinical trials and translational research through the generation of high-quality, tissue-based biomarker data. This role involves close collaboration with pathologists, clinical teams, and CDx development functions to ensure that assays are robust, reliable and fit-for-purpose to support various oncology and non-oncology pipelines.

    Essential Functions of the job:

    + Lead strategic design and implementation of the new IHC workflow.

    + Design, develop and optimize IHC assays for biomarker detection in fresh and FFPE tissue samples.

    + Select and validation antibodies, detection systems, and staining protocols to ensure assay specificity and sensitivity.

    + Validate IHC-based assays and execute clinical sample analysis. Perform and oversee IHC staining and imaging; coordinate with pathologists for interpretation and scoring of results

    + Author and review method development and validation protocols, reports, and SOPs.

    + Ensure quality control, data integrity, and timely delivery of analytical results.

    + Contribute to cross-functional project teams supporting clinical trial biomarker strategies

    + Maintain accurate lab records and mentor junior scientists.

    Supervisory Responsibilities:

    + This role is initially an individual contributor. May supervise lab scientists as the team grows.

    Computer Skills:

    Proficiency in general software such as Microsoft Office (Word, Excel, PowerPoint), Outlook, Zoom, Teams as well as IHC task-related systems.

    Other Qualifications:

    + Ph.D. with 2+ years or M.S. with 4+ years of hands-on IHC assay experience in a clinical, translational or regulated environment

    + Strong background in IHC assay development and validation using fresh or FFPE tissues.

    + Familiarity with automated staining platforms (e.g. Ventana, Leica, Dako) and image analysis software (e.g. HALO, QuPath).

    + Understanding of clinical biomarker strategies and regulatory requirements for exploratory or filling purposes.

    + Demonstrated analytical and problem-solving skills with the ability to think critically.

    + Excellent communication, organization and project management skills.

    + Experience in lab automation, electronic laboratory notebook (ELN), laboratory information management system (LIMS) and initial lab workflow set-up is a plus.

    Education Required:

    PhD in Pathology, Molecular Biology, Immunology, or related field with 2+ years of relevant experience (or MS with 4+ years).

     

    **Travel:** Under 10%

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.