Senior Flow Cytometry QC Analyst (Cell Therapy)

NCSL International; Seattle (WA); On-site; USD 93,000 - 165,000; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a senior Quality Control Analyst to serve as SME for flow cytometry based cell characterization, potency and release assays in a GMP laboratory. The role leads assay development, validation, and transfer, and collaborates across CMC, Manufacturing, Clinical and Regulatory teams.

Ideal candidates have 5+ years in biologics/cellular therapeutics, hands-on flow cytometry, and expertise with BD FACSCanto/LSR, MACSQuant, FlowJo, and a strong GMP

Qualifications

• BS/MS in a biological science or equivalent experience.
• 5+ years with biologics and/or cellular therapeutics.
• Hands-on experience in flow cytometry to characterize cells.
• Experience with analyzers such as Miltenyi MACSQuant, BD FACSCanto/LSR, Guava easyCyte.
• Familiarity with FlowJo, JMP and similar software.
• Strong communication and writing skills.

Responsibilities

• Lead technical support and troubleshooting for flow cytometry-based assays.
• Own development, optimization and transfer of analytical methods.
• Lead assay design, execution, documentation and validation.
• Lead multi-color flow cytometry panel design and optimization.
• Serve as primary QC SME in cross-functional teams (CMC, Manufacturing, Regulatory).
• Mentor junior team members in flow cytometry and GMP practices.
• Perform and oversee cGMP testing of materials and products.
• Write SOPs and test methods.
• Conduct deviation and CAPA investigations and root cause analysis.
• Maintain cell lines and reference materials; qualify and calibrate equipment.

Skills

Flow cytometry

Communication skills

Data analysis

GMP practices

Mentoring / training

Education

BS in Biological sciences

MS in Biological sciences

Tools

Miltenyi MACSQuant

BD FACSCanto/LSR

Guava easyCyte

FlowJo/JMP

Job description

Fred Hutchinson Cancer Center in Seattle is seeking a senior Quality Control Analyst to serve as SME for flow cytometry based cell characterization, potency and release assays in a GMP laboratory. The role leads assay development, validation, and transfer, and collaborates across CMC, Manufacturing, Clinical and Regulatory teams.

Ideal candidates have 5+ years in biologics/cellular therapeutics, hands-on flow cytometry, and expertise with BD FACSCanto/LSR, MACSQuant, FlowJo, and a strong GMP