Scientist, Clinical Biomarker Laboratory, Flow Cytometry

Role Summary

Scientist to join the Clinical Flow Cytometry group as Cytometer Instrument Lead, performing clinical testing, assay/panel development, and validation under GCLP guidelines to deliver biomarker data supporting clinical programs across multiple therapeutic areas.

Responsibilities

• Serve as an internal technical expert (Instrument Lead) for flow cytometry instrumentation, operation, and maintenance.
• Ensure cytometers are harmonized to generate equivalent data, ready for clinical acquisition, with a stringent QC program and documentation meeting GCLP compliance for audits.
• Identify and troubleshoot instrumentation, assay, or workflow issues; implement mitigation strategies to minimize downtime or data loss.
• Responsible for data management and database backups adhering to GCLP and regulatory needs.
• Collaborate with Global Instrument Leads on maintenance, harmonization, and documentation practices.
• Train and mentor junior staff in flow cytometry methods, instrumentation, and assay execution.
• Execute clinical sample testing under GCLP, including PBMC and whole blood processing, staining, and high-parameter immunophenotyping.
• Adhere to established workflows and documentation procedures while seeking improvements for accuracy and efficiency.
• Design, develop, and optimize multiparameter flow cytometry panels and assays, including ex vivo functional profiling (e.g., intracellular cytokine staining, proliferation, cell activation).
• Lead or support assay fit-for-purpose qualification and validation to ensure clinical compliance.
• Perform data acquisition, gating analysis, interpretation, and reporting of study data.
• Contribute to analytical study documentation including SOPs, study plans, and study reports as needed.
• Stay current with emerging technologies, reagents, and industry best practices in clinical cytometry.
• Occasional overtime or weekend shifts as needed.

Qualifications

• Ph.D., MS, or BS in Immunology, Life Sciences, Biology, or related field; 5+ years of translational/clinical biomarker flow cytometry experience.
• Strong expertise with flow cytometry instrumentation (Cytek Aurora, BD Symphony/Fortessa, or equivalent) including setup, troubleshooting, and maintenance.
• Proven experience in clinical laboratory environments with adherence to GCLP or other regulated standards.
• Demonstrated success in designing, developing, and validating multiparameter flow cytometry assays for clinical applications.
• Hands-on experience in immunology-based functional assays (intracellular cytokine staining, T cell immunophenotyping, receptor occupancy assays).
• High proficiency with flow cytometry analysis software (FCS Express, FlowJo, OMIQ) and data interpretation.
• Strong organizational, computational, and documentation skills (Excel, GraphPad Prism, PowerPoint, Word).
• Excellent written, presentation, and interpersonal communication skills; ability to collaborate across teams and with external partners.
• Track record of flexibility and problem-solving in a fast-paced environment.

Skills

• Flow cytometry instrumentation and assay development
• Data management and regulatory compliance (GCLP)
• Multiparameter panel design and immunophenotyping
• FCS Express, FlowJo, OMIQ analysis
• Documentation, SOPs, study plans, and reporting

Education

• Ph.D., MS, or BS in Immunology, Life Sciences, Biology, or related field