Lead Site Manufacturing Technology (SMT)
Gilead
IT
7 gg fa

Job Description

As Lead SMT you’ll be joining a newly formed team, in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity.

You’ll be reporting to the Director Manufacturing.

About Kite Pharma, A GILEAD Company

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 Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.

We’re building a state-of-the art manufacturing site in the Netherlands (Amsterdam-Hoofddorp).

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

You’ll be responsible for building up and leading the SMT team for the new to build manufacturing site in Hoofddorp (NL).

In this role you and your technical team will be responsible for deviations, CAPAs, change control and front line support for Kite’s commercial manufacturing site producing autologous T cell therapy products.

Key responsibilities :

  • Lead the technical team responsible for deviations, CAPAs, change control and front line support
  • Investigates, identify root cause for critical deviations and determine CAPA for manufacturing
  • Maintain the Manufacturing training program, ensure compliance with manufacturing training metrics in close collaboration with manufacturing management
  • Establish data analytics to serve as metrics
  • Support incoming tech transfers from Product Development
  • Author technical reports and protocols in support of cGMP activities
  • In collaboration with Product Development and Manufacturing evaluate and implement continuous improvement initiatives
  • Represent Kite as an SME in regulatory inspections and quality audits, both internal and external.
  • Skills :

  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Build and maintain a high performing team
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Experience & Qualifications :

  • Minimum of 10 years of pharmaceutical manufacturing, technology transfer or process development experience including at least 5 years as a people manager
  • Cell culture or aseptic processing experience
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is an advantage
  • Proven track record of leading and managing cross functional teams
  • Knowledge of data management tools and statistical process controls
  • Bachelors / Master’s degree in Biochemistry, Chemical Engineering, Biotechnology or equivalent
  • Would you like to know more before you apply? Please contact Jose van de Beek - Talent Acquisition Business Partner, via : CareersEU kitepharma.com.

    Only candidates in possession of a valid EU work permit will be considered.

    Recruitment agencies : We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.

    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.

    For Current Kite Pharma Employees and Contractors :

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

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