In this dynamic and impactful role, you will play a key part in supporting analytical activities within an international pharmaceutical project. Your main responsibilities include:
- Supporting project and resource planning for all analytical activities at the site close to Munich in close collaboration with the local Project Lead and the local team.
- Independently coordinating, executing, and documenting method transfers, method development, validation, and verification of various complex analytical methods (e.g., HPLC, AAS, KF), both internally and with external laboratories.
- Performing analytical testing as well as preparing protocols and reports in accordance with GMP requirements and internal quality standards.
- Reviewing and assessing existing methods regarding practicality, compliance with EU and US GMP validation requirements, and regulatory status; performing further method development and validation as needed.
- Independently troubleshooting method‑related and instrument‑specific issues, with access to a global expert network across multiple laboratories.
- Identifying opportunities for method improvements, modernization, and enhanced robustness.
- Contributing to the review and verification of laboratory records, plans, and reports from other projects, as well as preparing procedural documents.
- Preparing analytical documentation to support regulatory submissions.
- Supporting multiple analytical transfer activities simultaneously.