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Quality Control Supervisor

United States - California - El SegundoQualityRegular

Descripción del trabajo

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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