Senior Manager, External Supplier Operations

Rezolute is a pre-commercial ultra-rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).

Rezolute is seeking a proactive, self-directed professional to support its late-stage and pre-commercial external manufacturing operations. The Senior Manager, External Supplier Operations will support the execution and oversight of external manufacturing programs, with a focus on supplier coordination, technology transfer, manufacturing readiness, and delivery of critical program milestones.

This role will establish and maintain the operating cadence required to ensure external supplier activities remain aligned with Rezolute's Plan of Record (POR), program timelines, supply requirements, and business priorities. The individual will manage schedules, dependencies, deliverables, risks, and action items; facilitate internal and external meetings; and provide clear visibility to program status and emerging issues.

The successful candidate will have experience working with contract development and manufacturing organizations (CDMOs) and managing external manufacturing programs from an operational and project execution perspective. A strong knowledge of biopharmaceutical manufacturing is important to enable informed communication and effective coordination with technical SMEs, although this role is not intended to serve as the primary technical subject matter expert. The individual will work closely with Manufacturing Operations, MSAT, QA, Supplier Relationship Management (SRM), Business stakeholders, Supply Chain, Procurement, and external suppliers to ensure effective execution of manufacturing activities.

• Support execution of external Drug Substance (DS) and Drug Product (DP) manufacturing programs in accordance with approved plans, timelines, supply requirements, and business priorities
• Coordinate technology transfer, supplier onboarding, and manufacturing readiness activities, including integrated schedules, milestones, dependencies, critical path activities, and deliverables
• Maintain detailed visibility to supplier commitments and proactively identify schedule risks, gaps, and issues that may impact program execution
• Lead internal supplier operations and manufacturing coordination meetings, including preparation, action tracking, decision documentation, and follow-up
• Coordinate internal and external cross-functional activities across Manufacturing Operations, MSAT, QA, Business, Supply Chain, SRM, Procurement, and supplier teams
• Partner with MSAT and other technical SMEs to incorporate technical activities and decisions into program plans and ensure technical issues are appropriately communicated and tracked
• Serve as a key operational interface with external suppliers, ensuring commitments, action items, and deliverables are clearly understood and progressed to completion
• Support Supplier Relationship Management (SRM) and Business stakeholders in monitoring supplier performance and resolving execution issues
• Develop and maintain manufacturing plans, schedules, dashboards, and status reports to provide clear visibility to program progress and alignment with the POR
• Track program risks, issues, assumptions, decisions, and dependencies; coordinate mitigation activities and elevate material risks as appropriate
• Monitor supplier performance against agreed timelines, deliverables, and KPIs and communicate significant trends or areas requiring attention
• Coordina…