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Build and coordinate early-stage small-molecule discovery project teams, owning strategy, prioritization, and key go/no-go decisions - from hit finding to early lead optimization, towards valorization; Drive the integration of computational methods into
Extrapolation (where appropriate), dose selection, trial design, PIP development and ongoing evaluation of data as generated. Transform PBPK and QSP analyses into actionable insights and communicate these findings effectively to project teams and
Lead technology transfers and regulatory submissions while managing multiple programs in line with CMC objectives and timelines. Apply Best Product at Pivotal and Speed to the Clinic principles, prioritize resources across competing programs, and ensure
Provide QA support and expertise to iPSC cell culture, cell banking, cell differentiation in bioreactor and aseptic manufacturing activities; Maintain a strong QA presence on the shop floor and promote a proactive, right-first-time quality culture;
Develop Manufacturing Industrial Strategic Supply Plans for Drug Products throughout their lifecycle, aligned with the broader supply-network strategy; Build and oversee the strategic industrial project portfolio covering launches, lifecycle management,