– Tracking ongoing drug substance and drug product manufacturing activities at CMOs using the CMOs information data points.
– Track QC data for batch release of DS & DP batches
+ CMO QC data
+ Alexion QC data
– Populate Alexion databases & data repositories with the required information/data from CMOs and internal sources
+ Maintain the technical services data repository and lead phase 2/3 of the project to create a data repository
+ -Learn the requirements of good manufacturing practice.
+ Learn about the drug substance manufacturing processes at CMOs & in our BDS plant.
+ Learn about the drug product manufacturing processes.
+ Gain an understanding of the multiple functions required to supply a biological treatment to patients.
Manage non-routine sampling from CMOs:
+ Track samples to ensure they are taken and shipped
+ Supply notification to the receiving laboratory
+ Supply testing related paperwork/documents
+ Track testing timelines and data output (data should feedback into the TS data repository to be available to all for review)
+ A B.Sc. or equivalent, either completed or a student in Biotechnology, Biological Sciences, Biochemistry, Bioengineering or a similar scientific discipline with 0-2 years’ experience, or an equivalent combination of education and experience.
+ Time Management
+ Communication Skills
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.