Manager, Quality Control

We are seeking a highly motivated Manager, Quality Control – Cell Therapy to join our dynamic and high-performing team at the Lyell Manufacturing Facility, LyFE in Bothell, WA. The role will be responsible for leading Quality Control operations supporting GMP manufacturing, release of cell therapy products and the transfer of analytical methods to the site.

Requirements

• Schedule day-to-day QC laboratory operations supporting release and in-process testing of cell therapy products.
• Oversee analytical assays such as flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
• Manage the Contamination Control Program for the manufacturing site
• Ensure timely testing and release of raw materials and drug product.
• Support method transfer, qualification, validation, and lifecycle management of analytical methods.
• Manage, mentor, and develop QC analysts and supervisors.
• Establish staffing plans and training programs to support laboratory operations.
• Review and approve analytical records, certificates of analysis, and laboratory documentation.
• Ensure proper maintenance and qualification of laboratory equipment.
• Oversee stability testing programs
• Partner with Manufacturing, QA, Regulatory, Process and Analytical Development, Manufacturing Sciences and Technology and Supply Chain to support product release and continuous improvement.
• Initiate, lead and participate in deviations, Change Controls and CAPAs.

Benefits

• Subsidized medical, dental and vision plans
• FSA
• Company provided Life and AD&D Insurance
• STD and LTD Insurance
• ESPP
• 401(k) Plan with Company match
• Mass transit commuter benefits
• Cell phone reimbursement
• Paid time off benefits
• Sick leave
• Observed holidays
• Floating holiday