Lyellimmunopharma
Quality Control Associate II
Salary
Job description
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 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.
