Associate Scientist, Analytical OpsUnited States - California - El SegundoQualityRegular
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
Kite is seeking an Associate Scientist, Analytical Ops to take on critical roles to support analytical design and characterization of retroviral and lentiviral vectors to enable vector process design and manufacturing. The person in this role will contribute to team projects, be a role model, mentor to junior staff, and take ownership of important analytical tasks.
Responsibilities and Duties
- Establish strategy for vector analytics to comply with USP/ICH/EU regulations, GMP/GLP requirements, and industry practices.
- Provide technical leadership and expertise for vector method optimization, qualification and routine testing
- Develop and mentor direct reports to provide analytical testing including but not limited to cell-based potency assays for the RVV- and LVV-based gene therapy product development and commercialization.
- Interface with the process design and manufacturing teams in support of in-process testing and investigations.
- Collaborate closely with the method development and quality control groups to support method development/optimization, characterization, troubleshooting, transfer and validation.
- Author/review test methods, SOPs and technical protocols/reports.
- Provide subject matter expertise into the method performance review.
- Attend cross-functional team meetings as needed.
- May contribute to the writing and review of regulatory submissions.
- Assist with deviation, investigation, CAPA and change control activities at Kite pharma and contract labs, as needed
- Support in creating, maintaining, and conducting training activities
- Master’s Degree and 3+ years’ experience in Cell Biology, Immunology, Molecular Biology, Virology or related fields OR
- Bachelor’s Degree and 5+ years’ experience in Cell Biology, Immunology, Molecular Biology, Virology or related fields OR
- High School Degree and 9+ years’ experience in Cell Biology, Immunology, Molecular Biology, Virology or related fields.
- Extensive hands-on experience with development and routine testing assays for vector release and characterization including data analysis.
- Strong background in mammalian cell culture, flow cytometry, qPCR/ddPCR, and ELISA-based methods.
- Experience with next-generation sequencing platforms, library construction and computational bioinformatics analyses (i.e. Illumina systems).
- Familiar with data analysis software, such as MS Excel, PLA, JMP and SoftMax Pro.
- Experience and ability to use DOE for assay optimization and robustness.
- Knowledge of relevant USP/ICH/EU regulations, GMP/GLP requirements, and industry practices.
- Highly collaborative team player who demonstrates open communication.
- Strong scientific writing and presentation skills.
- Experience with viral particle characterization/physical titer methods
Does this sound like you? Apply today!