Manufacturing Specialist US

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’.

For the Point of Care (PoC) Manufacturing team, we are looking for a Manufacturing Specialist in the East Coast region, in the US.

Scope of the job

Galapagos' Cell Therapy group is located in Leiden, The Netherlands. For our USA expansion, we seek a Manufacturing Specialist to join the PoC Manufacturing organization, while based in the United States. As Manufacturing Specialist, you have a critical role in technical support through technology transfers and clinical manufacturing, are an SME in aseptic training and have a strong commitment to patients.

Your role

• Ability to frequently travel to the decentralized Point-of-Care Manufacturing Units, to support operational readiness activities including but not limited to, production training, aseptic operator qualifications and process validations.
• Ability to use technical writing to write and review training material, electronic batch records, SOPs.
• Ability to relay industry standards regarding GxP, best practices in aseptic processing and cleanroom behavior.
• Closely collaborates with others within PoC Manufacturing, PoC Quality Assurance, and other departments in order to support release of short vein-to-vein products.
• Ability to share 24/7 technical support service for the decentralized Point-of-Care Manufacturing Units.
• Providing front-line troubleshooting, coordination of subject matter experts and deviation management to ensure timely release of CAR-T products that meet quality/regulatory requirements.