Scientist, LVV Characterization AD

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.