Quality Control Laboratory Manager

2 weeks ago


Seattle, United States EPM Scientific Full time

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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