Principal Scientist Non-clinical Cell Therapy, temporary contract (7 months), 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’.

We are looking for a temporary Principal Scientist Non-clinical Cell Therapy (maternity leave replacement from 15/10/24-15/05/25), Leiden/NL

Scope of the job

With our innovative cell therapy (e.g. CAR-T), which is a decentralized manufacturing model at the point-of-care, we passionately work on the potential for patients to offer efficient treatments avoiding complex logistics and resulting in potential better patient outcomes and broader access.

As Principal Scientist Non-clinical Cell Therapy you set up and execute non-clinical studies for all development phases related to cell therapy in this model. You write study plans and protocols for in vivo and in vitro efficacy/safety studies to be executed in-house or with outsourcing partners. To align on study planning and execution, your coordinate with other teams and departments within Galapagos. Furthermore, you plan shipments and transfer protocols that are required by outsourcing partners and, with a strong eye for detail, review study data and take responsibility for documentation of study results for CTA/IND filing.

Your role

• Design and execution of in-house preclinical studies in line with company strategy, documented in study plans.
• Outsource, design, initiate, analyse the results and monitor the progress of in vitro and/or in vivo studies, on animal models or materials, for the cell therapy in agreement with the relevant guidelines and (ICH, EMA, FDA) strategic decisions and timelines of the PT.
• Coordinate with internal departments to properly execute studies (e.g. CMC for cell-based or in vivo studies following in-house automated manufacturing (Cocoon ®) runs).
• Discuss with the line manager and other team members to have sound strategies and accurate updates on the project, to flag any issue/point of concern raised along the PCD programme and to identify different options to address them, with respect to regulatory requirements as well as project objectives and timelines.
• Supervise and coach Technicians and Scientists.
• Critically review study data and responsible for the full documentation of all study results for CTA/IND filing. Write and/or review nonclinical modules and study reports.
• Prepare internal reports and presentations.
• Remain up to date with Company strategy, milestones and objectives.
• Remain up-to-date with relevant literature, technology and industry developments, attend conferences, discuss developments with management.
• Adhere to existing Policies and Procedures and ensure timely completion of relevant training.
• Perform scientific assessment of new and existing vendors.

This role reports to the Director of Non-Clinical Cell Therapy and interacts with many different colleagues, from QA, CMC, AD, QC, to name a few.

• Master of PhD degree in Life Science
• 5 years or more post qualification experience
• Proficient use of MS office applications
• Knowledgeable about GLP
• Proficient in English
• Driven to cure patients

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…!