Associate Principal Scientist II – LVV Characterization

About the role

AstraZeneca is hiring an Associate Principal Scientist II for LVV (lentiviral vector) characterization in Shanghai. The role covers designing and running in vitro characterization studies, developing and validating analytical methods, supporting critical quality attribute investigations and working closely with process development, quality and project teams.

Key responsibilities

• Design, execute, analyze and interpret in vitro LVV characterization studies.
• Develop, optimize and apply analytical methods for identity, titer, infectivity/transduction activity, purity, integrity, stability and biological activity.
• Develop and optimize assays such as physical and functional titer, infectivity and transduction efficiency, qPCR/dPCR/RT-qPCR, transgene expression, flow cytometry, ELISA, Western blot and immunofluorescence, and analyses of viral particles, envelope proteins and vector impurities.
• Support investigation of critical quality attributes (CQAs) and critical process parameters (CPPs), including process development and optimization.
• Lead or contribute to method development, qualification/validation, technology transfer and method lifecycle management.
• Support stability studies, batch-to-batch comparisons, process comparability and product consistency evaluations.
• Perform statistical analysis of data, identify trends and risks, and recommend follow-up studies.
• Prepare protocols, reports, method documents and other technical documentation in line with quality systems and regulatory expectations.
• Collaborate across process development, analytical development, quality control, quality assurance, pharmacology/toxicology and project teams, and manage interactions with external CROs, CDMOs and laboratories.
• Participate in international meetings and prepare technical documents and study summaries in English.

Required profile

• Master's degree or above in molecular biology, cell biology, virology, biochemistry, biotechnology, pharmaceutical analysis or a related discipline.
• At least 5 years of relevant post-master's experience, or 3 years of relevant postdoctoral experience.
• Experience in viral vectors, gene therapy, cell and gene therapy products, biologics analysis or a related R&D area.
• Experience in in vitro characterization of LVV/lentiviral vectors is preferred.
• Sound understanding of the structure and production process of LVVs and the ability to link analytical results to product quality and process conditions.
• Fluent English, able to work in an English-speaking environment and write technical documents.

Required skills

• Practical experience with qPCR, dPCR, RT-qPCR, flow cytometry, ELISA, Western blot, immunofluorescence, cell transduction/infectivity assays, transgene expression analysis and viral titer assays.
• Experience in analytical method development, optimization, qualification/validation, technology transfer or regulated laboratory work.
• Strong experimental design, data analysis, technical writing and communication skills.