An opportunity has opened for an experience microbiology expert to join a 6 months project to advice on microbiological concepts & strategies to guarantee compliance, sterility assurance and a state-of-the art microbiological quality for pharmaceutical drug products.
Management of low endotoxin recovery (LER) analytical studies in the production of and sterile drug products.
Responsible for the validation and execution of LER studies on manufactured drug products.
Evaluation of test methods and implementation of the validated method into routine endotoxin testing of drug products to increase the microbial quality and sterility assurance.
Evaluation, validation and introduction of new microbiological test procedures incl. alternative methods.
Support the optimization and validation of analytical methods and equipment as well as cooperation on pharmacopoeial issues.
Preparation and introduction of necessary SOP’s.
Support method transfers from and to the laboratory.
BSc. in Microbiology, Biology, Biotechnology or equivalent scientific degree.
Prior experience in sterile drug product management and microbiology
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.