Veterans Preferred - Research Scientist - Cell Biology

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.

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Job Description

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.

Basic Requirements
• 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

Additional Qualifications

• 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.

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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 www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.