Teams at Otsuka America Pharmaceutical

Leads analytical development strategy and testing for pharmaceutical small molecules and related modalities. Oversees contract laboratories, method development, validation, transfer, stability studies, data review, and regulatory support from early development through commercialization. Provides analytical insights for drug substance and product development, authors technical and CMC documents, manages risks and budgets, ensures GxP and regulatory compliance, and mentors team members.

Manages pharmaceutical supply chain planning, sourcing, inventory, replenishment, distribution, logistics, and vendor relationships. Leads S&OP processes, coordinates manufacturing and packaging suppliers, monitors performance and supply risks, resolves distribution issues, manages ERP transactions and budgets, and ensures compliance with GxP, SOP, serialization, and DSCSA requirements. Collaborates with cross-functional teams to maintain product availability, optimize costs, and support new product launches.

Leads integration, analysis, visualization, and interpretation of biologics CMC data from IND-enabling studies through commercialization. Partners with analytical, process development, MSAT, quality, and regulatory teams to evaluate trends, variability, comparability, method performance, and control strategies. Translates complex datasets into regulatory narratives and defensible CMC decisions, while ensuring data quality, traceability, reconciliation, and readiness for submissions, technology transfers, and manufacturing changes.