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Project Leader – Biologics

Job opportunity: Project Leader - 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 in-depth 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 10 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

Position/Responsibilities Eurofins Amatsigroup wishes to enforce its team with a Project Leader and is looking for a professional

with expertise in the biotech sector and/or experience in business development. We are looking for a person that reports to the Director Project Management of Eurofins Amatsigroup NV.

His/her main responsibilities are:

• 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 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.

• 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 projects.

• 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.

Competences and education:

• A Master’s Degree with ten (10) years of experience or a PhD (in pharmaceutical science, bioengineering or (analytical) chemistry) with five (5) years of experience.

• Demonstrated competency and experience in drug product development within the pharmaceutical industry.

• Experience in large molecule or biological-based drug product development and technology transfer is required.

• Demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and towards the customer

• Drug product development experience in early phase is preferred. Experience in scale up of manufacturing processes and technical transfer of projects is an asset.

We offer you:

• We offer a varied and challenging job with a permanent contract combined with an attractive salary package.

• You will join a young, dynamic and experienced team of technologists, analysts and project leaders.

• Site: Technologiepark, Zwijnaarde - Ghent, Belgium

Thank you for applying for a career at Amatsigroup
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Thank you for applying for a career at Amatsigroup
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