Technical Operations Specialist

7 dagen geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd

Galapagos' Mission

We are 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 Focus

Our historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis and in ulcerative colitis.

Expanding Our Pipeline

We are now entering an exciting new chapter 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.

Our Acquisitions

Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies.

The Role

We are seeking a Manufacturing Specialist 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.

Responsibilities

  • Provide technical support through technology transfers and clinical manufacturing.
  • Be SME in aseptic training and demonstrate a strong commitment to patients.
  • Support technology transfer activities for the decentralized point-of-care manufacturing sites, including production training, aseptic operator and process validation, process qualification runs, and operational readiness.
  • Provide 24/7 technical support service for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products that meet quality/regulatory requirements.
  • Relay technical information and mentor peers, contributing with technical training both, hands-on as well as documentation.
  • Use technical writing to write and review electronic batch records, SOPs, protocols & reports.
  • Closely collaborate with Quality Assurance, and other departments in order to support release of short vein-to-vein products.

Reporting Line

The Manufacturing Specialist reports to the Manufacturing Manager.



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