Job opportunity: Senior Scientist Upstream Processing Group
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 300 staff worldwide, we operate out of 6 sites either in France and Belgium. To support our ambitious
growth plan, we are today looking for a Senior Scientist Upstream Processing for our site in Ghent, Belgium.
Position: Senior Scientist Upstream Processing
Eurofins Amatsigroup wishes to enforce its Biological Drug Substance (DS) development and
production team with a Senior Scientist for the Upstream Processing department.
He/She will be part of a team responsible for conducting activities in the field of process development
and manufacturing of biologicals taking into account the regulatory requirements and clients’ needs.
The activities are related to cell culture and fermentation.
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 Team Leader Upstream Processing of the DS
His/her main responsibilities are:
- As a senior scientist and being a member of the Upstream Processing group, you will be
assigned to act as a lead scientist for one or more specific projects. This means review of
scientific work, setting up and rework of experimental plans based on gathered results from
project team and follow-up all upstream related activities. You will carry end responsibility
towards the quality of output, results, reports and methods.
- Develop microbial and mammalian cell culture processes including the harvesting procedure,
and perform scale-up studies
- Coordinate the transfer of the culture process to the cGMP facility
- Coordinate and perform production runs in a cGMP or non-cGMP environment in accordance
with the applicable requirements as described in procedures
- Ensure the follow-up of critical process parameters, monitoring of the process parameters
which may affect product quality
- Ensure Upstream process related SOPs, batch records and reports are set-up. Approve the
production related documents/batch records
- Internal and external communication of process results
- Follow-up new technologies in the field and support strategic decisions concerning future
- As senior scientist, you will be responsible over time for guiding one or multiple people in
function of his/her assigned projects and act as a scientific mentor.
Competences and education:
- A PhD (or a Master Degree with 5 years of experience) with biological scientific orientation
(Biochemistry, Bio-engineering, Industrial Engineering…) or related discipline with relevant
expertise (production of biologics)
- Knowledge about cGMP and current guidelines by regulatory instances is an asset
- You have a strong eye for detail (review of data)
- You are keen on being present in a laboratory/production environment
- Excellent organization and coordination skills
- Flexible and creative (problem solver)
- Excellent oral communication, reporting and presentation skills
- Ability to work independently as well as a member of a team in a dynamic environment
- Fluent in English and Dutch (written and spoken)
We offer you:
- A position with responsibility within a dynamic and growing company
- Personal development through learning on the job and internal/external trainings
- A market oriented compensation