Manufacturing Specialist, PoC, Specialist

1 maand geleden

Leiden, Nederland Galapagos Voltijd

Pleased to meet you, we are Galapagos , a dynamic fast growing Biotech company. We’re in the business of changing lives.

Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos’ 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 in 2020 and in ulcerative colitis in 2021.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio , we are propelling ourselves into next-generation cell therapies.

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:

Able to frequently travel and 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. Able to relay technical information and mentor peers. Contribute with technical training both, hands-on as well as documentation. Able to use technical writing to write and review electronic batch records, SOPs, protocols & reports. Closely collaborates with Quality Assurance, and other departments in order to support release of short vein-to-vein products.

The Manufacturing Specialist reports to the Manufacturing Manager.

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