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.
Position: Scientist biochemical analysis
Eurofins Amatsigroup wishes to enforce its Biological Drug Substance (DS) development and production team with a Scientist for the Quality Control department.
He/She will be part of a team responsible for conducting activities in the field of the quality control of products derived from process development and manufacturing of biologicals taking into account the regulatory requirements and clients’ needs. The activities are related to analytical method development, qualification and testing.
We are looking for a person that collaborates with the Eurofins Amatsigroup team in expanding the growth of the company. He/she will report to the QC manager of the DS Biologicals team.
His/her main responsibilities are:
• Develop, qualify and validate the analytical methods required to analyze the biological products
• Perform analytical tests in a cGMP or non-GMP environment according to the applicable requirements as described in the Q-Biologicals procedures
• Assist in the creation and maintenance of laboratory SOP
• Assist in writing of records for the testing documentation of the product (cGMP and non- GMP)
• Troubleshoot lab methods and instruments
• Document the work performed in lab note books and/or in QC records
• Assist in writing the development, qualification and validation reports, and the test descriptions
• Participate in activities to support the function of the team
• Assist in laboratory investigations
Competences and education:
• An industrial master degree or a scientific master degree preferably in life science, chemistry or pharmacy or other related degree
• At least 2 years working experience in a biotech, pharmaceutical or biopharmaceutical environment
• Knowledge of analytical methods for protein analysis, including UV spectroscopy, SDS-PAGE electrophoresis, western blotting, ELISA, potency testings…
• Knowledge of microbiology: CFU count, purity analysis, Gram staining, plasmid retention,…
• Enthusiastic, pro-active, analytical, open-minded, curious, self-motivated and hands-on approach.
• Flexible attitude
• Sense for initiative, quality, accuracy and detail
• Be a good communicator within the team
• Having the skills to present own results in the team meetings
• Ability to evaluate performed activities and be able to think about and suggest changes/improvements
• Ability to work independently as well as a member of a team in a dynamic environment
• Ability to plan own activities based on weekly input from the Team Leader/Project Manager
• Fluent in Dutch and English, written and spoken
We offer you:
• A position with the possibility of personal growth within a dynamic and growing company
• Personal development through learning on the job and through internal and external trainings
• A market oriented compensation and benefit plan