Principal Scientist, Bioassay

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 08, 2020
Ref
R0015998
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

We are seeking a highly motivated individual to lead a growing team developing cell-based analytical methods to support release and characterization of the mechanisms of action (MoA) of Kite's engineered cell therapy products. The ideal candidate will assume a leadership role in the development of analytical strategies for potency methods aligned with product CQAs to enable process development, product characterization, stability and release testing. The individual will grow, manage, and mentor a strong technical team to deliver new and optimized analytical methods, evaluate new analytical technologies, and perform platform assessment as part of analytical method lifecycle management. The candidate will work with the Process Design, Research, Translational Medicine, and/or Quality Control teams on critical cross-functional projects.

Responsibilities include, but are not limited to, the following:
  • Manage and provide strategic, technical and scientific leadership to a highly technical Bioassay analytical method development team
  • Responsible to advance and implement cell-based analytical methods as part of an analytical control strategy
  • Lead cell-based bioassay/potency method development activities from conception through optimization, qualification, and method transfer to Quality Control and Kite partners
  • Serve as SME and technical advisor on method validation, method transfer, comparability/bridging protocols
  • Evaluate and develop new technologies for use in and/or to advance cell-based bioassay method development
  • Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines
  • Identify, generate, characterize, and qualify appropriate analytical method controls
  • As applicable to cell-based assays, manage cell line development and characterization, expansion, and cryopreservation of master, working and single use ("ready to go") cell banks
  • Work closely with clinical and commercial QC during knowledge, method and tech transfer, and co-qualification/validation
  • Plan, execute, analyze, and use GDP to document 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 new technology platforms
  • Collaborate closely with other key line functions and communicate complex data/decisions within department and cross functionally


Basic Qualifications:
  • PhD in Bioengineering, Biotechnology, Engineering, Immunology, Cell Biology, or related discipline is preferred with 8+ years of industry experience
  • Masters Degree in Bioengineering, Biotechnology, Engineering, Immunology, Cell Biology, or related discipline is preferred with 10+ years of industry experience


Preferred Qualifications:
  • Successful track record in leadership and people management within a development organization
  • Expertise in method development and qualification of mammalian cell-based potency assays (e.g. co-culture assays, cytotoxicity assays, and proliferation assays) for release in a GxP/regulated environment
  • Experience in analytical method development and qualification of plate-based immunoassays, impurities assays, and molecular biology (e.g. RT-PCR, ddPCR, ELISA, MSD, Luminex, Envision)
  • Demonstrate advanced knowledge in T cell biology, T cell signaling pathways and mammalian cell culture including primary T cells
  • Experience with gene and cellular therapy T cell products
  • Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis
  • Experience with Good Documentation Practices
  • Excellent skills in Microsoft Office, data analysis software (e.g. Prism, JMP, FlowJo, FACSDiva, SoftMax Pro), and other applications
  • Ability to think critically and demonstrate troubleshooting and problem solving skills
  • Comfortable in a fast-paced small company environment and working under minimal direction


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

#IND123

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.