Research Scientist, Flow Cytometry

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 02, 2020
Ref
R0015091
Required Education
Masters Degree/MBA
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

The Research Scientist will be responsible to develop flow cytometric analytical methods for QC release and characterization of cell therapy products, maturation of research analytical methodology into development and GMP, and analytical method technology transfer to and from Kite partners.They will analyze, interpret, and present experimental data, and carefully document resultant information.The successful candidate will also be responsible for the handling and maintenance of associated materials such as cells and reagents in established and controlled manner to ensure successful outcomes. They will author and review method development reports, test methods and SOPs, protocols, and assist in the technical review of CMC sections and supporting documents for regulatory filings.They will work on critical cross-functional projects with the Process Design, Research, Translational Medicine, and/or Quality Control teams to support analytical method and process development of Kite's engineered cell products.

Responsibilities and Duties
  • Design, execute and document multi-parameter flow cytometry analytical method development, qualification and immunophenotyping in support of process development, product release and stability, and product characterization of cell therapies in Process Development
  • Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines
  • Ensure proper cross-site alignment of flow cytometers in QC and AD organizations
  • Identify, generate, qualify and characterize appropriate analytical method controls for flow cytometric analytical methods
  • Execute and document cell line expansion and cryopreservation of master, working and single use cell banks with characterization of key surface markers by flow cytometry
  • Work closely with clinical and commercial QC during knowledge, method and tech transfer, and co-qualification/validation
  • Plan, execute, analyze, and document using GDP experiments that support routine development activities, innovation, investigations, and project goals
  • Write, review and edit accurate technical, development and qualification reports as well as SOP/maintenance/user requirements for relevant flow cytometry platforms
  • Provide technical guidance to junior staff, assign duties, review data, and reinforce regulatory concepts (cGMP)
  • Participate in group and department meetings, present scientific data, provide expertise in areas of responsibility
  • Maintain, calibrate and operate analytical equipment and instrumentation that is used routinely in execution of assays
  • Ensure that departmental area are maintained per 5S guidelines


Qualifications
  • Advanced degree (Ph.D.) in Immunology, Cell Biology with 0+ years, or related discipline with or M.S. in similar discipline with 6+ years of industry experience
  • Demonstrate knowledge of manufacturing of cellular therapy products, analytical method development for GxP, method qualification/validation, technology transfer, and process development
  • Experience in development and qualification of multi-parameter flow cytometry analytical methods for release in a QC/regulated environment
  • Demonstrate advanced knowledge in T cell biology and T cell signaling pathways
  • Knowledge of mammalian cell culture including primary T cells
  • Experience with FACS and magnetic bead cell sorting is a plus
  • Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis is a plus
  • Excellent skills in Microsoft Office and data analysis software (e.g. Prism, JMP, FlowJo, FACSDiva, CytEpert, SoftMax Pro)
  • Ability to think critically and demonstrate troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
  • Experience and aptitude in working in a multidisciplinary laboratory environment with moderate supervision
  • Comfortable in a fast-paced small company environment with minimal direction


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.