A

AstraZeneca

Global pharmaceutical company developing prescription medicines

Analytical Development Scientist - Flow Cytometry

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeShanghai, ChinaNo salary listedIn-person

About the Job

Requirements

  • A Master's degree in Immunology, Cell Biology, Biotechnology, Bioengineering, Pharmaceutical Sciences, Medical Laboratory Science, or a related discipline is required.
  • Candidates may qualify with a bachelor's degree and 2 or more years of relevant experience in flow cytometry, analytical development, cell therapy, biopharmaceutical research and development, or a related field.
  • Candidates with a Master's degree or above and relevant research experience may be considered; outstanding recent graduates may also be considered.
  • Strong theoretical and practical knowledge of flow cytometry and multiparameter flow cytometry is required.
  • Proficiency in flow cytometry panel design, antibody selection, compensation, controls, gating strategies, and data interpretation is required.
  • Proficiency in FlowJo or equivalent flow cytometry data analysis software is required.
  • A good understanding of T-cell biology and relevant immunophenotyping markers is required.
  • Knowledge of analytical method development, validation, and statistical analysis is required.
  • Strong technical writing skills and the ability to independently prepare protocols, reports, standard operating procedures, and technical transfer documents are required.
  • Good English reading and writing skills, including the ability to understand scientific literature and prepare technical documentation, are required.

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.
  • 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 and quantitation capability, robustness, and stability, as applicable.
  • Troubleshoot and perform root-cause analysis for assay variability, unexpected results, and instrument-related issues, and 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, standard operating procedures, analytical procedures, method transfer documents, and other technical documentation.
  • Support regulatory submissions, technology transfer, process development, quality control method implementation, investigations, and audit preparation.
  • Operate, maintain, and troubleshoot flow cytometers and associated laboratory equipment in accordance with established procedures.
  • Collaborate with research and development, Process Development, Quality Control, Quality Assurance, and Regulatory teams to support project milestones and resolve analytical or product-related issues.
  • Contribute to analytical platform development, continuous improvement, technical training, and implementation of new flow cytometry technologies.

Desired Qualifications

  • A strong background in flow cytometry and relevant industry or research experience is preferred.
  • Familiarity with cell therapy products and their critical quality attributes is highly desirable.
  • Familiarity with applicable regulatory and quality requirements, including Chinese Pharmacopoeia, ICH Q2, Good Manufacturing Practice, and data integrity requirements, is preferred.
  • Experience with cell culture, enzyme-linked immunosorbent assay, quantitative polymerase chain reaction, cell-based assays, or other analytical techniques is an advantage.
  • Experience in cell therapy, biopharmaceutical companies, contract research or development and manufacturing organizations, or Good Manufacturing Practice-regulated environments is preferred.
  • Experience in flow cytometry analytical method development, validation, or technology transfer is highly preferred.
  • Experience supporting Investigational New Drug submissions, regulatory inspections, analytical investigations, or method lifecycle management is a plus.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

Recently Posted Jobs

Explore more opportunities at AstraZeneca

See more jobs