Vice President, Global Manufacturing

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver vision, leadership, strategy, and management for Rezolute’s externally managed global biologics manufacturing network from cell line development to Drug Product.

• Ensure reliable, robust, and redundant production of ersodetug for late-phase clinical supplies, global submissions, approvals, launches, and continuous commercial supply.

• Cultivate and lead executive relationships with global service providers at Site Head and higher leadership levels.

• Develop and execute the transition from clinically focused manufacturing operations to a resilient commercial manufacturing network.

• Supervise cell line development, cell bank manufacturing and maintenance, Drug Substance production, and aseptic fill-finish Drug Product production.

• Oversee storage and depot facilities that support the manufacturing network.

• Own the Manufacturing Plan, converting the consensus supply plan into campaign schedules, capacity reservations, slot commitments, and critical materials plans.

• Create and implement global manufacturing network strategies, including redundancy, second-source, dual-site, and business continuity plans.

• Establish and oversee service provider performance against Right First Time and On Time In Full metrics through KPIs, performance evaluations, and corrective actions.

• Identify and address manufacturing and supply risks.

• Build and lead a Manufacturing Technical team focused on routine manufacturing, technical monitoring, batch record and process performance review, and deviation and investigation resolution.

• Manage site transfers through registration and oversee service provider programs, contracts, and deliverables.

• Assist with global submissions and pre-approval inspection readiness in collaboration with Quality and Regulatory teams.

• Build and nurture a high-performance team across Drug Substance, Drug Product, cell line, cell bank management, manufacturing planning, and Manufacturing Technical functions.

• Establish manufacturing systems, procedures, and governance for overseeing service provider performance.

• Collaborate with Quality on batch disposition, deviations, change control, supplier qualification, audits, inspection readiness, and regulatory compliance.

• Work with Global Supply Chain on Drug Product handoff and ensure alignment between manufacturing and supply plans.

• Manage the financial aspects of manufacturing, including contracts, budgeting, forecasting, capacity commitments, and Cost of Goods.

• Lead service provider relationships and negotiate master services, supply, capacity reservation, and technical agreements.

• Coordinate the selection and oversight of service providers and critical material suppliers.

• Identify product lifecycle needs and review technical documentation for regulatory compliance and effectiveness.

⛳️ Requirements

• A B.S. in Engineering, Life Sciences, or a related field is required; an advanced degree is preferred.

• Over 15 years of experience in biologics manufacturing within biotech/biopharmaceutical organizations, including 5–7+ years in senior leadership roles demonstrating executive experience at the Vice President or Executive Director level.

• Proven hands-on experience in building an external manufacturing function, its systems, procedures, and team, particularly in the context of transitioning from late-phase to commercial biotech; experience with Rare Diseases is highly preferred.

• Required expertise in monoclonal antibody Drug Substance and aseptic fill-finish Drug Product manufacturing; technical knowledge of cell line development is preferred.

• Experience in commercial launch processes is required, including PPQ, BLA/MAA submission support, pre-approval inspection readiness, and transition to commercial supply.

• A strong track record of managing executive relationships with CDMOs at the Site Head level and above-site, leading to resolution of capacity, capability, and reliability challenges.

• Demonstrated experience in establishing manufacturing redundancy, second-source, or dual-site supply for biologics.

• Experience in negotiating master services, supply, and capacity reservation agreements.

• The position may require morning, evening, and/or weekend commitments, as the RZLT team is spread across the US, and service providers are located overseas.

• Domestic and international travel may be required (up to 50%).

• Experience with multiple CDMO networks across the US, EU, and Asia is preferred.

• Preferred experience in board- and executive-level communication regarding manufacturing risk and strategy.

🏝️ Benefits

• Annual performance bonus

• Competitive compensation

• Stock options

• Health Insurance (Medical / Dental / Vision)