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 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:

• Bachelor’s or master’s 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 $93,163 to $139,714, and pay offered will be based on experience and qualifications.

Quality Control Analyst IV: The annual base salary range for this position is from $104,458 to $165,090, 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).