Responsibilities

• Lead the analytical aspects of a project including method development and validation, control strategy development, specification justification, data generation, and regulatory submission contributions.
• Leverage experience in analytical techniques relevant to peptide product development including mass spectrometry, chromatography, amino acid analysis, advanced separation techniques, and higher-order structure studies.
• Understand and apply advanced analytical techniques to generate extended characterization data packages to build product knowledge and support regulatory requirements.
• Build deep knowledge of API processes spanning starting materials, intermediates, impurities, and the API to implement analytical controls and testing to enhance process and product knowledge. 
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Process, interpret, and visualize data to facilitate project team decisions.
• Communicate and collaborate with cross-functional groups and departments.
• Routinely demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance, where applicable.