Senior Analytical Transfer Scientist

Added
less than a minute ago
Type
Full time
Salary
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Related skills

flow cytometry elisa qpcr ddpcr aav

๐Ÿ“‹ 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

๐ŸŽฏ 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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