Associate Principal Scientist II – LVV Characterization Full-time

Job Title

Major responsibilities

Design, execute, analyze, and interpret in vitro LVV characterization studies.

Develop, optimize, and apply analytical methods to assess key quality attributes of LVV products, including identity, titer, infectivity/transduction activity, purity, integrity, stability, and biological activity.

Develop and optimize one or more of the following analytical assays:

• Physical and functional titer assays
• Infectivity and transduction efficiency assays
• qPCR, dPCR, or RT-qPCR
• Transgene expression assays
• Flow cytometry
• ELISA or other immunoassays
• Western blot, immunofluorescence, or related protein-based assays
• Analysis of viral particles, envelope proteins, and vector-related impurities
• Vector genome structure, integrity, or sequence-related analyses
• Cell-based biological activity assays and other in vitro functional assays

Support the investigation of critical quality attributes (CQAs) and critical process parameters (CPPs) for LVV products, including process development and process optimization activities.

Lead or contribute to analytical method development, optimization, suitability assessment, qualification/validation, technology transfer, and method lifecycle management.

Support LVV stability studies, batch-to-batch comparisons, process comparability assessments, and product consistency evaluations.

Perform statistical analysis and scientific interpretation of experimental data, identify abnormal results, trends, and potential risks, and recommend appropriate follow-up studies.

Prepare study protocols, reports, analytical reports, method documents, and other technical documentation in accordance with internal quality systems and applicable regulatory expectations.

Collaborate cross-functionally with process development, analytical development, quality control, quality assurance, pharmacology/toxicology, and project teams to support timely project delivery.

Manage technical interactions with external CROs, CDMOs, and collaborative laboratories, including study design, experimental follow-up, data review, and result interpretation.

Participate in international meetings, project updates, and technical discussions in English, and prepare technical documents and study summaries in English when required.

Education, Qualifications, Skills and Experience

• Master's degree or above in molecular biology, cell biology, virology, biochemistry, biotechnology, pharmaceutical analysis, or a related discipline.
• Minimum of 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 research and development area.
• Experience in in vitro characterization of LVV/lentiviral vectors is preferred.
• Practical experience with one or more of the following techniques: qPCR, dPCR, RT-qPCR, flow cytometry, ELISA, Western blot, immunofluorescence, cell transduction/infectivity assays, transgene expression analysis, and viral titer assays.
• Sound understanding of the basic structure and production process of LVVs and the ability to relate analytical results to product quality and process conditions.
• Experience in analytical method development, optimization, qualification/validation, technology transfer, or laboratory work in a regulated environment.
• Strong experimental design, data analysis, scientific judgment, and problem-solving skills, with the ability to independently drive research activities.
• Strong technical writing skills, with the ability to accurately document experimental procedures, analytical results, and scientific conclusions.
• Fluent English communication skills, with the ability to work effectively in an English-speaking environment, independently review scientific literature and technical documents, and conduct meetings, project presentations, and technical writing in English.
• Strong communication, collaboration, and project execution skills, with the ability to manage multiple priorities in a fast-paced research and development environment.

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.