Regional Head Of Manufacturing - US, Princeton, Nj/Us

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

We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. 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 Regional Head of Manufacturing - US

The Regional Head of Manufacturing for the US, builds and leads a team of Manufacturing Managers, Engineers and Technicians responsible for regional GMP operations, including clinical manufacturing, technology transfers, training and material management. The role aligns vision and values by creating effective feedback loops in partnership with several global and regional teams. Your operational and strategic leadership is key to co-drive our expanding global network of decentralized manufacturing units for CAR-T cell therapy.

Your role

• Lead the rapidly growing CAR-T manufacturing operations at the decentralized manufacturing sites in the US, ensuring short vein-to-vein timelines to the patients and expansion of the manufacturing network.

• Oversee day-to-day clinical manufacturing activities at the decentralized sites, ensuring consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform.

• Lead execution of technology transfer activities at the decentralized manufacturing sites, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.

• Lead a 24/7 global front-line support service for the decentralized manufacturing sites, providing troubleshooting, deviation management, escalation, process/product impact assessments, root-cause investigations for deviations, coordination of subject matter experts to ensure timely release of CAR-T products meeting quality/regulatory requirements.

• Lead preparation of GMP material kits in a cleanroom environment facility, ensuring timely material supply to the sites.

• Lead Aseptic Process Validation (APV) and Aseptic Operator Qualification (AOQ) planning and execution. Lead production training, providing onsite and remote training to production personnel at the decentralized sites.

• Lead and determine corrective actions and support implementation of change controls.

• Support elaboration of electronic batch records, SOPs, protocols, risk assessments, position papers, root-cause investigations for deviations, determine corrective actions and support implementation of change controls.

• Budget Management:

• Take responsibility for managing the budget for Manufacturing in the region, including the cost of labor, equipment, and supplies.

• Develop and oversee the budgeting process, ensuring alignment with business goals and objectives.

• Monitor and track expenses, identify areas for cost savings, and implement measures to optimize spending.

The Regional Head of Manufacturing for the US is based in Princeton, NJ, reports to the US Regional Head of Technical Operations and is part of the Regional Technical Operations Leadership Team.

• BSc/MSc degree in life sciences, biotechnology, engineering or related discipline.

• 10+ years' experience, including extensive people management experience.

• Experience with management of contract manufacturing organizations.

• Experience with GMP manufacturing, technology transfers, process validation, cell & gene therapy processes, automated bioreactors, regulatory inspections.

• Excellent problem-solving skills.

• Ability to effectively manage multiple projects and priorities in a fast-paced environment.

• Demonstrated experience leading cross-functional teams and managing projects from conception to completion, with a focus on quality, compliance, and timelines.

• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels of the organization.

• Ability to be flexible with changing priorities.

• Result-driven and can-do mindset, without compromising quality and compliance.

What's in it for you?

You will be part of a fast growing and amazing company. As 'make-it-happener' you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos' leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen…!