Senior Quality Control Associate

Lyell Immunopharma • Bothell, WA

72d • $45 - $48 • Remote

About The Position

Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. 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. 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.

Requirements

• BS with a minimum of 7 years' experience in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
• MS with a minimum of 4 years' experience 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.

Nice To Haves

• Experience with Master Control is a plus.
• Experience with BMRAM is a plus.

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.

Benefits

• Salary range of $45.43 to $48.08 hourly, with the opportunity to earn an annual bonus.
• Eligible to participate in Lyell's Equity Incentive Plan.
• Subsidized medical, dental and vision plans from the 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.
• 18 days' vacation, 9 days' sick leave, 8 observed holidays, and a floating holiday.
• Summer and winter office shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree