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.
POSITION SUMMARY:
We are seeking a Quality Control Associate I to join our Quality Control team at Lyell’s Manufacturing Facility in Bothell WA. This role supports sample management and routine environmental monitoring activities in a cGMP-compliant facility. The ideal candidate will bring hands-on experience in a GMP environment and familiarity with working in a cell therapy facility. This position plays a critical role in supporting quality systems, ensuring data integrity, and maintaining compliance with regulatory requirements. Experience with LIMS systems such as LabVantage and/or MODA is preferred. This is an onsite role with no remote work option.
KEY RESPONSIBILITIES:
- Perform routine environmental monitoring of cleanrooms including viable and non-viable particulate monitoring.
- Read and record results for EM samples and ATQ and APS samples
- Perform media growth promotion and absence of growth testing
- Perform gowning qualification sampling
- Perform microbiological-based QC release testing including Sterility, Endotoxin and Mycoplasma
- Conduct sample management tasks including receipt, storage, and distribution of samples to QC.
- Manage Stability Protocol testing schedule for QC
- Point of contact to coordinate and perform shipment of samples to other sites or contract labs.
- Maintain compliance with GMP regulations and internal SOPs and methods during all QC operations.
- Participate in data review and ensure proper GDP documentation practices are followed (ALCOA+ principles).
- Support EM excursion investigations, deviations, and CAPAs related to QC sample handling and environmental monitoring.
- Perform equipment preventative maintenance within the QC lab.
- Collaborate effectively with cross-functional teams including Manufacturing, QA, Warehouse and Facilities.
- Perform other QC support duties as assigned.
EDUCATION & REQUIREMENTS:
- Bachelor's degree in Biology, Chemistry, Microbiology, or a related life sciences field preferred. Equivalent experience may be considered.
- 1–3 years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
- Prior experience in immunotherapy or cell therapy environments is a plus.
- Hands-on experience with sample management and/or environmental monitoring.
- Working knowledge of LIMS systems, especially LabVantage and MODA, is strongly preferred.
- Detail-oriented with strong organizational and documentation skills.
- Ability to work independently on a fixed schedule (Wed–Sat, 10 hours/day).
- Overtime may be required occasionally, based on business needs.
- Ability to stand for extended periods and work in cleanroom environments.
- Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non sterile and sterile gowns.
- Must be able to wear personal protective equipment (PPE) for extended periods.
- Work involves repetitive tasks and occasional lifting (up to 25 lbs.).
- Shift work, weekend work and holiday coverage
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.
The salary range for this position is $31.25 - $36.06 hourly, 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.
Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown.
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.
