Manufacturing Specialist US West Coast

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 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 our Clinical Manufacturing & Technology Transfer team, we are looking for a Manufacturing Specialist in the West Coast region, in the US.

Scope of the job

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

Your role

• 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.
• Ability to frequently travel to the decentralized 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, technical reports and deviations.
• Ability to relay industry standards regarding GxP, best practices in aseptic processing and cleanroom behavior.
• Closely collaborates with others within Manufacturing, Quality Assurance, and other departments in order to support release of short vein-to-vein products. Support implementation of change controls and CAPAs.
• Ability to share 24/7 technical support service for the decentralized 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.