Senior Quality Control Associate

Role Summary

Senior Quality Control Associate at the Lyell Manufacturing Facility, LyFE in Bothell, WA. The role requires hands-on experience in a GMP-regulated facility and proficiency in cell-based and flow cytometry–based assays, with cell therapy experience desirable. This onsite position supports ongoing clinical development programs and follows a Sunday–Wednesday, 10-hour-per-day schedule.

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/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 (MasterControl experience 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 laboratories are clean and organized.
• QC support duties as assigned, including experience with BMRAM where applicable.

Qualifications

• 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.
• 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.).
• Shift work, weekend work and holiday coverage.

Skills

• Cell-based assays; Flow cytometry; Data analysis; GMP compliance; LIMS familiarity; FCS Express or similar software; Cross-functional collaboration; Attention to detail; Independent work capacity.

Education

• BS in Cell Biology, Immunology, or Flow Cytometry
• MS in Cell Biology, Immunology, or Flow Cytometry

Additional Requirements

• Overtime may be required occasionally.
• Physical demands: ability to stand for extended periods; ability to lift up to 25 lbs; PPE required in the laboratory.