Job DescriptionResponsibilities (included but are not limited to):
• Perform analytical testing using ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry to support lot release and routine stabuility testing, test result review and data verification.
• Support product quality review by performing method monitoring/method performance verification, tracking and trending invalids, test results, reagent use/reference control use, OOTt data as required per applicable SOPs.
• Maintain, calibrate and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry.
• Assist with deviation, investigation, CAPA and change control activities at Kite pharma and contract labs.
• Review data for quality, consistency, and accuracy Responsible for tracking of logbooks lifecycle and review process.
• Identify gaps, recommend process improvements, and author/review change controls to implement change to qualified processes and or equipment at Kite pharma and contract labs.
• Revise, and review SOPs, protocols, and technical reports.
• Support training activities.
• Support activities related to the transfer and validation of analytical methods from Clinical to Commercial QC, and Commercial QC to external testing sites
• Support inspection readiness activities.
• Participate in continuous improvement projects and activities
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
The salary range for this position is: $80,325.00 - $103,950.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
