Associate Scientist III, Analytical Development and Clinical Supply

This is what you will do:

The Analytical Development Scientist position is a technical position responsible for supporting Analytical and Process Development utilizing early and late phase capillary methods including electrophoresis and Isoelectric focusing in support of DS and DP process development. This position will also support other analytical testing pertaining to characterization and investigation efforts, as well as long term stability for Alexion’s biotherapeutic products. Participation in method qualifications and troubleshooting of methods 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.

You will be responsible for:

• Perform routine testing, critical review of data, and maintain electronic laboratory notebook entries using good documentation practices
• Comprehensive analysis, trending, and assessment of experiment results to corresponding study design.
• Process Development, Stability and Characterization analytical support, optimization, and qualification in a range of analytical techniques including U/HPLC, capillary and plate based techniques.
• Take lead in molecule analytical responsibilities including tracking progress of testing, communicating pertinent details to team, and providing weekly updates on activities to manager.
• Support application of new innovative technologies to improve throughput and enhance capability of analytical control strategy
• Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams
  
  
  

You will need to have:

• B.Sc. degree in Chemistry, Biochemistry, Chemical Engineering, or related discipline.
• 3-5 years of analytical experience in protein/peptide separations by CE-SDS and/or cIEF in pharmaceutical or biotechnology company
• Scientific and practical knowledge of protein characterization for protein therapeutics including monoclonal antibodies and glycoproteins
• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development
• The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; 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:

• Experience with product quality testing, optimization, qualification, and validation for protein therapeutics.
• Experience with Lab On Chip and/or Maurice instruments and software
• Excellent people skills and a strong ability to communicate effectively
• Knowledge of cGMP and quality guidelines
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint
• Knowledge of Visual Basic application and creating complex macros
• Strong organization and time management skills
  
  
  

Experience working in fast-paced team environment