Munich, Bavaria, Germany
the Leadership team and me as a formal head are responsibe to build and lead a global analyical development organization across several sites and countries for the development of Biosimilars.
Creating, growing and leading a analytical project leadership department with teams across 4 sites in 4 countries. Establishment of a senior (analytical) project management community overseeing all development phases for the Novartis Biologics portfolio from early development to FIH to BLA submission and LCM. Reporting to VP analytic development biologics. Providing Project leadership incl. project budget and demand forecasting within the analytic discipline at a scale of a mid size biotech company scale.
Leading a group of several lab teams incl analytical experts and analytic project leaders. Group size of up to 50 associates. Supporting Biologics process and analytic development of NBEs (new biological entities )and Biosimilars. Capex and budget responsibility, as well overall accountable for demand and capacity forecasting. Due to the close interaction and interlinkage, deep understanding of drug development processes (e.g. USP, DSP, etc. ) through different development phases.
Global operative project management of one or several full development Biosimilar programs. Close interaction with and support of the global program head/ program leader in all aspects of program strategy execution. Additional responsibility for supporting, organizing and documenting the monthly global Sandoz Biopharma Innovation Board Meeting.
Laboratory Head/ Team leader of an Analytical Lab with up to 10 associates. GMP and non-GMP Analyses of Biologic APIs including release analytics for clinical use. Method development and GMP compliant method validation and transfer (internal and from/to CMOs/ CROs).