Analytical Transfer Scientist

The Senior Analytical Transfer Scientist will lead the method transfer, validation, and optimization of analytics for cell and gene therapies. This role involves overseeing transfers to both internal and external quality control labs while ensuring compliance with GMP standards. The successful candidate will conduct advanced testing for characterization, development, stability, and comparability of therapeutic products, and will analyze data for regulatory submissions.

Key Responsibilities

• Lead method transfer, validation, and optimization for cell/gene therapy analytics.
• Oversee transfers to internal/external QC labs and 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.

Requirements & Qualifications

• Master's or PhD in analytical science.
• 6-14 years of experience in cell/gene therapy.
• Proficiency in qPCR, ddPCR, flow cytometry, ELISA, and cell-based potency assays.
• Experience with viral vector assays (AAV, lentivirus).
• Strong knowledge of GMP-compliant method development, validation, and transfer.
• Regulatory filing knowledge for viral vectors and gene-modified cells.
• Data analysis experience with FlowJo, JMP, GraphPad Prism.