The position is required to join Pharmaceutical Development group of Alexion pharmaceuticals' Analytical and Pharmaceutical Development department. This position is required to conduct studies to enable pharmaceutical support of Alexion early and late stage drug candidates, with the emphasis being on the frozen drug substance process development and implementation support for drug product products at high protein concentration, as well as commercial products (various testing to support Drug Product development, licensing and manufacturing). The ability to work independently as well as part of the team is essential. The position entails execution of the studies and data processing and compiling to support development reports as well as other required documentation. Solid understanding of solution chemistry is highly preferred. Hands-on experience with modern analytical instrumentation is required. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as groups within Analytical Sciences and Pharmaceutical Development (APD), Biologics Process Development (BPD), Technical Services, Global Supply Chain, Manufacturing, Quality Assurance and Quality Control.
Understanding of the basic principles of protein chemistry, protein fold stability, biotherapeutics formulation development, as well as drug product development and manufacturing would be a plus.
Position requires scientific and practical knowledge of protein chemistry, where familiarity with chemical and biophysical assays in biotherapeutics drug development would be a plus.
Previous experience in biotherapeutics liquid formulation development as well as understanding of the biothechnology products life cycle and factors impacting protein molecule stability is preferred.
Experience with biotherapeutics drug product development and manufacturing is a significant plus.
Hands-on experience with instrumentation, used in protein pharmaceutical and analytical development as well as characterization is preferred.
Ability to take initiative in problem solving.
Knowledge of cGMP and quality guidelines would be desirable.
The individual must be able to work in a collaborative setting.
Ability to adhere to timelines is essential.
Excellent interpersonal skills are required, as is the strong ability to communicate effectively.
New Haven, CT, United States
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 and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 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) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. 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, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.