Quality Control Manager

Lyell Immunopharma • Bothell, WA

6d • $150,000 - $170,000 • Onsite

About The Position

Lyell is seeking a highly motivated QC Manager – Cell Therapy to lead Quality Control operations at the Lyell Manufacturing Facility (LyFE) in Bothell, Washington. The role supports GMP manufacturing, cell therapy product release, and transfer of analytical methods to the site. The QC Manager oversees analytical testing and data review, environmental monitoring, laboratory compliance, data integrity, and method lifecycle management to ensure products meet regulatory, safety, and quality standards. The role ensures adherence to cGMP, regulatory guidance, and internal quality systems while supporting clinical and commercial manufacturing.

The position requires experience in a GMP-regulated facility and a technical foundation in one or more cell therapy release-testing assay areas, such as cell-based potency, flow cytometry, or PCR-based assays. It is onsite with no remote-work option. Occasional weekend and holiday work is required, and the shift structure may be continually assessed and modified to support product delivery. Candidates must be authorized to work in the United States without sponsorship.

The listed annual salary range is $150,000 to $170,000, with the opportunity to earn an annual bonus. Employees are also eligible to participate in Lyell’s Equity Incentive Plan. Lyell describes its culture as grounded in Science, Respect, Collaboration, and Courage, and is committed to an open, diverse, and inclusive workplace.

Requirements

• At least 8 years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
• Prior experience in cell therapy environments.
• At least 10 years of experience in cGMP biopharmaceutical manufacturing, including at least 5 years in cell therapy.
• At least 5 years of experience managing people in technical GMP roles.
• A solid technical understanding of cell therapy release-testing assays.
• A technical foundation in one or more release assay areas, such as cell-based potency, flow cytometry-based, or PCR-based assays.
• Proven ability to manage competing priorities and lead a team in a fast-paced, time-critical GMP environment.
• Strong leadership and team development skills.
• Excellent analytical and problem-solving abilities.
• Experience with electronic systems such as LIMS, ELN, or electronic batch records.
• Experience with method validation and regulatory submissions.
• Familiarity with FDA regulatory expectations for advanced therapy medicinal products (ATMPs).
• BSc with at least 10 years of relevant experience, such as in Cell Biology, Immunology, or Flow Cytometry; or MSc with at least 7 years of relevant experience in those fields.
• Authorization to work in the United States without sponsorship.
• Willingness to work occasional weekends and holidays.

Nice To Haves

• Experience with BMRAM.
• Experience with MasterControl.

Responsibilities

• Schedule day-to-day QC laboratory operations supporting release and in-process testing of cell therapy products.
• Oversee the lifecycle of analytical assays, including flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
• Review data to support issuance of drug product Certificates of Analysis.
• Manage the manufacturing site’s Contamination Control Program.
• 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.
• Author and review regulatory filings, and support licensing inspections and client audits.

Benefits

• Opportunity to earn an annual bonus.
• Eligibility to participate in Lyell’s Equity Incentive Plan.
• Lyell offers employees a range of compensation and benefits, though specific additional benefits are not listed.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager