Build the Commercial Supply Chain Function
路 Design and implement the commercial supply chain operating model.
路 Establish demand planning, supply planning, inventory management, and S&OP processes.
路 Define systems, tools, KPIs, and governance required to support launch and growth.
路 Build and develop a scalable team aligned with anticipated commercial expansion.
Launch Readiness & Execution
路 Lead cross-functional launch supply planning in partnership with Commercial, Regulatory, Quality, and Finance.
路 Develop and execute launch readiness plans including labeling, packaging, serialization, distribution setup, and initial inventory build.
路 Conduct scenario planning and supply risk assessments pre- and post-approval.
External Manufacturing & Partner Oversight
路 Manage and oversee both Clinical & Commercial supply relationships with CMOs/CDMOs.
路 Negotiate both clinical & commercial supply agreements and long-term capacity commitments.
路 Implement performance metrics and governance processes with external partners.
路 Ensure alignment between forecasted demand and manufacturing capacity.
Global Distribution & Logistics
路 Design and qualify a compliant global distribution network.
路 Oversee cold chain strategy, import/export processes, and GDP compliance.
路 Select and manage 3PL providers.
路 Implement inventory visibility and track-and-trace systems.
Compliance & Regulatory Support
路 Ensure commercial supply chain readiness for regulatory approval.
路 Support regulatory submissions with supply chain documentation.
路 Partner with Quality to ensure GMP/GDP compliance across external partners.
路 Lead supply chain readiness for pre-approval inspections (PAIs).
Risk Management & Business Continuity
路 Develop and implement a supply risk management framework covering both clinical and commercial supply.
路 Establish contingency plans for single-source suppliers.
路 Lead supply continuity strategy during regulatory and launch transitions.
Financial Stewardship
路 Develop and manage the supply chain budget.
路 Optimize working capital while maintaining service levels.
路 Align supply strategy with gross margin and long-term profitability targets and drive strategic second source activation for supply security and cost reduction opportunities.
路 15+ years in biotech/pharma supply chain with commercial-stage experience.
路 Direct experience supporting at least one first product launch in biotech.
路 Experience building supply chain infrastructure in a pre-commercial company.
路 Strong expertise managing CMOs and external manufacturing networks.
路 Deep understanding of GMP/GDP requirements.
路 Knowledge of serialization, labeling, and global distribution requirements.
路 Experience implementing S&OP/ERP processes fit to an emerging biotech company.
路 Builder mindset with comfort creating structure from ambiguity.
路 Hands-on and strategic leadership to drive product launch and global supply chain operations
路 Strong cross-functional collaborator with influence skills.
路 Risk mitigator with strong functional expertise and a multi-disciplinary mindset who delivers early risk identification and drives collaborative mitigation plans.