Summary
Location: Ivrea, Italy
Role Purpose
Define, lead and manage the analytical project strategy including the overall analytical control strategy for Drug Substance(s) and radiopharmaceutical parenteral Drug Product(s) in line with the overall CMC project development plan; ensure project specific high quality analytical submission documents. Support / mentor analytical team members and thereby contribute to the overall Technical Research and Development strategies and goals
About The Role
Role responsibilities:
1. Define and develop an overall science and quality driven analytical project strategy including contingency plans and risk evaluations for RLT DS and RLT DP.
2. Ensure transparent communication to the appropriate management level and / or to any other relevant project team members(s).
3. Be a core member of the TRD sub-team representing RLT Analytical Science; co-own the technical development together with the DSPL and RLT DPPL, actively contribute to the definition of the overall technical development plan.
4. Lead & coordinate, together with RLT analytical experts and subject matter experts, analytical activities (such as method development and validation, DS/DP stability, DS/DP release, reference nomination and