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.