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The Assistant Scientist serving as Assistant Director of Vector Manufacturing and Process & Analytical Development supports the strategic expansion of UF’s gene therapy manufacturing capabilities. This position provides advanced scientific expertise and operational leadership in vector production, process optimization, technology transfer, and analytical method development at the Powell Gene Therapy Center. The role ensures high-quality, scalable, and compliant production of viral vectors to support preclinical, IND-enabling, and early-phase clinical programs.
Essential Functions:
1. Vector Manufacturing Leadership
• Oversee and guide AAV vector manufacturing operations.
• Ensure manufacturing activities meet scientific, quality, and safety standards.
• Lead troubleshooting and implement CAPA strategies.
2. Process Development & Technology Transfer
• Design and execute process development studies.
• Implement new manufacturing technologies.
• Coordinate technology transfer across groups.
3. Analytical Method Development
• Lead development and qualification of analytical assays.
• Support QC release and regulatory documentation.
• Ensure analytical comparability and product quality.
4. Documentation, Regulatory & Quality Support
• Prepare SOPs, batch records, and technical reports.
• Support IND and CMC submissions.
• Maintain regulatory-compliant documentation.
5. Team Leadership, Training & Collaboration
• Mentor staff and trainees.
• Coordinate cross-functional communication.
• Represent PGTC in scientific and operational meetings.
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