BrightOwl Loader Loading

Research Associate - Belgium  

Company managed [?] Still accepting applications
42 Facebook  Linkedin

Posted on : 15 April 2017

Project Description


Description:
The Clinical Release and Stability (CRS) group is a department within Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD). 
Amongst other activities, the PDMS Micro team is responsible for:
  • 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


Your Function
Under supervision of the laboratory supervisor and a microbiology subject matter expert, you are responsible for the execution of:
  • 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.




Qualifications
  • 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.



Our Offer:
  • 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.