The Regulatory Lead is the regulatory scientific expert and a standing member of assigned compound development project teams. In this role, the Regulatory Lead delivers the regulatory strategy and executes this strategy upon endorsement by the project team, in an effective and compliant manner throughout all phases of development.
The Regulatory Associate CMC is responsible for managing the day-to-day support activities to obtain and maintain regulatory approvals for Galapagos’ products, with primary focus on CMC submissions. The Regulatory Associate CMC is the primary regulatory liaison with the CMC department and a standing member of the CMC subteam.
The Regulatory Associate Document Management is responsible for managing and organising the day-to-day regulatory documentation and compliance activities. This function is the business owner and primary contact for the Galapagos’ Development Group document management system (PLAZA).
The regulatory operations function is responsible for the day-to-day operational support to the regulatory affairs department, to obtain and maintain regulatory approvals for Galapagos’ products.
You will work within a team that develops and runs biochemical, cellular and phenotypic assays in support of our drug discovery programs at Galapagos. The position holds a mix of practical lab work on the one hand, and coordination of outsourcing of in vitro biology activities on the other hand.
You will be part of a team that develops and runs biochemical and cellular assays for target-based pharmacological and phenotypic characterization of small synthetic molecules and antibodies from our drug discovery programs. On top of practical lab work, you will be involved in analysis and reporting of experimental results within the team.
As a Senior Quality Monitoring Lead for Development, you will be responsible for implementing the “pro-active quality principles” throughout the Development organization (i.e. CMC, Pre-Clinical Safety, Clinical Development Partners, etc....) by providing continuous support and input during the project team meetings and respective sub team meetings.
As a Senior Quality Monitoring Lead for Research, you will be responsible for implementing the “pro-active quality principles” throughout the Research organization (i.e. from Target Discovery through Pre-Clinical Candidate Declaration) by providing continuous support and input during the project team meetings and respective sub team meetings.
The “Senior Therapeutic Area Lead” will be responsible for leading a set of projects in the auto-immune and / or fibrosis portfolio from target discovery stage up to pre-clinical candidate delivery. He / she will play a critical role in setting the strategy that Galapagos will pursue in the area.
Drug Substance Development (Sr) Lead - MEC-194
As Lead drug substance development CMC, you will be responsible for the drug substance (API) development and up-scaling strategy and execution thereof for various development projects.
Je zal deel uitmaken van de medicinale chemie groep ter ondersteuning van de drug discovery projecten van Galapagos.
You will be responsible for managing the day-to-day administrative support activities for the entire Development group (Mechelen and Romainville).
As Lead Clinical Supply, you will be responsible for managing clinical supply chains for clinical studies involving Investigational Medicinal Product (IMP), active comparators and matching placebo to ensure uninterrupted drug supply throughout the clinical study at sites worldwide.
The core purpose of the job is to manage the drug product development and clinical bulk supplies for various development projects.
There are currently no openings.
Within the Molecular Modelling and Design group, you will design a combinatorial library around a new chemical scaffold to target protein kinases. The available building blocks will be first filtered to remove undesirable chemical moieties using in-house tools. An additional task will involve further improving the current tools that flag such undesirable moieties by annotating the existing alerts.
Depending on the candidate prior experience, technical competencies that will be acquired might include the use of industry-standard software such as PipelinePilot and Maestro as well as literature scouting
You will support the Development team in contributing to the characterization of preclinical ADME profile of new drug candidates.
In particular, you will:
Within the Clinical Pharmacology group, you will provide quantitative pharmacokinetic (PK) and pharmacodynamic (PD) modelling and simulation expertise to Galapagos projects to understand the Clinical Pharmacokinetics and Pharmacodynamics of novel drug candidates.
Your principal accountabilities will be:
You will report to the Clinical Pharmacology Head and work in close collaboration with statisticians and physicians from the Clinical development group
This position gives you the opportunity to join the team implementing our biobank over 3 sites in Europe. Under the authority of the Project leader, you will manage the scientific, regulatory, administrative and organisationnal scopes of the project in an exciting and dynamic environment of a well-known successful international biotech company. The biobank is centralizing a large diversity of animal and human samples from research and clinical studies
Within the Development department, the Senior Scientist Scale-up is responsible for the route optimization and manufacturing of the first preclinical batch of API. The core purpose of the job is to ensure quality and timely delivery of the preclinical batch.
Within the Development department, the Laboratory Technician Scale-up is responsible for managing the day-to-day support activities in the scale-up laboratory. He/She will execute the route optimization and the manufacturing of the first preclinical batch of API. Fixed-term contract of 6 months