Alexion Pharmaceuticals Development Scientist III, Product Characterization in New Haven, Connecticut

Position Summary

This position will lead biophysical characterization and oversee extensive product and impurity characterization and degradation pathway analysis for Alexion’s non-clinical, clinical and commercial stage products, utilizing mass spectrometry and other physicochemical methods. The candidate should have an established track record characterizing antibodies, proteins, peptides, and carbohydrates. The candidate is expected to be knowledgeable in all areas of chromatography, mass spectrometry, peptide sequencing, and binding kinetics and be able to utilize a broad array of other instrumentation. The candidate should have excellent team skills, effective organizational and presentation skills. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as 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 characterization, force degradation and comparability is a crucial requirement of this position.

Principal Responsibilities

  • Oversee, method development and preforming biophysical characterization of monoclonal antibodies and recombinant proteins by multiple techniques including: (60%)

  • Mass Spectrometry

  • Surface Plasmon Resonance

  • HPLC carbohydrate analysis

  • N-Terminal sequencing

  • AAA

  • SEC-MALS

  • CD

  • SDS-PAGE

  • IEF

  • 2D-PAGE

  • Enzyme digests

  • New technology evaluation (15%)

  • Authoring technical reports, department-specific protocols and general operating procedures (15%)

  • Managing associates (10%)

Qualifications

  • At least 7-10 years’ experience in antibody, protein, and peptide characterization and relevant assay development in pharmaceutical or biotech industry

  • 3 or more years of supervisory experience in an industry setting including associates and Ph.D.’s

  • Experience in product comparability assessment/evaluation and CMC documentation support.

  • Competence with MS Office programs, particularly Word, Excel and PowerPoint

  • Self-motivated, reliable team member

  • Ability to communicate effectively with senior management as well as with peers

  • Up-to-date knowledge of protein characterization methodologies

  • Excellent written and verbal communication skills

  • Ability to solve problems of scientifically challenging nature

  • Adherence to timelines

Education

  • PhD in chemistry, biochemistry, life sciences, or related discipline with a minimum of 7-10 years relevant work experience plus 3 years of management experience in the pharmaceutical/biotechnology industry is required.

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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.

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.