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Senior Manager, Manufacturing

Manufacturing | El Segundo, CA | Full Time

Job Description

About Us:

Kite Pharma, Inc., is a biopharmaceutical company based in Santa Monica, California. Kite is 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. For more information on Kite, please visit www.kitepharma.com.

We are seeking a highly effective Senior Manager, Manufacturing to be responsible for managing a team of supervisors and cell culture manufacturing specialists in a commercial pharmaceutical environment.  In this role you will report to the Senior Director of Manufacturing. This is 2nd shift position, Monday-Friday 3:00pm-11pm.

Responsibilities (include but are not limited to):

  • Supervise the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment
  • Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
  • Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture
  • Execute production and resource schedule against operational plan
  • Ensure performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
  • Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
  • Complete the final review of completed manufacturing documentation per compliance standards and established timelines
  • Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
  • Interact with outside vendors and senior management
  • Participate in multi-functional project teams, as necessary
  • Take corrective action to bring about required changes using change control procedures
  • Other duties as assigned

Requirements:

  • Bachelor’s degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 12 years of experience managing a manufacturing team in the biotechnology or biologics industry
  • Able to build and manage a team as well as train entry-level personnel
  • Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
  • Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
  • Expert knowledge of electronic quality systems
  • Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely

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