Alexion is a global biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialisation of life-transforming therapeutic products. Alexion developed and markets a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two severe and life-threatening ultra-rare diseases. Alexion is developing other highly innovative product candidates which are being investigated across multiple severe and ultra-rare disorders. Alexion has been recognized as the second most innovative company in the world by Forbes magazine two years in a row (2012 and 2013). Today, Alexion has more than 1,800 employees with operations to serve patients in more than 50 countries.
Ireland is the base for Alexion’s Global Supply Chain and Operations and is a key part of the on-going expansion in the company’s global organisation. The company currently has offices in Dublin and is developing two additional facilities. The first is in Athlone and will house a state of the art aseptic fill finish facility which will be operational by mid 2015. Additionally, laboratory facilities for Chemistry and Microbiology are also being constructed on this site. The company has also recently invested in another site in College Park which will become a Centre of Excellence for Global Operations and is scheduled to be operational in 2016. The company’s expanding Irish workforce is expected to manage the supply of existing and new Alexion therapies to patients following regulatory approvals for a series of anticipated launches over the next several years.
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The Cell Culture (Upstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin.
The QC Microbiology Supervisor will support the QC department with emphasis on QC Microbiology. The supervisor will provide technical support with regard to method verification, Environmental Monitoring, Utilities and new technology.
The Director-Enterprise Quality-Program Management and Continuous Improvement has a global focus within Enterprise Quality owning the implementation and continuous improvement of the Quality Management System (QMS).
The Associate Director-Enterprise Quality-Risk and Exception Management has a global focus within Enterprise Quality ensuring a consistent approach to management of Deviations, CAPA, Change Control, and Quality Risks across all GXP functions.