2 Manufacturing Specialists - Contractor (6 months), Leiden

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

Scope of the role:

We are seeking Manufacturing Specialists to provide operational expertise to our decentralized  manufacturing units for CAR-T cell therapies.  The candidate will have a critical role in technical support through clinical manufacturing and technology transfers, act as SME in aseptic training, facilitate production training and take ownership of material management. Furthermore, a strong commitment to patients is paramount.

Responsibilities:

• Support GMP activities at the decentralized point-of-care manufacturing sites as part of tech transfers and clinical manufacturing, including equipment qualification, production training, aseptic process validation, process qualification runs, 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 meeting quality/regulatory requirements.
• Closely collaborates with Quality Assurance, and other departments in order to support release of short vein-to-vein products. Support implementation of change controls and CAPA.
• Ability to relay technical information and mentor peers. Contribute with technical training both, hands-on as well as documentation.
• Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports.