Alexion Pharmaceuticals Inc Development Scientist II, Early Assay Development in New Haven, Connecticut

Alexion Pharmaceuticals, Inc.Alexion is an Equal Opportunity/Affirmative Action Employer.Req ID: 5222Job Category: Process DevelopmentLocation: New Haven , CTPosting Date: May 16, 2017Position Summary This position will develop, oversee, and or perform test method for biotherapeutics in the area of mass spectrometry and surface plasmon resonance (SPR). This position reports directly to the Director of Early Assay Development, is expected to work independently, and oversees scientist and associates in the lab. The candidate should have an established track record characterizing antibodies, proteins, and peptides. This position will be utilizing mass spectrometry, HPLC, UPLC, SPR as the major characterization methodology. However, the candidate is expected to be knowledgeable in a broad array of other characterization techniques. The candidate should have excellent team, effective organizational, writing and presentation skills. In addition, this position is expected to interact regularly with scientific staff in other Research and 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.Principal ResponsibilitiesExperimental characterization, testing and method development for monoclonal antibodies and recombinant proteins. (50%)Participating in general laboratory operations including equipment maintenance and organization (10%)New technology evaluation and manage the activities of the external research laboratories (10%)Authoring CMC sections for regulatory, technical reports, department-specific protocols and general operating procedures (20%)Managing team members and playing a key role on cross-functional teams (10%)QualificationsPosition requires in-depth knowledge of general test methods for testing protein therapeutics including monoclonal antibodies and glycoproteins.The candidate must be familiar with the regulatory guidelines that are related to testing biotherapeutics and the validation of test methods.An ideal candidate has been involved with assay development, optimization, and qualification for protein therapeutics.Position requires an overall understanding of instrumentation associated with the protein assays pertaining to biopharmaceuticals.Knowledge of method development using mass spectrometry, surface plasmon resonance, and other characterization techniques, is essential.Ability to take initiative in problem solving.Ability to consistently bring independent, scientific approach to method development.A thorough understanding of GLP and quality guidelines is expected for a successful candidate.The individual must be able to give clear instructions and to train personal as required on practices within the laboratory. Planning and organizing skills are required to plan, execute and track commitments of the laboratory and to adjust to changing priorities.Excellent interpersonal skills are required, as is the strong ability to communicate effectively.Education Ph.D. in a scientific discipline (Biochemistry, Analytical or Biological Sciences), with at least 5 years of relevant assay development experience in the pharmaceutical/biotechnology industries.*LI-DD1New Haven, CT, United StatesAlexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in