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 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 \\n Rezolute (RZLT) currently anticipates the base salary for Senior Manager External Supplier Operations role could range from $165,000 to $180,000 and will depend, in part, on the successful candidate's geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's 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, education, experience and geographical location of the selected candidate. Qualifying employees are eligible to participate in 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.

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Senior Manager, External Supplier Operations