United States flag

Principal Scientist I, Analytical Ops - Process Development

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description

We are seeking a highly motivated individual to lead a 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 Principal Scientist will assume a leadership role in the development of analytical strategies for bioassays aligned with vector and cellular therapy 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

  • 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 bioassay/potency method development activities and life cycle from conception, development and qualification through method transfer to Quality Control and Kite partners and validation
  • Work closely with clinical and commercial QC during knowledge, method and tech transfer, and co-qualification/validation
  • Serve as SME and technical advisor on method validation, method transfer, comparability/bridging protocols
  • Evaluate and develop innovative technologies for use in and/or to advance bioassay/potency method development
  • Employ quality by design (QbD), design of experiment (DOE), and statistical approaches to method development to identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines
  • As applicable to bioassays, manage cell line development and characterization, expansion, and cryopreservation of master, working and single use (“ready to go”) cell banks
  • 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 to support regulatory filings
  • Collaborate closely with other key line functions and communicate complex data/decisions within department and cross functionally

Basic Qualifications

Advanced scientific degree (i.e. MD, PharmD, PhD) and 8+ years of industry/scientific experience

OR

Master’s Degree and 10+ years of industry/scientific experience

OR

Bachelor’s Degree and 12+ years of industry/scientific experience


Preferred Qualifications

  • Advanced degree (Ph.D.) in Bioengineering, Biotechnology, Engineering, Immunology, Cell Biology
  • Successful track record in leadership and people management within a development organization
  • Expertise in method development, validation and commercial life cycle of mammalian cell-based potency final product release assays in a GxP/regulated pharmaceutical industry setting
  • Extensive hands-on experience with the design, development, optimization, qualification and validation of novel bioassays and immunoassays across multiple platforms and technologies (e.g, ELISA, MSD, Envision, IncuCyte, flow cytometry and cell based – cytokine production, proliferation, phosphorylation, reporter and cytotoxicity assays)
  • Demonstrate advanced knowledge in T cell biology, T cell signaling pathways and mammalian cell culture including primary T cells
  • Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and appropriate statistical analyses (JMP experience preferred)
  • Knowledge of industry USP/ICH guidances for the development, qualification/ validation of functional cell-based assays and potency methods
  • Experience with viral vectors (RVV and LVV) and cellular therapy T cell products a plus
  • Excellent skills in Microsoft Office, data analysis software (e.g. PLA software, JMP, GraphPad Prism, FACSDiva, SoftMax Pro), and other applications
  • Excellent organizational, documentation, and interpersonal, verbal and written communication skills; adaptive learning, critical thinking, and the ability to work well in a team