Responsibilities 

• Responsible for leading the analytical aspects of a project including control strategy development, specification justification, method development and validation, data generation, and regulatory submission contributions.
• Proficiency with the relevant analytical techniques to support development of peptide products including the active pharmaceutical ingredient, intermediates, starting materials, impurities and impurity profiling.
• Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data to support regulatory requirements.
• Highly autonomous and productive in performing laboratory research or method development independently, requiring only minimal direction from a supervisor.
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• May initiate new area...