Analytical Development Scientist – Flow Cytometry

About the role

AstraZeneca is hiring an Analytical Development Scientist focused on flow cytometry in Shanghai (Guilin Road). The role develops, optimizes, validates and transfers flow cytometry methods for cell therapy products such as CAR-T cell therapy, working closely with R&D, Process Development, QC, QA and Regulatory teams.

Key responsibilities

• Develop, optimize, validate and transfer flow cytometry methods for cell therapy products, including CAR-T and other advanced modalities.
• Develop multiparameter assays for cell identity, purity, viability, transduction efficiency, CAR expression, immune phenotyping, activation, differentiation and exhaustion, and other critical quality attributes.
• Design antibody panels and optimize staining conditions, compensation, controls, gating strategies and assay parameters.
• Perform method validation (specificity, accuracy, precision, linearity, range, detection/quantitation, robustness, stability) and troubleshoot assay variability and instrument issues.
• Analyze data with FlowJo or equivalent software and carry out statistical analysis.
• Maintain 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 related equipment.
• Contribute to platform development, continuous improvement, training and adoption of new flow cytometry technologies.

Required profile

• Master's degree in Immunology, Cell Biology, Biotechnology, Bioengineering, Pharmaceutical Sciences, Medical Laboratory Science or a related field; Master's or above preferred.
• Bachelor's degree with 2+ years of relevant experience, or a Master's with research experience; outstanding fresh graduates may be considered.
• Experience in cell therapy, biopharmaceutical companies, CRO/CDMOs or GMP-regulated environments is preferred.
• Good English reading and writing skills.

Required skills

• Strong knowledge of flow cytometry and multiparameter flow cytometry, including panel design, compensation, controls and gating strategies.
• Proficiency in FlowJo or equivalent software.
• Knowledge of analytical method development, validation, statistical analysis and regulatory requirements such as ICH Q2, GMP and data integrity.
• Technical writing skills for protocols, reports and SOPs.
• Advantageous: cell culture, ELISA, qPCR, cell-based assays, familiarity with cell therapy CQAs, and experience with IND submissions or method lifecycle management.