Scientist, Flow CytometryUnited States - California - Santa MonicaProcess/Product Development & OperationsRegular
Kite Pharma Analytical Development is looking for a talented and highly motivated Research Scientist with a background in immunology and/or cancer biology, to lead method development for qualification of and release of drug substance and drug products for T cell therapies. The ideal candidate will have an extensive knowledge of cellular biology and immunology.
The RS 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 flow cytometry and cellular assays.
The candidate will generate, analyze, interpret, and present experimental data, and carefully document resultant information. They 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. In partnership with Research and Translational Medicine, the Research Scientist will work cross-functionally to identify new technologies and opportunities for continuous process/product improvement.
This role has a significant scope of growth to evolve and expand over time to include mentoring junior team members, functioning as a T cell biology SME and working with key stakeholders to build and advance product understanding.
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 drug substance (vector) and T cell 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.
• Act as a SME for Analytical Development and be accountable for knowledge/technology transfer into Quality Control sites.
• Use forward looking perspective to contribute towards strategic (go/no-go) decisions as well as recommend new technologies for the Analytical Development team to pursue.
• Participate as a key member in cross-functional teams and work collaboratively to align on business strategies
• Work closely with clinical and commercial QC during knowledge, method transfer and co-qualification.
• 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
• Develop experimental approaches using new analytical technologies.
• Maintain, calibrate and operate analytical equipment and instruments.
• Ensure that departmental areas are maintained per 5S guidelines.
• Ph.D in Cellular Biology , Immunology or Molecular Biology with 0+ years of academic/industry experience OR
• MS with 6+ years of industry experience; OR
• BS with 8+ years of industry experience
- Strong scientific background in cellular biology, immunology and/or cancer biology.
- Strong experience in flow cytometry technology platforms and associated data analysis
- Expertise in analytical method development and qualification of flow cytometry based assays, cell line development and cellular based assays.
- Experience with cell culture such as aseptic techniques, primary cell line development and expansion and isolation techniques of immune cells is a plus.
- Knowledge of QbD approaches to analytical method development, DOE and advanced statistical analysis.
- Excellent skills in Microsoft Office, data analysis software (e.g. JMP, Graphpad, Prism, FlowJo, Diva, Cytexpert), 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 CAR T drug development process.
- Experienced in establishing and maintaining internal and external collaborations.
- Excellent oral and written communication and presentation skills.
- Understanding and experience of GxP is preferred.