Materials Quality Specialist

1 week geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd

We are Galapagos, a dynamic and growing Biotech company with a presence across Europe and the US, headquartered in Mechelen, Belgium.

We're on a mission to change lives by discovering and developing life-improving medicines. Our Cell Therapy organization in Leiden, NL, is seeking a highly skilled Materials Quality Consultant to support our transition from an Incoming Goods process suitable for Phase I/II Clinical to a process suitable for Phase III/Commercial.

Key Responsibilities:

  • Develop a comprehensive risk assessment for QC and MFG materials, considering relevant guidelines and regulations.
  • Define Full vs Reduced testing requirements for materials, ensuring compliance with industry standards and regulations.
  • Coordinate the qualification process for materials, ensuring appropriate testing, documentation, and compliance.
  • Identify and evaluate suitable contract testing labs for specific testing activities.
  • Collaborate with the development team to establish in-house analytical development processes and methodologies.
  • Assist QC management in implementing a revised incoming goods strategy.
  • Stay updated with industry trends, regulations, and best practices related to materials quality.

About the Role:

This is a 6-month contract position for a Materials Quality Consultant to support our Cell Therapy organization in Leiden, NL. The ideal candidate will have a strong background in quality assurance and materials science, with experience in drafting risk assessments and coordinating material qualifications.



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