Location: Colleretto Giacosa, Italy
Role Purpose:
Leads a Theragnostic Team comprising of Drug Product Project Leaders (DPPLs) / Formulation Project Leaders (FPLs) that are members of multiple technical development project teams in a global matrix organization by successfully setting up people and assets to best serve project needs according to priority. Ensure timely delivery of high-quality products and pharmaceuticals processes for radioligand therapy in line with TRD-NCE / RLT strategic priorities
Role Responsibilities:
• Ensures the optimal set up of people and assets, to best serve project needs consistently and with high quality. Makes sure that all deliverables are achieved against agreed upon project timelines and with committed resources for development, technological and technical life cycle management projects assigned to the team.
• Leads a Theragnostic Pharmaceutical Development Team responsible for Pharmaceutical Development and/or Clinical Manufacturing. Contributes members to multiple product development project teams and is responsible for a total of 10-15 associates.
• Contributes to definition and implementation of the global RLT strategy and ensures that both strategic and operational objectives for TRD RLT are met or exceeded by setting appropriate priorities for the team.
• Effectively manages the interface between the team and internal / external partners in other functions. (for e.g., ARD / PHAD / CHAD / QA / GCS / RA CMC / Manufacturing & supply operations etc.).Ensures quality, quantity and timelines in all assigned projects, networks and/or platforms.
• In close cooperation with the Head of RLT, drives the unit long-term strategic plan and its implementation. Ensures current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance
• Interacts/collaborates with Research, Development and/or Technical Operations to facilitate transfer of knowledge and deliveries of DS and DP and ensure successful filings and launches.
• Ensures all own activities are aligned with overall drug development process.
• Ensures the optimal set up of people, assets, and equipment in order to best serve project needs consistently and with high quality. Makes sure that all deliverables are achieved against agreed upon project timelines and with committed resources for development, technological and technical life cycle management projects assigned to the team.