Senior Scientist, Biomarker Laboratory, Pathology

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 validate antibodies, detection systems, and staining protocols to ensure assay specificity and sensitivity. Validate IHC-based assays and execute clinical sample analysis in compliance with applicable regulatory requirements (e.g., FDA, EMA, NMPA) and fit-for-purpose validation principles. 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, ensuring alignment with regulatory expectations for clinical biomarker assays. Ensure quality control, data integrity, and timely delivery of analytical results in accordance with GxP and regulatory standards. Support biomarker activities for global clinical trials and contribute to cross-functional project teams, ensuring that assay development and data generation meet global regulatory and submission requirements. Act as a China-site counterpart to the US biomarker laboratory, ensuring alignment in workflows, assay performance, and compliance standards across regions. Maintain accurate and audit-ready 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 3+ years or M.S. with 5+ years of hands-on IHC assay experience in a clinical, translational or regulated environment. Fluent in both spoken and written English is required, with the ability to work effectively in an English-speaking environment on a daily basis, actively participate in and contribute to global meetings and cross-regional discussions, communicate complex scientific concepts clearly to international stakeholders, and independently prepare and review scientific, technical, and regulatory documents in English. 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. 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