Analytical Project Lead

In this position you will be responsible for project management and you will be the single point of contact for all analytical topics within the project – from development to product discontinuation.

• 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

• University degree (biotechnology, analytical chemistry, biochemistry, pharmacy, or related)
• Practical and theoretical knowledge about development, transfer and validation of analytical methods, stability studies, liquid chromatography concerning work with biological drugs (such as: peptide mapping, SEC, IEC, HILIC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopeial methods used for released raw materials, intermediates and final drug products
• 5 years’ experience in regulated laboratory environment (biotech lab preferably)
• Very good knowledge of GLP and GDP rules
• Project management experience
• Fluent English