The Role
Perform GMP-compliant QC laboratory testing including cell-based release/stability assays, flow cytometry, and lentiviral vector titer/potency assays. Support method transfer, qualification/validation, LIMS test method authoring, deviations/Change Controls/CAPAs, equipment maintenance, and general QC support on a fixed Wed–Sat schedule in an onsite cell therapy-focused facility.
Summary Generated by Built In
We are seeking a highly motivated and detail-oriented QC Associate II 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 Wednesday through Saturday shift, 10 hours per day, and involves routine laboratory work supporting ongoing preclinical and clinical development programs. This is an onsite role with no remote option.
Key Responsibilities:
- Perform cell-based release and stability assays for cell count, viability and cytotoxicity.
- Execute release lentiviral vector assay to determine titer and potency
- Perform flow cytometry in-process, release and stability testing
- Support and execute method transfer, qualification and validation
- 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 MasterControl is a plus.
- Perform preventative maintenance of QC equipment, and ensure clean and organized, laboratories. Experience with BMRAM is a plus.
- Perform other QC support duties as assigned.
Requirements:
- 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 systems is strongly preferred.
- Detail-oriented with strong organizational and GDP skills.
- Ability to work independently on a fixed schedule (Weds-Sat, 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.
- Work involves repetitive tasks and occasional lifting (up to 25 lbs).
Qualifications:
- Bachelor’s or Master’s degree in biology, Immunology, Cell Biology, or related field.
- 3–5+ 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 (Weds-Sat.).
Additional Information:
- 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 $75,000 to 85,000 per year 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.
Skills Required
- 3-5 years experience in a GMP-regulated pharmaceutical, biotech, or related industry.
- Bachelor's or Master's degree in Biology, Immunology, Cell Biology, or related field.
- Experience with cell-based and flow cytometry-based assays.
- Familiarity with flow cytometry data analysis software (e.g., FCS Express).
- Working knowledge of LIMS systems.
- Ability to work independently on a fixed Wed–Sat, 10-hour/day schedule (onsite).
- Authorized to work in the U.S. without sponsorship.
- Ability to stand for extended periods, wear PPE, and perform repetitive tasks; occasional lifting up to 25 lbs.
- Hands-on experience in a GMP-regulated laboratory environment.
- Experience in cell therapy environments.
- Experience with MasterControl.
- Experience with BMRAM.
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The Company
What We Do
We are entering a new era of medicine, where cancer is treated with cellular therapies: living, smart, targeted drugs. While enormous strides have been made, especially in hematologic cancers, the full promise of these therapies still lies ahead. Cell-based immunotherapies have yet to show substantial benefit in solid tumors, which represent the vast majority of cancers. Our goal is nothing less than to develop curative cell-based therapies for solid tumor cancers.
