Materials Quality Expert for Cell Therapy

1 maand geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd

At Galapagos, a pioneering Biotech company with global presence, we're driven by a singular purpose: to change lives through life-improving medicines. With headquarters in Mechelen, Belgium, and offices across Europe and the US, we're shaping the future of healthcare.

We're seeking a highly skilled Materials Quality Consultant to join our Cell Therapy organization in Leiden, Netherlands, on a 6-month contract basis. As a trusted advisor, you'll play a pivotal role in transitioning our Incoming Goods process from Phase I/II Clinical to Phase III/Commercial standards.

Scope of the Job

We need an experienced Materials Quality Consultant to:

  • Draft a comprehensive risk assessment for QC and MFG materials, ensuring compliance with industry guidelines and regulations.
  • Define Full vs Reduced testing requirements for materials, balancing quality, reliability, and cost-effectiveness.
  • Cordinate material qualifications, testing, and documentation, guaranteeing seamless integration with existing processes.
  • Evaluate and recommend suitable contract testing labs, considering quality, reliability, and cost-effectiveness.
  • Collaborate with the development team to establish in-house analytical development processes and methodologies.
  • Support QC management in implementing a revised incoming goods strategy, ensuring efficient implementation and minimal disruption.
  • Stay updated on industry trends, regulations, and best practices related to materials quality in manufacturing and quality control settings.

Your Role

As a Materials Quality Consultant, you will be responsible for drafting a comprehensive risk assessment, defining testing requirements, coordinating material qualifications, evaluating contract testing labs, collaborating with the development team, supporting QC management, and staying updated on industry trends.

Key Requirements

To succeed in this role, you will need:

  • A strong background in Materials Quality Management, with experience in transitioning processes from Phase I/II Clinical to Phase III/Commercial standards.
  • Excellent knowledge of industry guidelines, regulations, and best practices related to materials quality.
  • Proven ability to coordinate material qualifications, testing, and documentation, as well as evaluate and recommend contract testing labs.
  • Strong collaboration and communication skills, with the ability to work effectively with cross-functional teams.
  • Ability to stay up-to-date on industry trends, regulations, and best practices related to materials quality.

Salary

The estimated salary for this role is €80,000 - €100,000 per annum, depending on experience.

About Us

Galapagos is a dynamic and growing Biotech company with a passion for changing lives through life-improving medicines. We're committed to innovation, excellence, and teamwork, and we're looking for talented individuals who share our vision.

Benefits

We offer a competitive package including salary, benefits, and opportunities for professional growth and development.



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