Manager, Quality Control
$95,000–$120,000 year
On-site · Bothell, Washington, United States
Job Summary
The Manager, Quality Control – Cell Therapy will lead QC operations supporting GMP manufacturing and release of cell therapy products at Lyell Manufacturing Facility. Responsibilities include overseeing analytical testing, ensuring compliance with cGMP and quality standards, managing laboratory operations, and mentoring QC staff. The ideal candidate should have a strong technical foundation in cell-based assays, experience in a GMP-regulated facility, and a background in managing teams. Expertise in analytical methods and a commitment to quality and regulatory standards are essential.
Required Qualifications
- BSc with a minimum of 10 years’ experience in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
- MSc with a minimum of 7 years’ experience in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
- Minimum of 10 years’ experience in cGMP biopharmaceutical manufacturing with 5+ years of experience in cell therapy
- Solid technical understanding of cell therapy release testing assays is required.
- Minimum of 5 years managing people in technical GMP roles
- 8+ years of experience in a GMP-regulated pharmaceutical, biotech, or related industry
- Prior experience in cell therapy environments is a must
Desired Qualifications
- Experience with electronic systems such as LIMS, ELN, or electronic batch records
- Familiarity with FDA regulatory expectations for advanced therapy medicinal products (ATMPs)
- Experience with method validation and regulatory submissions
- Experience with BMRAM and MasterControl
Additional Requirements
- Candidates must be authorized to work in the U.S. without sponsorship
- Occasional weekend work and holiday coverage will be needed
- This is an onsite role with no remote option
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