Manufacturing Specialist, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

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, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

We are looking for a highly motivated Manufacturing Specialist EU to join our Manufacturing Point-of-Care Team in Leiden, The Netherlands.

Scope of the job

As Manufacturing Specialist, you provide operational expertise to our decentralized point-of-care manufacturing units for CAR-T cell therapies. You have a critical role in technical support through technology transfers and clinical manufacturing. You are an SME in aseptic training and passionate about your commitment to patients.

Your role

• Able to travel (on average 3 days/month) 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 first line technical support service for the decentralized point-of-care manufacturing sites (on average once every 7 weeks for a week), providing on-call 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. Contribute with technical training both, hands-on as well as documentation.

• Write and review technical electronic batch records, SOPs, protocols & reports.

• Closely collaborate with Quality Assurance, and other departments to support release of short vein-to-vein products.

This role reports to the Associate Director Manufacturing Point-of-Care Operations.