Sr. Research Scientist I, QC Analytical Technical Services

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.

For Current Kite Pharma Employees and Contractors:

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

Job Description

Kite, a Gilead Company, is seeking a highly-motivated individual to join us as a Sr. Research Scientist I in the QC Analytical Technical Services group within Clinical Quality Control (CQC). The individual will work within the RDMC-W QC organization and will have significant cross-functional interaction with personnel from Commercial QC, Analytical Development (AD), Quality Assurance and Manufacturing teams.

The Sr. Research Scientist I will lead the QCA Technical Service group and have an overall responsibility, among others, for providing technical expertise for the tech transfer, qualification of analytical microbiology test methods from AD, driving method validation studies per regulatory phase appropriate guidelines, supporting cross-site method transfer activities, managing analytical deviation/investigation, assisting in improvement of quality metrics and promoting a culture of quality and compliance within CQC.

Key Responsibilities include (but not limited to):

• Support lifecycle management of clinical release methods by evaluating and proposing enhancements to the test methods.
• Support activities related to the transfer and validation of analytical methods from AD to Clinical QC, and commercial QC to external testing sites.
• Assist with deviation, lab investigations, CAPA and change control activities at Kite pharma and contract labs, as needed.
• Support inspection readiness activities.
• Develop, revise and review SOPs, protocols and technical reports, as needed.
• Participate in generating and providing training using instruction led training material.
• Responsible for generating trending charts for monitoring method performance, product quality and/or test method invalid rates.

Qualifications:

• Ph.D. with 3+ years or Master with 8+ years of experience in a GMP environment
• Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, qPCR, ddPCR, ELISA, Cell Viability measurement, etc. Familiarity with analytical automation is a plus.
• Experience in performing method validation studies and supporting method transfer activities
• Familiarity with FDA, ICH and GMP guidelines, as they pertain to operating within a QC lab
• Ability to think critically and demonstrate troubleshooting/problem solving skills
• Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls
• Excellent skills in Microsoft Office, data analysis software, and other related applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

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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For Current Kite Pharma Employees and Contractors:

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