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

• Masters degree in Immunology Cell Biology Biotechnology Bioengineering Pharmaceutical Sciences Medical Laboratory Science or a related discipline.
• Masters 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.
• Bachelors degree with 2 years of relevant experience in flow cytometry analytical development cell therapy biopharmaceutical R&D or a related field.
• Masters 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.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.