AstraZeneca
From AstraZeneca's careers page
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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.
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.
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.
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