Senior Quality Control Associate

Role Summary

Senior Quality Control Associate at Lyell Manufacturing Facility, LyFE in Bothell, WA. Conducts cell-based and flow cytometry-based assays in a GMP-regulated facility to support ongoing clinical development programs. On-site role with Sunday through Wednesday, 10 hours per day.

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.

Qualifications

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

Skills

• Cell biology
• Immunology
• Flow cytometry
• GMP compliance
• LIMS
• Data analysis and review
• Method transfer and validation

Education

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

Additional Requirements

• On-site role with no remote work option
• Ability to stand for extended periods and work in PPE
• Occasional lifting up to 25 lbs
• Occasional overtime and weekend/holiday coverage