Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 35 countries for the treatment of PNH, and in the United States for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
This position is required to perform test method development and optimization for biotherapeutics. The position will also lead validation, implementation, and transfer of methods to QC. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to test methods is a crucial requirement of this position.
• Develop, optimize, and validate test methods for therapeutic proteins (55%)
• Author technical reports for the development and implementation of test methods. Draft reports for regulatory filing (10%)
• Perform transfer of test methods for release and stability to QC (10%)
• Provide assay support to research efforts; conduct assay transfer from other R&D groups (10%)
• Participate in cross-functional process development teams representing Analytical Sciences (5%)
• Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations (5%)
• Present results in internal meetings (5%)
BioSpace.com - 2 years ago
Alexion Pharmaceuticals, Inc. (Alexion) is a biopharmaceutical company engaged in the discovery, development and delivery of biologic...