Description
We are searching for an expert microbiologist to join a project to oversee execution of microbiological concepts & strategies to guarantee compliance, sterility assurance and a state-of-the art microbiological quality for pharmaceutical drug products.Responsibilities:
Subject Matter Expertise (SME) for low endotoxin recovery (LER) analytical studies in the frame of the production of and sterile drug products.
As SME responsible for the validation and execution of LER studies on manufactured drug products. Evaluation of demasking methods and implementation of the validated demasking method into routine endotoxin testing of drug products to increase the microbial quality and sterility assurance. This needs a deep understanding of the biochemical properties of the endotoxin molecule.
Responsible for analytical, conceptual and strategic microbial projects relevant to his/her specific expertise.
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.
Ideal Background:
BSc. in Microbiology, Biology, Biotechnology or equivalent scientific degree.
Desirable MSc. or equivalent experience
Prior experience in microbiology as Subject Matter Expert
Michael Bailey International is acting as an Employment Business in relation to this vacancy.