Senior Expert – Analytical Characterization - Holzkirchen, Deutschland - Novartis

Beschreibung

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

• Independently manage project activities in the area of analytical characterization (e.g. method-development for characterization of the API, as well as their optimization, validation, -transfer including the know-how and troubleshooting, and ensure their implementations etc.) and contribute to project-specific strategy decisions.
• Represent the function in technical teams (e.g. global CMC team); perform all project tasks (e.g. design, plan, and support conducting scientific experiments; actively contribute to budget and resource forecast etc.) and responsibilities related to own scope of work, as well as assist leadership team in setting goals, performance evaluations, and development planning discussions with team members.
• Review and approve analytical results. Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share with the analytical sub-team.
• Author development reports, study protocols, laboratory procedures, or project-related SOPs; write scientific documents for key collaborators (e.g., other line units, health authorities).

coordinate and compile high quality analytical registration documents for HA submissions and write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits and inspections.