Cell Therapy QC Lead — GMP Release & Method Lifecycle

Lyell Immunopharma; Bothell (WA); On-site; USD 150,000 - 170,000; Full time

Job summary

Lyell Immunopharma is seeking a highly motivated QC Manager – Cell Therapy to join the LyFE facility in Bothell, WA. The role leads QC operations supporting GMP manufacturing, release of cell therapy products, and transfer of analytical methods to the site, ensuring compliance with cGMP, regulatory guidance, and internal quality systems.

The ideal candidate has 8+ years in GMP environments, strong leadership, and hands-on experience with cell therapy release testing assays (flow cytometry, PCR).

Qualifications

• 8+ years of experience in GMP-regulated pharma/biotech.
• Proven ability to lead a fast-paced GMP team.
• Experience in cell therapy environments is required.
• Strong leadership and team development skills.
• Experience with electronic systems (LIMS/ELN/Electronic batch records).
• Experience with method validation and regulatory submissions.

Responsibilities

• Schedule day-to-day QC laboratory operations supporting release and in-process testing.
• Oversee method lifecycle for analytical assays (flow cytometry, ddPCR, sterility, endotoxin, etc.).
• Perform data review to support COA issuance.
• Manage Contamination Control Program for the site.
• Ensure timely testing and release of raw materials and drug product.
• Support method transfer, qualification, validation, and lifecycle management.
• Mentor and develop QC analysts and supervisors.
• Establish staffing plans and training programs.
• Review and approve analytical records and certificates of analysis.
• Ensure proper maintenance and qualification of laboratory equipment.
• Oversee stability testing programs.
• Collaborate with Manufacturing, QA, Regulatory, and other groups to drive improvements.
• Lead deviations, Change Controls, and CAPAs; MasterControl experience is a plus.
• Prepare and review regulatory filings, and support inspections and audits.

Skills

Leadership

Analytical thinking

Problem solving

GMP experience

Education

Bachelor's or higher in Cell Biology/Immunology

Master's degree in related field

Tools

LIMS

ELN

Electronic batch records

Job description

Lyell Immunopharma is seeking a highly motivated QC Manager – Cell Therapy to join the LyFE facility in Bothell, WA. The role leads QC operations supporting GMP manufacturing, release of cell therapy products, and transfer of analytical methods to the site, ensuring compliance with cGMP, regulatory guidance, and internal quality systems.

The ideal candidate has 8+ years in GMP environments, strong leadership, and hands-on experience with cell therapy release testing assays (flow cytometry, PCR).