The Analytical Development Department is responsible for the design, development, qualification/validation, and transfer of analytical test methods as well as implementing analytical controls that enable pharmaceutical products to meet the required quality and safety standards. The team routinely reviews and updates the test methods based on the most up to date regulatory requirements. Horseshoe crab derived LAL reagent has been historically the gold standard for bacterial endotoxin testing (BET) in pharmaceutical products. However, due to its environmental impact, European regulators are increasingly recommending sustainable, environmental-friendly alternative reagents. How You Will Contribute: Method development study planning and execution. Gain hands-on experience in establishment of endotoxin test method using recombinant Factor C Assist in various tasks, including study design, data collection, data analysis, and troubleshooting as needed Collaborate with cross-functional teams, communication and presentation of the project outcome. Internship Development Opportunities: Interns will learn: The intern will gain comprehensive understanding of bacterial endotoxin test principles and hands-on experience with endotoxin assays for protein-based pharmaceutical products. Planning and execution of the experiments, troubleshooting problems as well as collaborating with other members of Analytical Development.
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Job Type
Full-time
Career Level
Intern
Number of Employees
5,001-10,000 employees