Manager, Quality Control

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response.  We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. 

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. This role oversees analytical testing, 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  cell-based potency, flow cytometry-based or PCR-based assays required for release testing of cell therapy products. This is an onsite role with no remote work option.

KEY ROLE AND RESPONSIBILITIES:

• 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. 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.


• Support regulatory filings, inspections and client audits.

PREFERRED EXPERIENCE/EDUCATION:

• 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

KNOWLEDGE, SKILLS AND ABILITIES:

• 8+ years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.


• 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


• Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible weekend work, and holiday work will occasionally be required. We are looking for passionate team members to join our team that 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.

The salary range for this position is $124,000 - 150,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan