Lead formulation development programs, taking strong scientific ownership and coordinating external partners (e.g., CROs and CDMOs), while ensuring cross-functional alignment and data-driven decisions * Plan, design, conduct, and critically review complex experimental studies, integrating advanced and risk-based approaches (e.g., DoE, QbD, stability modeling) * Sound understanding of ICH/GMP requirements and experience preparing CMC documentation for regulatory submissions (e.g., IND, CTA, BLA/MAA) * Strong ability to drive scientific decisions, collaborate effectively in cross-functional teams (e.g., Analytics, Pilot Production, CMC/Regulatory stakeholders), and operate in a dynamic R&D environment * Experience in advanced drug delivery approaches (e.g., oral delivery, sustained-release systems) is considered a plus
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