Quality Control Laboratory Manager
2 weeks ago
Senior Manager, Quality Control
(on-site - Seattle, WA)
Join a growing cell therapy organization that focuses on T-cell therapies for autoimmune and degenerative diseases. The organization is continuing to grow and develop in the Seattle area.
Key responsibilities:
- Manage in-process, release, and stability QC data for raw materials and final products
- Establish timelines, proactively review content, and provide quality and compliance expertise
- Support method transfer, method validation, and analytical data integrity
- Manage and establish timelines for deviations, investigations, CAPAs, and change controls
- Maintain relationships with internal and external partners
Background:
- Experienced in the biotech/pharmaceutical industry - ideally cell-therapy
- Experience in management within QC
- Expert in CAPAs, deviations, change controls, investigations, OOS, and OOT
- Experienced in microbiology, qPCR, flow cytometry, ELISA, and cell-based assays
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