Quality Control Analyst IIIIV

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 worlds 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 worlds 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 equivalent 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 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.

Quality Control Analyst IV:

• Bachelors or masters degree in a life sciences field with 8-10 years (8 years MS 6 years PhD) preferably with a background in biologics and/or cellular therapeutics or equalvalent level of expereince.
• 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 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
• Leading and providing technical training to flow cytometry associates
  

PREFERRED QUALIFICATIONS:

• Hands-on knowledge of aseptic and cell culture techniques or equalvalent level of expereince.
• Experience with typical GMP Quality Systems (ex. Document Control Deviations CAPA Change Control Risk Assessment and external/internal audits etc.).
• Experience in developing and validating flow cytometry or other assays for biologics products in a GMP environment.
• Background in biologics quality control including testing and/or characterization of monoclonal antibodies recombinant protein antibody-conjugates or other protein therapeutics.
• Experience with immunoassays and protein analytics such as ELISA Mass spectrometry and HPLC methods.

Quality Control Analyst III: The annual base salary range for this position is from $93163 to $139714 and pay offered will be based on experience and qualifications.

Quality Control Analyst IV: The annual base salary range for this position is from $104458 to $165090 and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

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).