Associate Scientist

The Associate Scientist will be responsible to develop and transfer analytical methods for Quality Control (QC) lot release, stability, or characterization of cell therapy products.  The successful candidate will collaborate with cross-functional teams to plan and execute development of state-of-the-art, robust molecular biology based analytical methods (e.g. ddPCR, ELISA) using Quality by Design (QbD) and design of experiment (DOE) approaches. The Associate Scientist will be responsible to analyze, interpret, and present experimental data, and carefully document resultant information.  They will author and review study plans, method development and technical reports, test methods and SOPs.  The Associate Scientist will collaborate with the Process Design, Research, Translational Medicine, and/or QC teams on projects that enable manufacturing process, formulation, and drug product development of Kite’s therapeutics. 

• Execute and document analytical method development and qualification to enable process development, product release and stability, as well as product characterization of drug substance (vector) and T cell therapy products
• Support the identification, generation, characterization and qualification of appropriate critical reagents and analytical method controls
• Participate in analytical method transfer activities to clinical and commercial QC (knowledge transfer, training QC staff, and review of subsequent data and training documents)
• Author, review and edit technical, development and qualification reports
• Train technical staff and provide technical guidance to junior staff, reinforcing regulatory concepts (cGMP)
• Perform assessment of new technologies and/or assay formats to drive continuous improvement
• Maintain, calibrate and operate analytical equipment and instruments
• Support testing as needed to enable process development and innovation, investigations
• Ensure that departmental areas are maintained per 5S guidelines

• MS degree in Biology, Immunology, Molecular Biology with 0+ years of industry experience or
• BS degree in Biology, Immunology, Molecular Biology with 2+ years of industry experience
• AS degree in Biology, Immunology, Molecular Biology with 4+ years of industry experience
• High School Diploma with 5+ years of industry experience

Additional Qualifications

• Advanced knowledge in T cell biology and T cell signaling pathways
• Experience with mammalian cell culture
• Demonstrated knowledge of analytical method development, method qualification/validation, technology transfer
• Experience with molecular biology and plate-based immunoassays (e.g. qPCR, ddPCR, ELISA, MSD) required
• Experience with flow cytometry, impurities assays, and/or mammalian cell-based potency assays including co-culture assays, cytotoxicity assays, and proliferation assays a plus
• Experience with gene and cellular therapy T cell products a plus
• Experience with Good Documentation Practices
• Experiences with using Microsoft Office, data analysis software (e.g. Prism, JMP, FlowJo, FACSDiva, SoftMax Pro), and other applications
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced environment with minimal direction
• Excellent interpersonal, verbal and written communication skills

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.