Associate Scientist, Quality Control

Fate Therapeutics•San Diego, CA

23h•Onsite

About The Position

Fate Therapeutics is seeking an Associate Scientist to join its Quality Control team as an individual contributor in the QC laboratory. The role focuses primarily on molecular assay execution, including digital droplet PCR (ddPCR) and DNA/RNA extraction, and includes cross-training in flow cytometry and cell-based potency methods. The position also contributes to laboratory investigations, quality event resolution, continuous improvement, and general laboratory operations. This full-time, exempt role is based at the company’s corporate headquarters in San Diego, California. The position involves testing and quality activities in a regulated laboratory environment, collaboration across functions, and maintaining laboratory readiness and compliance. Work may include handling cells and cell lines of human or animal origin, hazardous materials, and work in controlled or cGMP manufacturing environments that require special gowning.

Requirements

M.S. or B.S. degree in a scientific discipline.
At least 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, with sound judgment.
Highly organized and detail-oriented, with excellent record-keeping abilities and computer proficiency.
Ability to work independently and effectively with others in a fast-paced team environment, prioritize activities across multiple projects, and work with little supervision.

Nice To Haves

Prior experience in a regulated environment such as GMP, GLP, or CLIA is highly preferred.
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.

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 testing and retain samples.
Ensure assigned testing, laboratory activities, and project deliverables are accurate, timely, and compliant 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 on new product introduction, analytical method development and optimization, and method qualification or validation.
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 for QC laboratory processes, analytical performance, data quality, and operational efficiency.
Support validation, qualification, and maintenance of new equipment, partnering with Facilities on equipment lifecycle documentation.
Assist with implementation, optimization, and troubleshooting of analytical methodologies and 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.
Maintain laboratory readiness through upkeep, inventory management, reagent and consumable organization, equipment readiness, and housekeeping in accordance with safety and quality requirements.
Use critical thinking, scientific judgment, and a data-driven approach to troubleshoot assay performance, evaluate unexpected results, and support resolution of laboratory and quality issues.