Development Scientist I, Analytical Sciences

  • Alexion Pharmaceuticals, Inc.
  • New Haven, CT
  • Mar 18, 2019

Job Description

Alexion Pharmaceuticals, Inc.

Alexion is an Equal Opportunity/Affirmative Action Employer.

Req ID: 15484
Job Category: Process Development
Location: New Haven, CT
Posting Date: March 16, 2019

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Position Summary

This position is required to perform analytical method development and optimization for clinical and commercial biotherapeutics. This position will also support characterization and investigation efforts, and conduct testing for Alexion's biotherapeutic products when required. Participation in method validation and transfer of methods to internal and external laboratories may be required. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. The Scientist I is also expected to train and mentor other lab personnel as assigned in areas of expertise. 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 Responsibilities
  1. Develop and optimize test methods for clinical and commercial therapeutic proteins, e.g HPLC, CE (including LoC and iCE), and ELISA
  2. Author SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing
  3. Work with Analytical Technical Transfer Services (ATTS) to develop and execute validation protocols
  4. Provide support to ATTS during and post method transfer (e.g. training, troubleshooting) as needed
  5. Perform testing for in-process, drug substance and drug product release and stability samples if needed
  6. Participate in cross-functional process development teams representing Analytical Sciences
  7. Maintain knowledge of current scientific principles and theories. Train and mentor other lab personnel as assigned in areas of expertise
  8. Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations
  9. Organize activities of self and others as required to achieve project objectives
  10. Present results in internal and external meetings

  • Five to eight years of relevant work experience with advanced degree in the pharmaceutical or biotech industry.
  • Position requires scientific and practical knowledge of general test methods for analyzing protein therapeutics including monoclonal antibodies and glycoproteins.
  • Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus.
  • Position requires an overall understanding of instrumentation associated with the protein assays pertaining to biopharmaceuticals.
  • Knowledge of method development using HPLC, electrophoresis, and ELISA is essential.
  • Ability to take initiative in problem solving.
  • Ability to consistently bring independent, scientific approach to method development.
  • Knowledge of cGMP and quality guidelines is desired.
  • 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

  • Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline
  • Experience in analyzing and characterizing proteins in an academic setting is desired

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 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:

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.

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