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.
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Kite is seeking an Associate Scientist, Analytical Ops to take on critical roles to support quality control lifecycle management of vector related activities. The person in this role will contribute to team projects, be a role model, mentor to junior staff, and take ownership of important quality control tasks.
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Responsibilities:
- Establish and support strategies for analytical and micro testing in the vector process to comply with USP/ICH/EU regulations, GMP/GLP requirements, and industry practices
- Provide technical leadership and support for vector related method optimization, qualification and routine testing
- Collaborate closely with analytical development and quality control groups to support and/or provide oversite in the execution of method development/optimization, characterization, troubleshooting, transfer and validation
- Manage and ensure QC equipment/software life cycle and support review and approval of equipment qualification, calibration/PM, periodic review and de-commissioning as applicable
- Author/review test methods, SOPs and technical protocols/reports
- Provide support/review of and ensure lifecycle management of vector product sampling and QC testing plans
- Attend cross-functional team meetings as needed to align vector product testing as well as routine operation
- 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
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Basic Qualifications:
- Master’s Degree and 3+ years’ experience OR
- Bachelor’s Degree and 5+ years’ OR
- High School Degree and 9+ years’
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Preferred Qualifications:
- 5+ years’ experience in Cell Biology, Immunology, Molecular Biology, Virology
- Extensive hands-on experience with development and routine testing assays for vector release and characterization including data analysis
- Strong background in microbiology methods (i.e. endotoxin, sterility, bioburden, etc.)
- 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
