BrightOwl Loader Loading

Development Scientist I, Pharmaceutical Development - United States  

Alexion (company)

Posted on : 13 May 2017

Project Description



Position Summary

This position is required to plan and execute studies towards formulation development for preclinical and clinical stage molecules.  The incumbent will also serve in the capacity of extractables/leachables subject matter expert across Alexion’s commercial, clinical and preclinical stage products. The position is also required to plan and execute studies to support clinical materials compatibility and dosing solution stability. The position will manage stability studies for clinical development candidates.  The position will include analytical method development and optimization for biotherapeutics.  In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as groups within Global Analytical Sciences and Pharmaceutical Development (GAPD), Biologics Process Development (BPD), Technical Services, Global Supply Chain, Manufacturing, Quality Assurance and Quality Control.  The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to formulation development, extractables/leachables, stability and test methods is a crucial requirement of this position.


Principal Responsibilities

  • Design and execute pre-formulation screening and formulation development studies for preclinical and clinical stage biopharmaceuticals (20%)
  • Design and execute extractable and leachable studies for commercial and clinical biopharmaceuticals.  Provide support for extractable and leachable assessments for container-closure systems and process contact materials (20%)
  • Design and execute clinical material compatibility and dosing solution stability studies for clinical product candidates. (20%)
  • Author technical reports for the development, implementation of test methods, support submissions for IND and draft reports for regulatory filing (10%)
  • Manage stability studies for clinical development candidates. (5%)
  • Analyze and interpret analytical data. (5%)
  • Support technical transfer and validation activities (5%)
  • Participate in cross-functional process development teams representing Pharmaceutical Development (5%)
  • Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance formulation and analytical operations (5%)
  • Present results in internal and external meetings (5%)



  • PhD with 0-2 years, or MSc with at least 4 years or BSc with suitable experience in pharmaceutical sciences, biochemistry, biological sciences, chemistry or other relevant discipline or in a pharmaceutical development capacity 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.
  • Previous experience in design, conduct and interpretation of extractable and leachables studies, understanding of toxicological assessments of extractables/leachables, and in assessment of process product contact leachables is required. 
  • Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus.
  • Position requires an overall understanding of protein degradation pathways and expertise in the analytics to identify and track such degradants as well as to formulate around such issues. 
  • Scientific understanding of factors impacting protein stability.
  • Ability to take initiative in problem solving.
  • Knowledge of cGMP and quality guidelines
  • 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



  • Successful candidate will have obtained a degree in pharmaceutical sciences, biochemistry, biological sciences, chemistry or other relevant discipline and have worked in the pharmaceutical or biotechnology industry in a formulation or pharmaceutical development capacity for following period;
  • PhD, 0-2 years
  • MSc, at least 4 years
  • BSc with comparable experience





New Haven, CT, United States


Alexion 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 additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.