Associate Scientist, Quality Control

Fate Therapeutics is seeking a motivated Associate Scientist to join the Quality Control (QC) team. As an individual contributor in the QC laboratory, the successful candidate will focus primarily on molecular assay execution, including digital droplet PCR (ddPCR), and DNA/RNA extraction. The Associate Scientist, Quality Control will also cross-train in and perform flow cytometry and cell-based potency methods, building a broad technical skill set across multiple platforms. In addition, this role will contribute to routine laboratory investigations, quality event resolution, continuous improvement initiatives, and general laboratory operations, offering meaningful opportunities to shape how the lab runs. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

• Perform in-process control, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based potency assays.
• Execute processes that support sample receipt and processing for release/stability samples for testing and retains.
• Ensure accurate, timely, and compliant execution of assigned testing, laboratory activities, and project deliverables in accordance with approved procedures and applicable quality requirements.
• Draft, revise, and maintain analytical test methods or equipment SOPs, raw material specifications, and/or sampling plans.
• Collaborate cross-functionally to support new product introduction, analytical method development and optimization, and method qualification or validation activities.
• Participate and lead cross-functional training efforts.
• Support the execution, documentation, and resolution of laboratory investigations, deviations, CAPAs, and other quality events through scientific evaluation, data analysis, and root cause assessment.
• Identify, recommend, and implement continuous improvement opportunities to enhance QC laboratory processes, analytical performance, data quality, and operational efficiency.
• Onboard and support validation, qualification, and maintenance of new equipment, partnering with Facilities to complete and maintain equipment lifecycle documentation.
• Assist with the implementation, optimization, and troubleshooting of analytical methodologies and associated instrumentation, particularly molecular assays and nucleic acid extraction workflows.
• Participate in technical transfer, qualification, and validation protocols for QC assays including protocol execution, data analysis and documentation.
• Onboard new materials and reagents and track qualification of reagents and assay controls.
• Perform technical review of analytical data and associated documentation to ensure accuracy, completeness, traceability, and compliance with applicable procedures and quality standards.
• Maintain laboratory readiness through routine laboratory upkeep, including inventory management, reagent and consumable organization, equipment readiness, and general housekeeping in accordance with applicable safety and quality requirements.
• Apply critical thinking, sound scientific judgment, and a data-driven approach to troubleshoot assay performance, evaluate unexpected results, and support timely resolution of laboratory and quality issues.

 

 

Qualifications

• M.S. or B.S. degree in a scientific discipline with minimum of 5+ years of biotechnology, clinical, or pharmaceutical laboratory experience is required.
• Prior experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
• Hands on experimental skills with qPCR, ddPCR is required, additional competency in flow cytometry, ELISA or cell-based assays is preferred.
• Proficiency with aseptic techniques for working with cell culture, human blood, and blood products is desired.
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.
• Highly organized, detail oriented with excellent record keeping abilities, and computer proficiency.
• Ability to work independently in a high paced team environment, to prioritize activities from multiple projects with little supervision.

Working Conditions & Physical Requirements

• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
• Will require working with cells and cell lines of human and/or animal origin.
• Will require working with hazardous materials.
• May require work in controlled and cGMP Manufacturing environments requiring special gowning.

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $105,000 - $115,000.