Job opportunity: Project Leader – Drug Substance Biologics
Eurofins Amatsigroup is one of the leading CDMOs in Europe providing high-quality, customized drug
development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases
of their development pathway (from API to the clinical packaging).
Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development
package for new drug entities (biological and chemical) up to early clinical phases
to third parties to help them
in speeding up the development and manufacturing of their drugs:
- Drug substance biological process and analytical method development and production, including GMP
manufacturing. The principal technological expertise is production and purification of recombinant
proteins derived from microbial and eukaryotic systems, for research purposes and toxicological studies
as well as for clinical trials, including formulation development and stress stability studies. The company
also has extensive expertise in the manufacturing of viruses and living cells for vaccine purposes and indepth
knowledge of working under pharmaceutical and GMP quality requirements.
- Drug product development of new drug candidates focusing on difficult to formulate drugs that are in
preclinical, phase I or phase II clinical development. The company offers a full suite of drug development
services encompassing preclinical development, preformulation development, formulation
development, analytical development, dosage forms development, scaling-up and GMP manufacturing
of chemical and biologicals drug candidates.
Eurofins Amatsigroup NV develops and produces non-sterile and sterile biologicals (drug substance and drug
product) and chemicals (drug product) in preclinical and early clinical development phases.
With approximately 400 staff worldwide, we operate out of 7 sites either in France and Belgium. To support our
ambitious growth plan, we are today looking for a Project Leader for our site in Ghent, Belgium.
Position: Project Leader
Eurofins Amatsigroup NV wishes to enforce its team with a 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
- 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 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 cost (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 vendors and partners who participates to the
- The Project Leader assists business development by supplying technical input for the preparation of
- 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.
Competences and education
- Preferably, a Master’s Degree with ten (10) years of experience or a PhD (in pharmaceutical science,
bio-engineering, biotechnology, biochemistry or (analytical) chemistry) with five (5) years of experience.
- Knowledge of biological processes (cell culture / fermentation, column chromatography) and main
analytical methods (sterility, bioburden, ELISA, HPLC, SDS-PAGE, endotoxin, HCP, residual DNA, …).
- Experience in drug substance development, including upstream processes, downstream processes and
analytics is required.
- Experience in drug product development in early phase is preferred. Experience in scale up of
manufacturing processes and technical transfer of projects is an asset.
- Experience in GMP manufacturing, procedures and documentation, is an asset.
- Experience in project management.
- Excellent organization and coordination skills.
- Excellent oral communication, reporting and presentation skills, with demonstrated leadership in
providing integration of activities and delivering information across multifunctional groups and towards
- 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.
- We offer a varied and challenging job with a permanent contract combined with an attractive salary
- You will join a young, dynamic and experienced team of technologists, analysts and project leaders.
- Site: Eurofins Amatsigroup, Industriepark-Zwijnaarde 7B, 9052 Ghent, Belgium