enGene Holdings Inc. logo

Head of Supply Chain

enGene Holdings Inc.
1 month ago
Full-time
Remote
Worldwide
Operations

Key Responsibilities

    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.

Required Experience

    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.

Leadership Profile

  • 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.