Analytical Development Scientist – Flow Cytometry

Major responsibilities

• Develop, optimize, validate, and transfer flow cytometry analytical methods for cell therapy products, including CAR-T cell therapy and other advanced cell therapy modalities.
• Develop and optimize multiparameter flow cytometry assays for cell identity, purity, viability, transduction efficiency, CAR expression, immune phenotyping, activation, differentiation, exhaustion, and other critical quality attributes (CQAs).
• Design antibody panels and optimize staining conditions, compensation, controls, gating strategies, and assay parameters to ensure robust and reliable analytical performance.
• Perform analytical method validation in accordance with applicable regulatory and quality requirements, including specificity, accuracy, precision, linearity, range, detection/quantitation capability, robustness, and stability, as applicable.
• Perform troubleshooting and root-cause analysis for assay variability, unexpected results, and instrument-related issues; implement appropriate corrective and optimization measures.
• Analyze and interpret flow cytometry data using FlowJo or equivalent software, and perform appropriate statistical analysis.
• Prepare and maintain analytical development and validation protocols, reports, SOPs, analytical procedures, method transfer documents, and other technical documentation.
• Support regulatory submissions, technology transfer, process development, QC method implementation, investigations, and audit preparation.
• Operate, maintain, and troubleshoot flow cytometers and associated laboratory equipment in accordance with established procedures.
• Collaborate with R&D, Process Development, QC, QA, and Regulatory teams to support project milestones and resolve analytical or product-related issues.
• Contribute to analytical platform development, continuous improvement, technical training, and the implementation of new flow cytometry technologies.

Education, Qualifications, Skills And Experience

• Master’s degree in Immunology, Cell Biology, Biotechnology, Bioengineering, Pharmaceutical Sciences, Medical Laboratory Science, or a related discipline.
• Master’s degree or above is preferred.
• Candidates with a strong background in flow cytometry and relevant industry or research experience are preferred.
• Strong theoretical and practical knowledge of flow cytometry and multiparameter flow cytometry.
• Proficient in flow cytometry panel design, antibody selection, compensation, controls, gating strategies, and data interpretation.
• Proficient in FlowJo or equivalent flow cytometry data analysis software.
• Good understanding of T-cell biology and relevant immunophenotyping markers.
• Familiarity with cell therapy products and their critical quality attributes is highly desirable.
• Knowledge of analytical method development, validation, and statistical analysis.
• Familiarity with applicable regulatory and quality requirements, including Chinese Pharmacopoeia, ICH Q2, GMP, and data integrity requirements.
• Experience with cell culture, ELISA, qPCR, cell-based assays, or other analytical techniques is an advantage.
• Strong technical writing skills, with the ability to independently prepare protocols, reports, SOPs, and technical transfer documents.
• Good English reading and writing skills, with the ability to understand scientific literature and prepare technical documentation.
• Bachelor’s degree with 2+ years of relevant experience in flow cytometry, analytical development, cell therapy, biopharmaceutical R&D, or a related field.
• Master’s degree or above with relevant research experience; outstanding fresh graduates may be considered.
• Experience in cell therapy, biopharmaceutical companies, CRO/CDMOs, or GMP-regulated environments is preferred.
• Experience in flow cytometry analytical method development, validation, or technology transfer is highly preferred.
• Experience supporting IND submissions, regulatory inspections, analytical investigations, or method lifecycle management is a plus.