Senior Manager, Manufacturing Operations

Senior Manager Of Manufacturing Operations

Rezolute is a late-stage 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 seasoned professional to support its late-stage and pre-commercial external manufacturing operations. The Senior Manager of Manufacturing Operations will be a proactive, self-directed individual with a strong technical foundation and a clear understanding of the interface between Pharmaceutical Manufacturing, Quality Assurance, and external partners. This role requires the ability to interpret and communicate complex manufacturing information effectively across internal teams, business stakeholders, and CDMO partners.

This fast-paced role supports execution of manufacturing strategies that ensure reliable, right-first-time, and on-time supply to support global clinical trials and commercialization of RZ358. Reporting to the Senior Director of External Manufacturing, this position supports partnerships with contract development and manufacturing organizations (CDMOs) and contributes to delivery of project milestones across multiple Drug Substance (DS) and/or Drug Product (DP) sites. The individual will work closely with internal SMEs (MSAT and QA), Business stakeholders, and Supplier Relationship Management (SRM) to ensure coordinated execution of manufacturing activities.

Principle duties and responsibilities include:

• Support execution of Drug Substance (DS) and/or Drug Product (DP) manufacturing in accordance with approved plans, ensuring alignment with program timelines, supply requirements, and business priorities
• Serve as a technically informed liaison to internal SMEs (MSAT and QA), Business stakeholders, and Supplier Relationship Management (SRM) to help ensure manufacturing activities are coordinated and aligned with the Plan of Record (POR)
• Apply technical understanding of biologics manufacturing processes to support clear and effective communication across internal teams and CDMOs
• Work closely with Supplier Relationship Management (SRM), Business stakeholders, and Procurement (PO) to support scheduling, material readiness, and confirmation of manufacturing operations
• Support and help facilitate internal Manufacturing Operations alignment meetings to ensure cross-functional visibility and coordination
• Assist in coordination of technology transfer, start-up activities, validation, and clinical/commercial manufacturing to support continuity across CDMO partners
• Participate in internal and external technical sub-team meetings, including supplier-facing forums, to ensure consistency in communication and alignment to program and business objectives
• Support development and collection of manufacturing risk assessments; track risks and help ensure mitigation plans are progressing and visible to stakeholders
• Monitor manufacturing KPIs and communicate trends, risks, or issues to leadership, Business stakeholders, and SRM as appropriate
• Coordinate Master Batch Record (MBR) and Electronic Batch Record (EBR) review and approval workflows to ensure completeness and compliance
• Support tracking and progression of manufacturing change controls (internal and CDMO) through to closure
• Partner with QA and CDMOs to track and support resolution of deviations and investigations
• Support alignment of Manufacturing Supply Operational Plans with internal forecasts, program timelines, and business objectives
• Facilitate coordination of internal SMEs (QA, MSAT) and stakeholders to support timely execution of program deliverables
• Provide input into manufacturing-related scopes of work and contracts to ensure alignment with operational needs, supplier capabilities, and program strategy
• Support collaboration with Supplier Relationship Management (SRM) to ensure effective oversight of CDMO performance and partnership health
• Support tracking of manufacturing activities against budget and scope in collaboration with Finance, Business stakeholders, and leadership
• Contribute to development and use of PMO tools and manufacturing project management best practices
• Interface with PMO to support alignment of Tech Ops activities with broader program and business goals
• Support readiness activities for late-stage and commercial manufacturing, ensuring processes and documentation are aligned for scale, compliance, and supplier execution

Qualifications/requirements:

• Minimum Bachelor's degree in a relevant scientific discipline
• Minimum 8 years of relevant experience (industry, project management, or related), with small to mid-sized biotech experience preferred
• Demonstrated technical understanding of biologics (mAb) manufacturing, including Drug Substance (upstream/downstream) and/or aseptic Drug Product operations
• Ability to apply technical knowledge to support cross-functional communication and decision-making across Technical Operations, Business teams, and external partners
• Experience working with CDMOs and supporting external manufacturing operations; exposure to supplier or business interface is preferred
• Strong organizational and project coordination skills, with the ability to manage multiple activities and timelines
• Demonstrated ability to work independently in a fast-paced, matrixed environment
• Strong attention to detail and ability to track complex deliverables to completion
• Effective interpersonal and communication skills, with the ability to work across technical, operational, and business functions
• Basic understanding of cGMP requirements and quality systems, including change controls, deviations, and batch record review
• Proficiency in Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet

Rezolute (RZLT) currently anticipates the base salary for Senior Manager Manufacturing 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.