Quality Control Analyst III​/IV

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.

Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

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. The position will be the primary subject matter expert (SME) for flow-cytometry based cell characterization, potency, and release assays, as well as qPCR, aseptic techniques, and related testing activities in our GMP laboratory environment.

The position will lead assay development, validation, and transfer activities for flow-based methods and perform testing as needed. Cross training in other cell-based potency, biologics, and microbial assays will be required.

• 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.

MINIMUM QUALIFICATIONS:

Quality Control Analyst III:

• BS/MS in a biological science or equalvalent level of expereince.
• Minimum 5 years (2+ years MS) with a background in biologics and/or cellular therapeutics.
• Extensive hands‑on experience in the performance of flow cytometry methods to characterize cells (e.g. using a, Canto, LSR, Guava etc.).
• 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 easy
  
  Cyte or equivalent.
• Advanced familiarity with data analysis…