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

Job Description:

This is what you will do:



The Scientist I will spend approximately 50% of work time in lab and 50% in office-based work.


The incumbent is expected to be involved in the design, development, validation, and execution of bioanalytical assays for small and large molecules in a regulated environment.


The incumbent is expected to independently develop and validate methods for regulated assays and develop and qualify fit-for-purpose bioanalytical assays for Alexion therapeutics at various stages of discovery and development.


The incumbent will be focused on innovative approaches in method development, such as DOE and lab automation.


In addition, the incumbent is expected to communicate cross groups and within cross functional teams, has persuasive writing and oral communication skills.


The incumbent will closely collaborate with R&D, clinical, and non-clinical colleagues to fulfill bioanalysis for clinical, non-clinical and R&D studies.



You will be responsible for:

• Function as a subject matter expert in the area of bioanalytical method development
  
  


• Drive the bioanalytical innovation by improving the quality and efficiency of method development and lab operation
  
  


• Serve as part of the BA sub-team, working with Bioanalytical project lead to support discovery or development projects for method qualification/validation, data reporting, and interpretation of issues associated with the bioanalytical results
  
  


• Transfer qualified and fit-for-purpose assays to CROs and serve as the primary point of contact for assay transfer and troubleshooting of technical assay issues within project specified timelines
  
  


• Integrate quality standards to ensure that bioanalytical data is fit-for-purpose (e.g. GLP compliance at CROs for regulated analyses)
  
  

You will need to have:

• 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 years of experience; BS degree relevant biological field with a minimum of 11 years of experience
  
  


• Experience with immunoanalytical methods, LCMS based methods and cell culture technique based assays for discovery support
  
  


• Experience performing method development using Design of Experiments (DOE) and lab automation
  
  


• Experience in organizing and managing multiple bioanalytical projects in the laboratory setting
  
  


• Scientifically independent - design, execute, analyze, interpret results, and reaches correct conclusions
  
  


• Well organized, motivated, team player, and works with a sense of urgency
  
  


• Experience in transferring assays to CROs, monitoring development/validation, and sample analysis
  
  

We would prefer for you to have:

• Experience in developing and validating bioanalytical assay in a regulated environment
  
  


• Experience in regulatory submission, e.g. NDA, BLA and interactions with health agencies
  
  

Date Posted

29-Oct-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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