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 and detail-oriented Senior Quality Control Associate to join our dynamic team at the Lyell Manufacturing Facility, LyFE in Bothell, WA. The ideal candidate will have hands-on experience in a GMP-regulated facility and be proficient in conducting cell-based and flow cytometry-based assays. Experience in cell therapy is highly desirable. This role requires working a Sunday through Wednesday shift, 10 hours per day, and involves routine laboratory work supporting ongoing clinical development programs. This is an onsite role with no remote work option.
KEY RESPONSIBILITIES:
• Perform cell-based functional assays to assess potency, viability and cytotoxicity for release and stability testing.
• Execute flow cytometry in-process, release and stability testing.
• Perform data analysis and data review and approval for release and stability testing.
• Support and execute method transfer, qualification and validation activities.
• Participate in authoring test methods and developing and validating blueprints for testing in LIMS.
• Maintain compliance with GMP regulations and internal SOPs and methods during all QC operations.
• Initiate, lead and participate in deviations, Change Controls and CAPAs. Experience with Master Control is a plus.
• Collaborate closely with cross-functional teams including QA, Process and Analytical Development, MSAT and Supply Chain.
• Perform preventative maintenance of QC equipment and ensure the laboratories are consistently clean and organized.Experience with BMRAM is a plus. Perform QC support duties as assigned.
EDUCATION & REQUIREMENTS:
- BS with a minimum of 7 years’ exp. in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
- MS with a minimum of 4 years’ exp. in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
- 5+ years of experience working in a GMP-regulated laboratory environment.
- Experience with cell and flow cytometry-based assays is required.
- Familiarity with software tools for flow cytometry data analysis (e.g. FCS Express).
- Strong attention to detail, organizational skills, and ability to work independently on a fixed schedule (Sunday–Wednesday).
- 3-5 years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
- Prior experience in cell therapy environments is a plus.
- Working knowledge of LIMS is strongly preferred.
- Detail-oriented with strong organizational and GDP skills.
- Ability to work independently on a fixed schedule (Sunday -Wednesday, 10 hours/day).
- Overtime may be required occasionally, based on business needs.
- Ability to stand for extended periods and work in a laboratory environment wearing personal protective equipment required.
- 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 $45.43 to $48.08 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.
