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Represent the site in cross-functional project teams (e.g. Product Launches, Program Management) and ensure the coordination of all activities locally
Set up and lead local project teams to ensure the implementation of local and global Life...
Area of Responsibility
The Analytical Science & Technology department is responsible for the coordination and management of all analytical related activities of commercialized Biosimilar products
Presentation and discussion of...
Maintain overview of product process performance over sites and the value chain, drive continuous improvement plans at site level
Ensure product processes are in constant state of validation end to end, across multiple sites in liaison with...
Quality assurance tasks with focus on activities regarding medical devices
Support in quality topics, e.g. deviations, complaints, CAPAs
Support in QA Lab for investigation of samples
Participation in the release process of medical...
QA oversight of documentation management processes with respect to fulfill authority guidelines and Novartis/Sandoz standards
QA contact person for the implementation of the new Novartis documentation management IT system D4N
Plan, execute and evaluate experiments for cell culture process optimization and characterization of biosimilar pipeline products
Contribute actively to inoculum development, medium/feed development, process transfer, characterization or...
Leading an analytical team of 5 to 10 associates: resource planning, Instrument qualification, experimentation and method development, data handling and data management for the analysis and development of a biopharmaceutical project...
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Plan, organize, perform and document scientific experiments for the analytical development of biopharmaceuticals
Develop and apply methods for protein parameters and excipients
Prepare and review analytical reports
Drive detailed planning, scheduling and order management to assure agreed delivery performance level
Develop and manage the relationship with External Suppliers and customers for all supply related matters
Meet with CMOs to discuss and...