Development Scientist I, Bioanalytical Development at Alexion in New Haven, Connecticut

Job Description:

Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. Further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.



Position Summary



Development scientist I is able to plan, design, execute, and analyze all own work independently; able to complete assigned projects and self-identify projects; able to multi-task projects, assist in prioritization and allocating effort accordingly. The incumbent is able to solve complex problems, take initiatives, identifies creative solutions, have scientific curiosity and deep understanding of relevant science. In addition, the incumbent is able to communicate cross groups and within cross functional teams, has persuasive writing and oral communication skills. The incumbent closely collaborate with R&D, clinical, and non-clinical colleagues to fulfill bioanalysis for clinical, non-clinical and R&D studies.



Principal Responsibilities

• Engage in development and research projects independently, perform relevant testing/assays
  
  


• Engage in assay development and validation activities
  
  


• Perform relevant testing/assays and documentation for clinical and non-clinical study samples under GLP regulation; make detailed observations and documentation
  
  


• Performs development and/or research in collaboration with others independently
  
  


• Support other departments with testing and assay development as needed
  
  


• Perform LIMS and LIMS associated activities regarding sample, reagent and data inventory and tracking when it is needed
  
  


• Investigates, creates and develops new methods and technologies for project advancement independently
  
  


• Train employees on relevant laboratory techniques, SOPs, etc. as needed
  
  


• Maintains high level of professional expertise through familiarity with scientific literature
  
  


• Use professional concept and company's policies and procedures to solve complex problems in creative and effective ways
  
  


• Able to demonstrate potential for technical proficiency, scientific creativity, and collaboration with others and independent thought. Able to work on problems independently in which analysis of situation or data requires a review of identifiable factors. Excises judgment within defined procedures and practices to determine appropriate action
  
  


• Principal bioanalytical investigator or study director for non-clinical and clinical studies
  
  


• May participate in scientific conferences and contribute to scientific journals
  
  


• Adhere to GLP/GCP guidelines
  
  


• Operate all basic laboratory equipment and complex instruments
  
  


• Maintain laboratory and laboratory equipment/instrumentation. Order laboratory supplies/equipment as needed
  
  

Qualifications

• Ph.D. in a relevant scientific field with a minimum of 0-3 years of biotechnology-related experience; may include post-doctoral experience; MS degree in relevant biological science field with a minimum of 8-11+ years of experience; BS degree relevant biological field with a minimum of 11+ years of experience
  
  


• Good understanding of bioanalytical assay development, validation, and associated data analysis
  
  


• Working knowledge of regulatory guidance documents that pertain to the bioanalytical discipline
  
  


• Good writing and oral communication skills
  
  


• Hands-on bench experiments and data analyses
  
  


• Independently plan, design, execute and analyze all own work
  
  


• Contribute to assigned projects, and able to self-identify projects
  
  


• Able to multi-task projects, and prioritizes and allocates effort
  
  


• Can solve complex problems
  
  


• Take initiatives and identify creative solutions
  
  


• Good writing and oral communication skills
  
  


• Proficient in the use of Microsoft Word, Excel and PowerPoint
  
  

Education



Ph.D., MS or BS degree in relevant biological science field



Date Posted

18-Sep-2024



Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.


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