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 Senior Team Leader for our biological purification group for our site in Ghent, Belgium.
Eurofins Amatsigroup wishes to enforce its biological purification team with a Downstream Process Manager and is looking for a professional with a strong background in manufacturing (recombinant) proteins for medical applications. Experience in the biotech sector and with the purification and (GMP) manufacturing of proteins is essential.
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 Director of DS Biologicals.
His/her main responsibilities are:
- Establish and lead the downstream group within the Biological Drug Substance Unit with process and operations-based expertise to support timely delivery (within the budget) of developed purification processes and of clinical batches of purified recombinant proteins
- Be responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for GMP production
- Preparation and revision of downstream purification batch records and reports
- Lead initiatives to ensure continuous improvement of the tools and technologies that are used for downstream processing in our company
- Lead initiatives to ensure optimal planning and communication to the appropriate stake-holders and project managers
- Mentor junior scientists or associates, providing scientific and technical expertise and guidance on downstream processing
- Effectively presents results at internal meetings and external meetings (scientific and with clients)
- Represent the downstream group at regulatory inspections and respond to questions
Competences and education:
- A PhD or a Master Degree with scientific orientation (Pharmaceutical sciences, Chemistry, Biochemistry, Bio-engineering, Industrial Engineering) or related discipline with relevant expertise, e.g. downstream processing of recombinant proteins on a microbial and/or mammalian platform
- Experience in technology transfer, purification process development and transfer to GMP
- Experience for lab scale to large scale manufacturing
- Knowledge on process characterization and validation
- Should have knowledge on cGMP and quality system
- Ability to proactively address process related issues
- 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
- Skilled in training, coaching, leading people
- Fluent in English and Dutch, written and spoken. Knowledge of French or German is an advantage.
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.