Quality Control Associate II

Lyell Immunopharma•Bothell, WA

2h•$75,000 - $85,000•Onsite

About The Position

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.

Requirements

3-5 years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
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).

Nice To Haves

Prior experience in cell therapy environments is a plus.
Experience with MasterControl is a plus.
Experience with BMRAM is a plus.

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.