Project Leader - Drug Product
Project Leader - Drug Product
Industriepark-Zwijnaarde 7B, Ghent, Belgium
Eurofins CDMO wishes to strengthen its project management team with a Drug Product Project Leader and is looking for a professional with expertise in the biotech sector. This position will report to the Director Project Management of Eurofins Amatsigroup NV, Ghent, Belgium.
The responsibility of the Project Leader is 'End-to-End' and concerns the development and/or manufacturing of drug product for small molecules and biologics, either within Eurofins Amatsigroup NV or at external partners.
The Project Leader leads a cross-functional team of scientific experts who covers the entire service portfolio of Eurofins Amatsigroup NV. Depending on the nature of the projects, the project team can be composed of formulators and analysts in charge of drug product and analytical method development, as well as members from the production and quality departments who support GMP manufacturing activities.
The Project Leader manages the project development plans, including timelines and resources, while managing and balancing customer expectations (timing and quality) and project financials (invoicing, costs and resources).
The Project Leader acts as single point of contact for the client. He/She centralizes all communication to and from the client and also interacts with external partners who participate to the projects, including sterile manufacturing sites within the Eurofins CDMO group.
The Project Leader assists business development by supplying technical input for the preparation of proposals.
The Project Leader manages the planning and execution of the project deliverables and coordinates project transfer along the project continuum. He/She optimizes the Eurofins Amatsigroup development methodologies, making use of and improving standard technology platforms, accelerates development timelines, and coordinates all dossier writing activities (IMPD).
This position is based in Ghent, Belgium. Limited international travel can be required.
Preferably, a Master’s Degree with five (5) years of experience or a Ph.D. (in pharmaceutical sciences, or (analytical) chemistry).
Experience in project management is required, prior professional experience in a CDMO, biotech or pharmaceutical company is an asset.
Experience in drug product development is required, including early phase development, scale up of manufacturing processes and technical transfer of projects to third parties.
Experience in GMP manufacturing, procedures and documentation is an asset.
Excellent skills in organization, coordination, communication (oral and written), reporting and presentation, with demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and towards the customer.
Able to work independently as well as a member of a team in a dynamic and fast-paced environment.
Able to identify problematic situations, to communicate appropriately, to initiate problem solving processes and to propose remedial actions.
Fluent in English, written and spoken.
Work in a fast growing organization.
A position with responsibility within a dynamic company.
Personal development through learning on the job and additional external trainings.
A market oriented compensation.