Quality Control Analyst III/IV

About the role

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. The Quality Control laboratory performs in-process and release testing in support of Human Cell and Gene Therapy Phase I/II clinical research studies. We are looking for a dynamic, skilled, and detail-oriented senior candidate to join our team.

Responsibilities

• Lead technical support, root-cause analysis, and troubleshooting for flow cytometry-based characterization, identity, purity, viability, and potency assays used for in-process and product release testing.
• Own development, optimization, and transfer of analytical methods from internal/external partners in alignment with ICH / FDA requirements.
• Lead the design, execution, documentation and validation of analytical assays.
• Lead the design and optimization of multi-color flow cytometry panels.
• Serve as the primary flow cytometry QC representative in cross-functional teams and SME for CMC, Manufacturing, Clinical, and Regulatory.
• Acts as a senior functional mentor to more junior team members in flow-cytometry technique, data analysis, and GMP practices and may serve as a technical point of contact within the work group/project team.
• Perform and oversee in-process, lot release, and stability cGMP testing of raw materials, intermediates, and human cell and gene therapy products.
• Perform data review and trend analysis.
• Write SOPs and test methods.
• Perform deviation and out of specification (OOS) investigations including leading root cause investigations and CAPA implementations.
• Maintain laboratory cell lines and reference materials used in flow and potency assays.
• Perform qualification and calibration / PM of equipment.
• Perform general activities in accordance to SOPs and laboratory quality systems, including change control, deviations, CAPA, training, audit readiness.

Qualifications

Minimum qualifications include a BS/MS in a biological science or equivalent level of experience, with a background in biologics and/or cellular therapeutics. Extensive hands-on experience in the performance of flow cytometry methods to characterize cells is required. Advanced familiarity with data analysis software packages such as FlowJo, Miltenyi MACSQuantify, BD FACSDiva, etc. is also required.

• Quality Control Analyst III: Minimum 5 years (2+ years MS) of experience.
• Quality Control Analyst IV: Bachelor’s or master’s degree in a life sciences field with 8-10 years (8+ years MS, 6+ years PhD) of experience.

Skills

• Extensive hands-on experience in the development, optimization, validation, and routine performance of flow cytometry methods to characterize cells using analyzers such as Miltenyi MACSQuant, BD FACSCanto/LSR, Guava easyCyte or equivalent.
• Advanced familiarity with data analysis software packages such as FlowJo, Miltenyi MACSQuantify, BD FACSDiva, etc.
• Familiarity with data analysis/statistical software packages (e.g. FlowJo, JMP, etc.).
• Strong communication and writing skills with demonstrated ability to work in a dynamic team environment.

Benefits

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

Pay

The annual base salary range for this position is from $93,163 to $139,714 for a Quality Control Analyst III, and from $104,458 to $165,090 for a Quality Control Analyst IV, with pay offered based on experience and qualifications.

Schedule

No specific schedule information is provided, but the role is expected to work in a dynamic team environment.