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Senior Manager, Quality Analytical Microbiology Cell And Gene (Hybrid)
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Full-time
- Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
- Assists in preparation of audit responses, BLA, MAA, IND/IMPD submissions
- In-depth knowledge of Microbiology assays including assay validation / verification, and contamination control strategy
- Strong experience in cell and gene therapy/Biologics
- Strong CMC/Regulatory experience
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