The Clinical Release and Stability (CRS) group is a department within Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD).
- Development and GMP qualification/validation of microbiology methods (Microbial Purity, Bacterial endotoxin, Sterility, etc.)
- Microbiological testing for screening, CTA/IND, MAA/NDA stability studies and release testing of clinical batches
- Development and GMP qualification/validation of microbiology methods according Pharmacopeial requirements and company procedures;
- Microbiological testing for screening, CTA/IND, MAA/NDA stability studies and release testing of clinical batches;
- Monocyte Activation Tests (MAT);
- Low Endotoxin Recovery (LER) studies;
- ID dot blot testing of Large Molecules.
- You hold a bachelor degree in Biomedical Laboratory Technology, or equivalent through experience;
- At a minimum, 2 years of hands-on experience in a pharmaceutical microbiology laboratory (GMP);
- Good knowledge of microbiological aspects in (bio)pharmaceutical processes and products, both sterile and non-sterile;
- Ensure high quality of work and take full responsibility;
- Efficient, flexible, dynamic;
- Customer-focused and result driven;
- You have a good knowledge of English, both spoken and written;
- You are able to work independently, though you are also a team player.
- As an employee we consider you as our most valuable asset. We take your career seriously.
- As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
- Through e-university, on the job training, various projects and programs, we ensure your personal growth.
- Our benefits make sure we care for you and your family now and in the future.