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We are seeking an experienced Scientist to join the Lentiviral Vector (LVV) Attributes and Analytics team within Product Analytical Sciences. This role focuses on developing and optimizing flow cytometry-based and cell-based potency assays to support lentiviral vector characterization and engineered cell therapy product development.
The Scientist will collaborate with Process Development, Quality Control, and Regulatory teams to deliver robust, phase-appropriate analytical strategies ensuring process understanding, product comparability, and regulatory success. Expertise in cell-based assays, particularly those related to vector-mediated transduction, immune effector function, and phenotypic characterization using advanced flow cytometry platforms, is required. This position is based in Santa Monica, CA, reporting to a Senior Scientist within Analytical Sciences.
You Will:
- Lead development, optimization, and execution of cell-based potency assays, including flow cytometry assays measuring transduction efficiency, activation, cell killing, cytokine secretion, or other LVV-driven functional responses.
- Design and conduct experiments to assess potency and identity of lentiviral vectors and their functional impact on engineered immune cell products.
- Apply multi-parametric flow cytometry and related tools for product characterization, supporting method development, process monitoring, and comparability studies.
- Collaborate with Process Development and Quality Control to implement scalable analytical methods for LVV and cell product testing.
- Support method qualification, tech transfer, and lifecycle management activities aligned with CMC development timelines.
- Analyze and interpret complex data sets using tools such as FlowJo, GraphPad Prism, and JMP, and communicate findings to cross-functional stakeholders.
- Author and review technical reports, method development protocols, and regulatory documents including IND and BLA sections.
- Stay current with technological and regulatory trends in gene delivery, potency assay development, and vector characterization.
- Provide technical mentorship to junior staff, ensuring scientific rigor and operational excellence in the lab.
- Maintain laboratory instruments, ensuring calibration, maintenance, and troubleshooting are performed.
You Have:
- Three (3) years with BS/BA, or two (2) years with MS/MA in immunology, Cell Biology, Oncology, Molecular Biology, or a related discipline, with experience in biotech, biopharmaceutical, or academic settings.
- Strong expertise in cell-based assays evaluating potency, transduction efficiency, or immune effector function using flow cytometry.
- Hands-on experience with lentiviral vector biology, including vector design, production, or characterization (preferred).
- Proficiency in immune cell culture, including primary T cells or engineered immune cells.
- Familiarity with analytical method development principles, including QbD, and regulatory expectations for potency methods.
- Data analysis and troubleshooting skills; experience with DoE is a plus.
- Ability to clearly communicate scientific findings and development rationale.
The annual base salary ranges from $87,200 to 130,800. Compensation may vary based on factors such as location, experience, and skills. Benefits include a 401(k) plan, paid vacation and holidays, health coverage, and potential participation in incentive programs.