Project Leader - Drug Substance Biologics

20/06/22

Location

Industriepark-Zwijnaarde 7B, Ghent, Belgium

Vacancy

Eurofins CDMO wishes to strengthen its project management team with a Drug Substance Biologics 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.

Main responsibilities

  • The responsibility of the Project Leader is 'End-to-End' and concerns the development and/or manufacturing of 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. The team is composed of upstream and downstream scientists, formulators and analysts in charge of drug substance and/or drug product process development and analytical method development, as well as members from the production and quality departments (quality control and quality assurance) 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 a 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 in 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.

Qualifications

  • Preferably, a Master’s Degree with ten (10) years of experience or a PhD (in pharmaceutical science, bio-engineering, biotechnology, biochemistry) with five (5) years of experience.

  • Experience in project management is required, prior professional experience in a CDMO, biotech or pharmaceutical company is preferred.

  • Experience in biologics drug substance development, including upstream processes, downstream processes and analytics is required.

  • Knowledge of biological manufacturing processes (cell culture in bioreactors, E.coli or yeast fermentation, clarification, preparative chromatography, ultra- and diafiltration) and main analytical methods (sterility, bioburden, ELISA, analytical chromatography, SDS-PAGE, endotoxin, HCP, residual DNA, …) is required.

  • Experience in scale-up of manufacturing processes and technical transfer of projects is an asset.

  • Experience in drug product development in early phase is preferred.

  • 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 to 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, communicate appropriately, initiate problem-solving processes and propose remedial actions.

  • Fluent in English, written and spoken.

Additional Information

  • Work in a fast-growing organization.

  • A position with responsibility within a dynamic company.

  • Personal development through learning on the job and additional external training.

  • A market-oriented compensation.

Job application