Principal/Senior Scientist, Clinical Biomarker Laboratory, (LBA)

General Description: We are seeking a highly motivated and skilled Principal or Senior Scientist to join our Clinical Biomarker laboratory. This role will be primarily responsible for the design, development, validation, and execution of ligand-binding assays (LBA), including ELISA, MSD, and other immunoassay platforms, to support biomarker strategies and advance clinical drug development programs. The role will also contribute to flow cytometry-based biomarker assays as needed. The ideal candidate will have a strong scientific background in immunoassay platforms and extensive hands-on experience in developing, validating, and executing fit-for-purpose LBA-based biomarker assays for clinical sample analysis. Experience with flow cytometry assay development and clinical sample testing is desirable but not the primary focus of the role. Essential Functions of the job: · Serve as the lead scientist for the development, optimization, validation, and execution of ligand-binding assays (LBAs) (e.g., ELISA, MSD, Luminex) to support clinical biomarker strategies and clinical development programs. Take end-to-end ownership from assay design and validation through clinical sample testing, data review, and reporting. · Support flow cytometry-based biomarker assays when required to address specific immunology and translational research questions. · Contribute to the establishment and scaling of biomarker assay platforms, including assay standardization, workflow optimization, laboratory readiness, and operational excellence. · Design experimental plans and lead execution of sample analysis to generate high-quality and robust biomarker data. · Support the implementation of new technologies and continuously improve laboratory workflows to enhance efficiency and data quality · Partner cross-functionally with translational science, clinical biomarker, clinical operations and bioinformatics teams, and proactively drive assay alignment with clinical objectives. · Provide subject matter expertise in immune monitoring, pharmacodynamic and safety biomarker analysis; support muti-disciplinary platforms (e.g. molecular assays) if needed. · Author and review technical documentation including method validation and clinical sample analysis protocols, reports, and SOPs. · Ensure quality control, data integrity, and timely delivery of analytical results. · Maintain accurate lab records and mentor junior scientists. · This role is initially an individual contributor. May mentor and help build a growing biomarker laboratory team. Computer Skills: •Proficiency in general software such as Microsoft Office (Word, Excel, PowerPoint), Outlook, Zoom and Teams. Experience with laboratory and data analysis software, including SoftMax Pro, GraphPad Prism, FlowJo, FACS Diva, or equivalent systems, is preferred. Other Qualifications: · Ph.D. in Cell Biology, Molecular Biology, Pharmacy, Immunology, or related field with 3+ years or M.S. with 5+ years of relevant industry experience in a clinical, translational or regulated environment. · Strong hands-on expertise in ligand-binding assay (LBA) development and execution using platforms such as MSD, ELISA, Luminex, or Simoa, including assay optimization, qualification/validation, troubleshooting, and clinical sample analysis. · Hands-on experience with clinical sample testing and fit-for-purpose assay qualification/validation is strongly preferred. · Experience with flow cytometry platforms (e.g., BD FACSCanto, BD FACSymphony, Cytek Aurora) is preferred. Ability to analyze and interpret flow cytometry data is desirable. · Familiarity with relevant regulatory expectations and fit-for-purpose validation approaches for clinical biomarker assays. · Proven track records in supporting clinical biomarker studies with demonstrated domain expertise and familiarity with relevant regulatory guidance for clinical assays to measure target engagement, receptor occupancy, immunophenotyping as well as pharmacodynamics endpoint. · Strong 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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