Associate Scientist, Quality Control

Fate Therapeutics, Inc.•San Diego, CA

1d•$105,000 - $115,000•Onsite

About The Position

Fate Therapeutics is seeking a motivated Associate Scientist to join its Quality Control (QC) team. This individual-contributor role focuses primarily on executing molecular assays, including digital droplet PCR (ddPCR), and DNA/RNA extraction. The Associate Scientist will also cross-train in and perform flow cytometry and cell-based potency methods, developing technical skills across multiple platforms. The role contributes to routine laboratory investigations, quality event resolution, continuous improvement initiatives, and general laboratory operations. This is a full-time, exempt position at Fate Therapeutics’ corporate headquarters in San Diego, California. The role supports in-process control, lot release, and stability testing, as well as assay implementation, troubleshooting, qualification, validation, and technical transfer. The Associate Scientist also helps maintain laboratory readiness and supports compliance with approved procedures and applicable quality requirements.

Requirements

M.S. or B.S. degree in a scientific discipline.
Minimum of 5+ years of biotechnology, clinical, or pharmaceutical laboratory experience.
Hands-on experimental skills with qPCR and ddPCR.
Strong scientific, analytical, problem-solving, and communication skills, sound judgment, and the ability to work independently and effectively with others.
Highly organized and detail-oriented, with excellent record-keeping abilities and computer proficiency.
Ability to work independently in a fast-paced team environment and prioritize activities across multiple projects with little supervision.

Nice To Haves

Prior experience in a regulated environment such as GMP, GLP, or CLIA.
Additional competency in flow cytometry, ELISA, or cell-based assays.
Proficiency with aseptic techniques for working with cell culture, human blood, and blood products.

Responsibilities

Perform in-process control, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based potency assays.
Execute processes supporting sample receipt and processing for release and stability samples 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 in 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.
Support validation, qualification, and maintenance of new equipment and partner with Facilities to complete and maintain equipment lifecycle documentation.
Assist with 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 upkeep, including inventory management, reagent and consumable organization, equipment readiness, and housekeeping in accordance with 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.