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Senior Director of Quality Control
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- The Alachua manufacturing site is part of Ascend Advanced Therapeutics, a gene therapy CDMO. Ascend is a specialist AAV development partner working to support the next-generation of life-science innovators in bringing gene therapy products to patients.
- Ensures compliance with GLP and cGMP guidelines both internally at Ascend and at Contract testing labs.
- In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV analytical testing and documentation for submission to regulatory agencies.
- Function as an internal expert in molecular Biology test methods used for release and characterization of Gene Therapy products intended for human use.
- Actively support the preparation of CMC regulatory filings including methods, batch analysis, and stability sections.
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