Quality Control Manager – Cell Therapy

 

Position Summary:

We are seeking a highly motivated QC Manager – Cell Therapy to join our dynamic and high-performing team at the Lyell Manufacturing Facility (LyFE) in Bothell, WA. The QC Manager 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. This role 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 QC Manager ensures adherence to cGMP, regulatory guidance, and internal quality systems while supporting clinical and commercial manufacturing.

The ideal candidate will have experience in a GMP-regulated facility with a good technical foundation in one or more of the following assays required for release testing of cell therapy products: cell-based potency, flow cytometry-based, or PCR-based. This is an onsite role with no remote work option.

Key Responsibilities:

• Schedule day-to-day QC laboratory operations supporting release and in-process testing of cell therapy products.
• Oversee method lifecycle for analytical assays such as flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
• Perform data review to support drug product Certificate of Analysis issuance.
• 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. Experience with BMRAM is a plus.
• 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. Experience with MasterControl is a plus.
• Author and review regulatory filings, and support licensing inspections and client audits.

Requirements:

• 8+ years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
• Proven ability to manage competing priorities and lead a team in a fast-paced, time-critical GMP environment.
• Prior experience in cell therapy environments is a must.
• 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).
• Occasional weekend work and holiday coverage will be needed.

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.

Additional Information:

• Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as quickly as possible, weekend and holiday work will occasionally be required. We are looking for passionate team members who are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.
• This is an onsite role with no remote option.
• Candidates must be authorized to work in the U.S. without sponsorship.

 

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.