Manufacturing Specialist

1 week geleden


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

We are seeking a highly skilled Manufacturing Specialist to join our team in Leiden. As a key member of our Manufacturing Team, you will provide operational expertise to our decentralized point-of-care manufacturing units for CAR-T cell therapies.

Key Responsibilities:
  • Provide technical support for technology transfer activities, including production training, aseptic operator and process validation, process qualification runs, and operational readiness.
  • Offer 24/7 technical support service for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, and coordination of subject matter experts to ensure timely release of CAR-T products that meet quality/regulatory requirements.
  • Collaborate with Quality Assurance and other departments to support release of short vein-to-vein products.
  • Develop and maintain technical documentation, including electronic batch records, SOPs, protocols, and reports.
Requirements:
  • Strong technical expertise in aseptic manufacturing and CAR-T cell therapy.
  • Excellent communication and problem-solving skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
About Galapagos:

Galapagos is 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.


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