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flow cytometry elisa qpcr ddpcr aav๐ Description
- Lead method transfer, validation, and optimization for cell/gene therapy analytics
- Includes qPCR, ddPCR, flow cytometry, ELISA, and cell-based assays
- Oversee transfers to internal/external QC labs; ensure GMP compliance
- Perform advanced testing for characterization, development, stability, and comparability
- Analyze data and prepare reports for regulatory submissions (IND, BLA, MAA)
- Collaborate with PD, Manufacturing, QC, and R&D across development stages
๐ฏ Requirements
- Master's or PhD in analytical science; 6-14 years in cell/gene therapy
- Experience with qPCR/ddPCR, flow cytometry, ELISA, cell-based potency assays
- Viral vector assays (AAV, lentivirus)
- GMP-compliant method development, validation, and transfer for cell/gene therapy products
- Regulatory filing knowledge for viral vectors and gene-modified cells
- Data analysis with FlowJo, JMP, GraphPad Prism
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