Process Team Lead

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 21, 2020
Ref
R0014931
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 is seeking a highly motivated individual with cell therapy or biopharmaceutical experience to coordinate development activities for Kite's CAR T cell programs and represent Process Development on the internal life-cycle Operations Team.
  • Develop and ensure delivery of Process Development portion of CMC strategy in alignment with program, operations team, and organizational CMC strategy.
  • Represent Process Development function on the Operations Team as defined by the OT charter
  • Together with the other Operations Team members, set the product's goals and CMC strategy
  • Act as product advocate within PD and at Operations Teams.
  • Lead Process Development Team (PDT) and work within Process Development to execute the PD portion of product goals and CMC strategy
  • Lead Process Development Team through critical data analysis, activity planning, and experimental review cross-functionally
  • Identify Process Development risks and develop mitigation plans.
  • Enable quick and robust decision making through effective communication
  • Supply required process information to support regulatory filings and review technical portions of Kite regulatory documents
  • Review technical documentation (project plans, reports, protocols, etc.)
  • Engage with Process Development teams (including Process Design and Analytical Development) to develop project schedules that align with program timelines
  • Lead cross-PD functional coordination and alignment for study execution
  • Partner with MSAT on process and method readiness in preparation for Tech Transfer
  • Monitor project execution for all program deliverables
  • Coordinate activities for partnered programs as necessary
  • Support outsourced development activities
  • Disseminate information throughout PD, escalating as appropriate
  • Other duties as assigned


Requirements:
  • Bachelors +10 years, Masters +8 years, or PhD +2 years within a scientific discipline.


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.