Analytical Project Lead

Your responsibilities

• Coordination of analytical activities and compilation of analytical documentation to support the project

• Actively managing analytical knowledge of the project by communicating to all people involved in analytical activities and having an overview on these activities

• Overseeing and coordinating method development, stability indicating studies, method qualification and validation, method transfer, method monitoring and improvement

• Supporting all analytical activities to increase understanding of all properties of a molecule quality attribute assessment, defining the stability profile of the molecule and structure-function relationships

• Overseeing and coordinating specific analytical activities of a certain project, i.e.: comparability studies, establishment of analytical standards

• Participating in project team meetings and other project related meetings representing all analytical aspects of the project

• Compiling documentation: product specifications, sampling plans, analytical method transfer protocols and reports, leachable and extractable studies

• Supporting preparation of reports of other departments (e.g. USP development, DSP development, manufacturing) by providing analytical data collected in analytical departments, both R&D and QC, and support interpretation of these data

• Supporting any troubleshooting activities with analytical knowledge

• Coordinating and performing analytical activities

• Presenting analytical topics related to the project during internal and external audits

• Supporting preparation of regulatory submissions as well as participation in meetings with regulatory authorities as needed

• Preparation, reviewing of procedures, protocols and reports

• Communication with external companies to align on analytical tasks

Our requirements