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.
Principle Duties and Responsibilities Include:
- 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 escalate material risks as appropriate
- Monitor supplier performance against agreed timelines, deliverables, and KPIs and communicate significant trends or areas requiring attention
- Coordinate manufacturing readiness activities associated with technology transfer, start-up, validation, and clinical and commercial manufacturing
- Coordinate MBR/EBR review activities and other internal review and approval workflows, ensuring stakeholders remain aligned to established timelines
- Track manufacturing change controls, deviations, investigations, and other quality-related deliverables that may impact manufacturing schedules, working closely with QA and technical SMEs
- Provide operational and project management input into manufacturing-related scopes of work, contracts, and supplier deliverables in partnership with External Manufacturing leadership, SRM, Business, and Procurement
- Support financial and scope tracking for external manufacturing activities, including planned work, supplier deliverables, and changes to scope
- Prepare concise program updates for leadership, highlighting progress, key risks, decisions required, and actions needed to maintain execution
- Proactively identify potential schedule impacts and work with appropriate functional owners and suppliers to develop practical solutions
- Support commercial readiness by ensuring key manufacturing, technology transfer, and supplier deliverables are incorporated into integrated program plans and completed on schedule
- Contribute to continuous improvement of External Manufacturing processes, tools, and operating practices as the organization and supplier network evolve
Qualifications/Requirements:
- Minimum Bachelor's degree in scientific, engineering, technical, or related discipline
- Minimum 7 years of relevant experience in the biopharmaceutical industry, including experience in project, program, manufacturing, or external operations management
- Demonstrated experience working with contract development and manufacturing organizations (CDMOs) and managing external manufacturing activities from a program or operational perspective
- Experience supporting technology transfers, manufacturing programs, supplier onboarding, or other complex external manufacturing activities
- Working knowledge of biopharmaceutical manufacturing, preferably Drug Substance manufacturing, sufficient to effectively communicate with technical SMEs and external supplier personnel
- Demonstrated ability to manage complex schedules with multiple workstreams, dependencies, milestones, and cross-functional contributors
- Strong project and program coordination skills with demonstrated ability to establish structure, maintain accountability, and drive deliverables to completion
- Strong interpersonal and communication skills, with the ability to work effectively across technical, operational, business, and supplier organizations
- Ability to independently organize and prioritize multiple competing activities in a fast-paced, matrixed environment
- Demonstrated ability to identify risks and issues early, understand their potential program impact, and escalate appropriately
- Strong attention to detail and follow-through, particularly in tracking deliverables and ensuring commitments are closed
- Ability to understand technical discussions and translate complex information into clear project actions, decisions, timelines, and risks
- Experience working with cross-functional teams including Manufacturing Operations, MSAT, Quality, Supply Chain, Procurement, SRM, and external suppliers
- Experience in a small to mid-sized biotech environment preferred
- Experience supporting late-stage clinical or commercial manufacturing programs preferred
- Basic understanding of cGMP requirements and pharmaceutical quality systems preferred
- Proficiency in Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet
- External Supplier Execution: Ability to coordinate CDMO activities and maintain accountability for supplier commitments and deliverables
- Program Coordination: Creates structure around complex programs and drives activities toward completion
- Technical Fluency: Understands biopharmaceutical manufacturing sufficiently to engage credibly with technical teams without serving as the primary technical SME
- Communication: Clearly communicates program status, risks, decisions, and actions across technical and non-technical stakeholders
- Ownership: Proactively identifies what needs to happen next and drives follow-through with minimal direction
- Collaboration: Builds effective working relationships across Manufacturing Operations, MSAT, QA, SRM, Business, Supply Chain, PMO, and external partners
- Problem Solving: Identifies issues early, engages the appropriate stakeholders, and drives toward practical resolution
- Execution Discipline: Maintains attention to detail while keeping sight of broader program objectives and business priorities
Core Competencies:
Skills Required
- Bachelor’s degree in a scientific, engineering, technical, or related discipline
- At least 7 years of relevant biopharmaceutical industry experience in project, program, manufacturing, or external operations management
- Experience working with contract development and manufacturing organizations and managing external manufacturing activities
- Experience supporting technology transfers, manufacturing programs, supplier onboarding, or complex external manufacturing activities
- Working knowledge of biopharmaceutical manufacturing, preferably Drug Substance manufacturing
- Ability to manage complex schedules with multiple workstreams, dependencies, milestones, and cross-functional contributors
- Strong project and program coordination skills
- Strong interpersonal and communication skills across technical, operational, business, and supplier organizations
- Ability to independently organize and prioritize competing activities in a fast-paced, matrixed environment
- Ability to identify risks and issues early, assess program impact, and escalate appropriately
- Strong attention to detail and follow-through in tracking deliverables and commitments
- Ability to translate complex technical information into project actions, decisions, timelines, and risks
- Experience working with Manufacturing Operations, MSAT, Quality, Supply Chain, Procurement, SRM, and external suppliers
- Experience in a small to mid-sized biotech environment
- Experience supporting late-stage clinical or commercial manufacturing programs
- Basic understanding of cGMP requirements and pharmaceutical quality systems
- Proficiency in Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet
What We Do
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). For more information, visit: www.rezolutebio.com.
