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Manufacturing Specialist

1 maand geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd
Galapagos Manufacturing Specialist - EU

We are Galapagos, a dynamic and fast-growing Biotech company dedicated to making a lasting positive contribution to society through the discovery of innovative therapies for diseases with large unmet medical need.

Our mission is to expand and diversify our pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. We are looking for a Manufacturing Specialist - EU to join our Manufacturing Team in Leiden.

Scope of the Job

The Manufacturing Specialist provides operational expertise to our decentralized point-of-care manufacturing units for CAR-T cell therapies. Our new colleague has a critical role in technical support through technology transfers and clinical manufacturing, is SME in aseptic training, and demonstrates a strong commitment to patients.

Responsibilities:
  • Provide technical support for the decentralized point-of-care manufacturing sites, including production training, aseptic operator and process validation, process qualification runs, and operational readiness.
  • Collaborate with Quality Assurance, and other departments to support release of short vein-to-vein products.
  • Contribute to technical training, both hands-on and documentation.
  • Use technical writing to write and review electronic batch records, SOPs, protocols & reports.

The Manufacturing Specialist reports to the Manufacturing Manager.