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General Description:

We are seeking a highly motivated and skilled Senior Scientist to join our Clinical Biomarker laboratory. This role will provide scientific and technical leadership in the design, development, validation, and execution of flow cytometry and ligand-binding assays (LBA) to support biomarker strategy and advance clinical drug development programs. The ideal candidate will have a deep scientific understanding of immunoassay platforms and hands-on experience in developing and validating robust fit-for-purpose flow cytometric and LBA-based biomarker assays as well as execute clinical sample analysis.

Essential Functions of the job:

+ Lead the development, optimization and validation of flow cytometry assays (e.g. immunophenotyping, intracellular cytokine staining, receptor occupancy) and ligand binding assays (e.g. ELISA, MSD, ELISA, Luminex) for clinical biomarker analysis.

+ Design experimental plans and lead execution of sample analysis to generate high-quality and robust biomarker data.

+ Collaborate with cross-functional teams including translational science, clinical biomarker scientists, clinical biomarker operations and bioinformatics teams to ensure 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.

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 task-related systems e.g. FlowJo, FACS Diva, Softmax.

Other Qualifications:

+ Ph.D. with 2+ years or M.S. with 4+ years of relevant industry experience in a clinical, translational or regulated environment.

+ Strong hands-on expertise in multi-parameter flow cytometry (e.g. BD FACSCanto, BD FACSymphony, Cyteck Aurora) including panel design, compensation, gating strategies and data analysis (FlowJo, FCS Diva, FCS Express). Experience with cell sorting is a plus.

+ Demonstrated experience in ligand binding assay development using platforms such as MSD, ELISA, Luminex or Simoa.

+ Proven track records in supporting clinical biomarker studies with demonstrated domain expertise and familiarity with relevant regulatory guidances 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.

**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.