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 biologics drug candidates.
Eurofins Amatsigroup NV develops and produces non-sterile and sterile biologics (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 Head of Biologics Drug Product for our site in Ghent, Belgium.
Eurofins Amatsigroup wishes to enforce its team with a Drug Product Biologics Development Manager and is looking for a professional with expertise in the biotech sector.
We are looking for a person that reports to the CSO of Eurofins Amatsigroup NV in expanding the growth of the company by further building the Biologics Drug Product group.
His/her main responsibilities are:
- You are responsible for R&D drug product development of biologics (formulation & analytics).
- Leading a group of scientists focusing on biologics.
- Scientific leadership in formulation of biologics for a broad type of molecules and formulation types (solid and liquid).
- Development and follow up of pharmaceutical and chemical analyses using different techniques.
- Implementing new analytical methods & techniques focusing on biologics.
- Assignment of resources to current projects.
- You support Business Development with your technical expertise and planning.
Competences and education:
- A PhD in science (Pharmaceutical Sciences, Biochemistry, Bio-engineering).
- You have at least 5 years of experience with the formulation of biologics (proteins (antibodies, enzymes, growth factors, ..), oligonucleotides or peptides).
- You have a strong interest in drug research and development and the associated production technologies.
- You have experience with analytical techniques and method development for biologics (HPLC, UV/IR/Fluorescence spectroscopy, DLS, DSC, cIEF, ELISA, etc.).
- Knowledge on design and evaluation of stability studies.
- Awareness of the ICH-guidelines concerning stability indicating methods
- Knowledge on spray drying or lyophilisation development is an asset.
- Experience with people management and leading a team of experts.
- Excellent organization, flexible and coordination skills.
- Excellent oral communication, reporting and presentation skills.
- Ability to work independently as well as a member of a team in a dynamic environment.
- You are fluent in English and/or Dutch.
We offer you:
- A position with responsibility within a dynamic company
- Personal development through learning on the job and additional external trainings
- A market oriented compensation
Interested in this challenging job?
Please send your application including CV and motivation letter via e-mail to Alexandrine Abbeloos (firstname.lastname@example.org) and you will be contacted soon.