(Senior) Process Engineer Manufacturing Process Transfer team, 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’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’.

For the Galapagos organisation in Leiden/NL, we arelooking for a (Senior) Process Engineer for the Manufacturing Process Transfer Team- EU

Scope

We are seeking a (Senior) Process engineer to join the Galapagos EU Manufacturing Process Transfer team providing technical-operational expertise to the GMP operations at decentralized manufacturing units (DMUs) in Europe. This Tech Transfer Lead is a subject matter expert on the manufacturing process during operations and Technology Transfer activities of automated CAR-T, helping to drive operations form site selection through clinical/pivotal/commercial readiness.

Your role

• Lead/support the Manufacturing team scope Tech Transfer activities through the stages of technology transfer.
• Lead/support technology transfers activities such as process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training and technical support
• Ensure the timely planning and execution of Tech Transfer activities in alignment with strategic planning and according to project timelines.
• Coordinate activities and continuous learning and improvement of each pillar of Tech Transfer.
• Triage operational challenges and deviations within the Tech Transfer process with internal stakeholders and DMUs to ensure compliance and qualification.
• Ensure consistency and control of the Tech Transfer processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports relating to clinical readiness and Tech Transfer.
• Perform data trending and analysis for Key Performance Indicators related to operational performance of Tech Transfers.

The position reports to the Lead/Associate Director EU Manufacturing Process Transfer and requires approximately 25% of travel.

• BSc/MSc in life sciences, biotechnology, engineering or related discipline.
• Experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development.
• Experienced in the coordination of Tech Transfer manufacturing activities.
• Experience of people/project management.
• Experience of management of quality records and documentation review and writing.
• Result-driven and can-do mindset, without compromising quality and compliance.
• Responsibility for own projects while pursuing company goals in open collaboration.
• Good interpersonal skills and written and spoken fluency in English.

What’s in it for you?

You will be part of a fast growing and amazing company. As a ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.

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