Scientist II, Analytical Development, Flow, Function and Bioanalytical Assays

Key Responsibilities

• Focus on assay development and optimization, including but not limited to potency (cell-based), flow cytometry, and bioanalytical (e.g., ELISA) assays.
• Develop and qualify analytical methods to support LVV characterization, including infectious titer assays, vector potency assays, and vector-specific flow cytometry panels.
• Responsible for tech transfer of methods to QC and execution of methods in QC. Perform the assay pre-qualification and qualification activities as needed. Identify and refine critical parameters and material/reagents during assay prequalification activities and generate critical materials including cell banks.
• Ensure the generation of standard operating procedures (SOPs) and laboratory protocols that support product release testing and characterization.
• Collaborate cross-functionally with PD, QC and Manufacturing teams to ensure seamless assay execution, troubleshooting, and continuous improvement.
• Present scientific data and trends at internal and external forums.
• Ensure proper documentation practices including ELN, test method development plan and report, equipment maintenance logs, etc. Contribute to maintenance of laboratory inventories.
• Simultaneously working on multiple projects to meet established timeline while maintaining the highest quality and data integrity standards.

Requirements

• PhD or Master in scientific discipline or equivalent in engineering, and a minimum of 2-5 years related experience; may include post-doctoral experience. Expert knowledge of scientific principles and concepts.
• Expertise in analytical method development and qualification/validation is required.
• Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays, infectious titer assays.
• Experience in developing LVV residual impurities assays.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Solid understanding of ICH guidelines and regulatory expectations for method qualification. Guide the design and execution of method qualification.
• Guide the establishing and authoring of SOPs/procedures for established methods.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Excellent presentation skills and scientific/technical writing skills.
• Excel, Word, PowerPoint, etc.
• GraphPad Prism, other data analysis tools (PowerBI, JUMP, etc).
• CytoExpert, FCS express, NovoExpress, FlowJo, etc.
• ELN, LabVantage, etc.