Description
Military Veterans are Encouraged to Apply.
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
Kite Pharma Analytical Development is looking for a highly motivated and talented Research Scientist (RS) with a background in immunology and/or cancer biology stem or cell therapy scientific principles, to lead the development of immunoassays, impurities assays, and cell-based potency assays for Kite's innovative broad-spectrum allogeneic cell therapy pipeline. The ideal candidate will have an extensive experience in HTP method development/qualification/validation of molecular (qPCR/ddPCR) and cell-based assays using traditional ELISA/Alphalisa/TR-FRET platforms. The successful candidate will be responsible for independently designing, planning and executing analytical method development of immunoassays and cell-based bioassays using Quality by Design (QbD) and design of experiment (DOE) approaches.
The ideal candidate will have an extensive experience in method development, method qualification/validation of immunoassays, molecular (qPCR/ddPCR) and cell-based assays. The successful candidate will work as an individual contributor and generate, analyze, interpret, present experimental data, and carefully document resultant information. The RS will author, review, and edit test methods, SOPs, technical reports, and assist in the technical review of CMC sections and supporting documents for regulatory filings. This role will provide an excellent opportunity of growth that will expand over time including mentoring and leading the junior team members.
Responsibilities and Duties:
• Independently design, execute and document analytical method development and qualification in support of process development, product release and stability, and product characterization of allogeneic CAR based cell therapy drug products
• Employ quality by design (QbD) and design of experiment (DOE) approaches for method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
• Serve as a SME for Analytical Development and responsible for knowledge/tech transfer of in-process and product characterization/release methods across Kite sites.
• Use forward looking perspective to contribute towards strategic (go/no-go) decisions as well as recommend new technologies for the Process Development team to pursue.
• Participate as a key member in cross-functional teams that align on strategies to characterize in-process and product attributes in Kite cell therapy products.
• Function independently in non-routine development activities and project goals.
• Author and review technical documents (e.g., development reports, SOPs, and technical reports).
• Maintain accurate documentation of experiments in ELN and reports.
• Function as a key contributor to Process Development knowledge by remaining up to date on scientific literature and the newest developments in relevant fields.
• Effectively communicate scientific findings pertaining to process/drug development via external and internal presentations, publications, patents, white papers, etc.
• Demonstrate leadership traits through team participation, internal consulting, and mentoring of junior team members.
• Work closely with clinical and commercial QC during knowledge, method transfer and co-qualification and/or validation.
• Develop experimental approaches using new analytical technologies.
• Maintain, calibrate and operate analytical equipment and instruments.
• Ensure that departmental areas are maintained per 5S guidelines.
Basic Requirements
• 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:
• In-depth knowledge of T cell biology and immune cell therapy
• Proficiency in designing and optimization of T- and NK-cell potency assays including target tumor cytotoxicity, cytokine analysis etc. is strongly desired.
• Expertise in analytical method development and qualification of plate-based immunoassays, impurities assays, and molecular biology (e.g. qPCR, ddPCR, ELISA, Luminex, TR-FRET).
• Expertise in aseptic mammalian cell culture techniques, human immune cell primary culture, and isolation/expansion of immune cells is required.
• Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.
• Excellent skills in Microsoft Office, data analysis software (e.g. JMP, Graphpad Prism, Geneious, SoftMax Pro), and other applications.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Evidence of high level of scientific expertise demonstrated through scientific publications, literature review and scientific conference participation is preferred.
• Overall understanding of drug development process and its impact on projects, goal and timelines is preferred.
• Experienced in establishing and maintaining internal and external collaborations, especially with outside centers of excellence in field of specialization.
• Excellent oral and written communication and presentation skills.
• Understanding of GxP is preferred.
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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 . Sign up to on Twitter at .
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Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
