Stability Associate III at Alexion in New Haven, Connecticut

Job Description:

This is what you will do:



The Stability Associate III performs assigned tasks to support stability activities for Alexion's clinical phase biological candidates. Work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other member of Product Development and Clinical Supply (PDCS) as well as external vendors as required.



You will be responsible for:

• Design and management of stability studies for assigned Biological clinical program and support other development programs.
  
  


• Author stability Protocols, Reports, SOPs, and Quality documents.
  
  


• Work with internal stakeholders to provide testing requirements and obtain completed analytical test results.
  
  


• Work with CMOs and external storage vendor to obtain approved CoAs, quotes and stability protocols.
  
  


• Track and trend stability results generated internally and at external CMOs/ CLOs. Communicate trends outside of expected results to management.
  
  


• Maintain stability pull schedules, sample pulls and coordinate sample submission to test laboratories.
  
  


• Generate and maintain JMP data tables, perform data entry/verification as required, and trend data in support of expiry and investigations.
  
  


• Provide stability assessments in support of testing/laboratory investigations, shipping, or storage deviations
  
  

You will need to have:

• Master's degree with 3+ years of experience or Bachelor's degree with 5+ years of experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering, or related discipline consisting of a combination of appropriate education, training and/or directly related experience)
  
  


• Strong working knowledge of governing documents/regulations for pharmaceutical stability
  
  


• Knowledge of GxPs and their application in the pharmaceutical environment
  
  


• Ability to interact with cross-functional teams as stability SME
  
  


• Ability to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual needs to provide updates and tracking on his/her tasks
  
  


• Ability to communicate findings effectively to colleagues within and outside of the group through presentations and reports
  
  


• Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint
  
  


• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
  
  

We would prefer for you to have:

• Previous technical writing experience
  
  


• Previous experience with SAS JMP or other statistical software
  
  


• Previous experience with Laboratory Information Systems (LIMS)
  
  


• Knowledge of Lean Six Sigma
  
  

Date Posted

17-Jun-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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