Process Engineer Tech Transfers - Contractor (6 months), Leiden

Pleased to meet you, we are Galapagos , a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

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.

For our Cell Therapy organization in Leiden, we are looking for Process Engineer Tech Transfers.

Scope of the role:

We are seeking a (Sr) Process engineer to join the Galapagos EU Manufacturing Process Transfer team providing technical-operational expertise to the GMP operations at decentralized point-of-care manufacturing units in Europe. The 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.

Responsibilities:

• Lead/support the Decentralized Manufacturing Unit (DMU) 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 DMU’s 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.

Who are you?

• 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?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.