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Scientist, Analytical Development

Company: Kite Pharma
Location: Santa Monica
Posted on: May 13, 2022

Job Description:

Job DescriptionAnalytical development is seeking a talented and highly motivated scientist with experience in analytical method development of cell-based potency/safety assays for Kite's innovative autologous and allogeneic cell therapy pipeline for cancer treatment. The successful candidate will be a part of team responsible for the development and technology transfer of cell based analytical methods for a broad spectrum of CAR-based cell therapy products to support process characterization and product release. The ideal candidate will have strong knowledge of immunology, cancer biology, or cell therapy scientific principles. As an independent contributor, the candidate will be responsible for the designing, planning and execution of cell-based analytical methods using Quality by Design (QbD) and Design of Experiment (DoE) approaches.The candidate will plan, execute, analyze and review experimental data, and carefully document resultant information and assist in the technical review of CMC sections and supporting documents for regulatory filings. The candidate will serve as an SME on cell-based assays on cross-functional teams and in interactions with external organizations and deliver QC-viable cell-based potency assays for transfer to clinical and commercial sites.Responsibilities and Duties

  • Independently design, execute and document analytical method development and qualification/validation for release and stability methods for CAR-based cell therapy drug products.
  • Lead the method optimization, perform data analysis, data review, data reporting and troubleshooting of potency release methods.
  • Serve as SME for AD and responsible for knowledge and technology transfer for product release methods within Kite and its external partners.
  • 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.
  • Prepare data packages for submission to regulatory agencies.
  • Author, review and edit technical documents, including SOPs, protocols and reports.
  • Maintain, calibrate and operate analytical equipment's.
  • Use good documentation practices (GDP) to document laboratory activities and ensure data integrity.
  • Provide user training on instruments, sample analysis, and cross-train analysts on cell based analytical methods.
  • Work closely with clinical and commercial QC during knowledge, method transfer and co-qualification and/or validation.
  • Maintain laboratory per 5S guidelines and assist with other assigned laboratory administrative duties.
  • Additional responsibilities may be assigned to reflect changes in business process.Basic qualifications:
    • PhD in Cellular Biology, Immunology or Molecular Biology with 0+ years of industry/research experience or
    • MS with 6+ years of industry/research experience or
    • BS with 8+ years of industry/research experience.Preferred qualifications
      • Strong scientific background in immunology, cancer biology or cell biology.
      • In-depth knowledge of T-cell functional assays (e.g. activation, proliferation, cytokine profiling, etc.) is strongly desired.
      • Proficiency in aseptic human immune and tumor cells, co-culture cytotoxicity assays, cell growth analysis is required.
      • Experience in clonal cell selection and cell banking principles is preferred.
      • Comprehensive understanding of ELISA, FRET and other proximity binding assays is required.
      • Experience in flow cytometry and good understanding of acquisition software's such as FACSDiva, CytExpert, etc.
      • Experience in analytical method development and qualification of cell-based potency assays is preferred.
      • Knowledge of QbD approaches to analytical method development including risk and gap assessments, DOE and statistical analysis is a plus.
      • Ability to think critically with strong analytical and problem-solving skills and excellent organization and communication skills.
      • Previous experience with cell therapy products and understanding of GxP is a plus.
      • Excellent skills in Microsoft Office, data analysis software's (e.g. JMP, Graphpad Prism, SoftMax Pro, FlowJo), and other applications
      • Evidence of high level of scientific expertise demonstrated through scientific publications, literature review and scientific conference participation is preferred.
      • Excellent written communication skills as demonstrated through technical report writing and/or regulatory filings.
      • Highly organized, attention to detail with ability to focus and deliver in a fast-paced environment.#LI-ML1#IND123

Keywords: Kite Pharma, Santa Monica , Scientist, Analytical Development, Other , Santa Monica, California

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