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Global External Testing Specialist for Contract Testing Labs

United States - California - El Segundo, United States - California - Oceanside, United States - California - Santa Monica, United States - Maryland - Frederick, United States – RemoteManufacturing Operations & Supply ChainRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

 

We are seeking a highly motivated individual to join us as a Global External Testing Specialist to support Kite’s global network of Contract Testing Labs (“CTL”) within the External Supply and Partnerships team embedded within the Global Supply Chain Organization.  The individual will report to the Associate Director, External Supply and Partnerships at Kite.

 

The Global External Testing Specialist, internally known as a Supply Chain Specialist IV, will have opportunities to work with and collaborate with different functions and partners across Kite’s Technical Operations organization (e.g. Quality Control, Analytical Development, Quality Assurance, Regulatory, Manufacturing, and Supply Chain), as well as multiple CTL Partners. The ideal candidate will have strong organization and communication skills, technical knowledge (biologics/gene and cell therapy and raw material testing operations, GMP regulation and drug development life cycle), and network-based thinking (tact, contract negotiation, project management).

 

This position can be a remotely based position for the right candidate or located at one of our sites in either Frederick, MD; Santa Monica, CA; El Segundo, CA; or Oceanside, CA.

 

Responsibilities of the Global External Testing Specialist for Contract Testing Labs include, but are not limited to: 

  • Performs a wide variety of activities to ensure external testing needs meet supply requirements for commercial and clinical programs

  • Gathers user requirements around method inquiries from end users and develops requests to be sent to contract test labs

  • Collaborates with internal and external Quality Control teams to resolve technical and method issues, and communicates path forward to stakeholders

  • Tracks and communicates viral vector and raw material sample testing status to internal stakeholders and leadership teams

  • Supports development of a raw material forecasting tool to provide to CTL partners

  • Collaborates with Sourcing to ensure all quotes, statements of work, change orders, and purchase orders are in place to prevent testing delays

  • Approves CTL invoices and manages PO spend for all CTL partners

  • Acts as the first point of contact for CTL invoice resolution

  • Supports budget forecasting for CTL spend across multiple Kite sites

  • Partners with Sourcing to identify CTLs for new scopes of work

  • Facilitates and effectively communicates information between Kite and external test partners involving method, operations, and finances

  • Initiates deviations, change controls, or CAPAs related to CTL operations

  • Develops, generates, evaluates, and presents performance metrics reports and dashboards

 

Basic Qualifications:

  • MS/MA Degree 2+ years’ experience of cGMP and/or Contracting Testing and/or Operations and/or Supply Chain OR

  • BS/BA Degree with 4+ years’ experience of cGMP and/or Contracting Testing and/or Operations and/or Supply Chain OR

  • Associate Degree with 5+ years’ experience of cGMP and/or Contracting Testing and/or Operations and/or Supply Chain OR

  • High School Degree with 6+ years’ experience of cGMP and/or Contracting Testing and/or Operations and/or Supply Chain

 

Preferred Qualifications:

  • Knowledge of Good Manufacturing Practices (GMPs) and quality systems

  • Experience working in a GMP test laboratory and experience performing testing to support release of raw materials or final product

  • Experience working with contract test laboratories or other external contract organizations

  • Technical knowledge of test methods such as identification, sterility, endotoxin, mycoplasma, particulate matter, pH, and osmolality

  • Working knowledge of collaboration within a matrix environment

  • Diplomacy skills and ability to proactively identify and mitigate risks

  • Demonstrates outstanding organizational skills with the ability to multi-task and prioritize

  • Strong analytical and problem-solving skills and strong data analytics skills (Tableau, Excel)

  • Excellent oral and written communication skills

  • Demonstrates discipline in planning and plan execution

  • Quick learner of new technology/process/work environment and ability to translate learning to work plans for improving business performance

  • Patient-centric mindset

  • Superior work ethic and a strong personal desire for success