Quality Control Supervisor

Job Description

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies.  We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs. 

Kite is seeking a highly-motivated individual to join us as a Supervisor in the Commercial Quality Control (QC) organization. This individual will lead a team that is responsible for analytical Quality Control activities in support of Clinical and Commercial Manufacturing at our El Segundo location. The candidate will have significant cross-functional interaction with personnel from QC, Quality Assurance, Manufacturing and Corporate teams.

Schedule: Sunday through Wednesday, 6:30 a.m. – 5 p.m. (available to work weekends and holidays)

Responsibilities:

• Lead a team of high-performing individuals, with focus on individual development in support of greater team achievement
• Drive a culture of Operational Excellence in the group
• Supervise Analytical QC testing and various other support activities performed in the Analytical QC Lab
• Expectation includes a hands-on, team-oriented approach to problem-solving, planning, and people-management
• Responsible for OOS, lab and protocol deviations, and corrective action plan implementation when necessary
• Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections
• Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
• Develop, revise and review SOPs
• Responsible for QC training.  Monitor the GMP systems currently in place to ensure compliance with documented policies
• Work with internal and external resources to maintain analytical equipment in an optimal state.
• Oversee purchase and qualification of equipment, materials and media required for routine testing and reagent qualification
• Lead lab investigations, write deviations, and change controls
• Responsible for Data trending, control charts and metrics

Basic Qualifications:

• Master’s Degree and 3+ years of Quality experience in a GMP environment OR
• Bachelor’s Degree and 5+ years of Quality experience in a GMP environment OR
• High School Degree and 9+ years of Quality experience in a GMP environment

Preferred Qualifications:

• Degree in Biochemistry, Cellular Biology or Molecular Biology
• Demonstrated ability to develop, coach and mentor employees
• Ability to effectively negotiate and build collaboration amongst individual team members
• Experience with biologics with cellular therapies
• Experience with ddPCR, qPCR, Flow Cytometry, ELISA  or Mammalian Culture
• Familiarity with FDA, ICH and GMP guideline
• Ability to think critically and demonstrate troubleshooting/problem solving skills
• Strong attention to detail
• Experience in conducting lab investigations, writing deviation reports, implementing CAPA and initiating/implementing change controls
• Experience with a Lab Information Management System (LabVantage, Sample Manager, LabWare, StarLIMS or similar)
• 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

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