Senior Manager, External Supplier Operations
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 Rezolutes 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 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
- Minimum Bachelors 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
Core Competencies:
- 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
Rezolute(RZLT) currentlyanticipatesthe base salary for Senior Manager External Supplier Operations role could range from $165000 to $180000and will depend in part on the successful candidates geographical location and their qualifications for the role including education and experience. This position will also be eligible for an annual performance bonusin accordance withthe terms of the applicable plan (depending in part on company and individual performance and at the Companys discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications educationexperienceand geographical location of the selected candidate.
Qualifying employees are eligible toparticipatein benefit programs such as:
Health Insurance (Medical / Dental / Vision)
Disability Life & Long-Term Care Insurance
Holiday Pay
Tracking Free Vacation Program
401(k) Plan Match
Educational Assistance Benefit
Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race ethnicity gender veteran status or on the basis of disability or any other federal state or local protected class.
Required Experience:
Senior Manager
About Company
Rezolute is a clinical‑stage biopharmaceutical company developing transformative therapies—such as the monoclonal antibody ersodetug (RZ358) in Phase 3 for congenital hyperinsulinism and the oral plasma kallikrein inhibitor RZ402 in Phase 2 for diabetic macular edema—to treat rare met ... View more
