Vice President, Global Manufacturing

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity. Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). Position Description: Overview A key member of Rezolute’s Technical Operations Leadership team, the Vice President, Global Manufacturing has the mandate to provide the vision, leadership, strategy and management skills to build, lead and oversee Rezolute’s fully externalized, global biologics manufacturing network, from cell line through Drug Product. The role is accountable for the reliable, robust and redundant manufacture of ersodetug in support of late-phase clinical supply, global submissions, approval, launch and continuous commercial supply. The Vice President, Global Manufacturing will build and lead executive-level relationships across the global service provider network, engaging both at the Site Head level and with above-site executive leadership to influence and resolve capability, capacity, reliability and readiness. The position reports to the Senior Vice President, Operations (and Head of Technical Operations), and works daily in partnership with the Head of Quality and the Vice President, Global Supply Chain to deliver one seamless manufacture and supply platform, while acting as a pivotal source of information for the RZLT Management Team and Board of Directors. This role may be performed remotely within the US. Principal Duties and Responsibilities Include: Charged with designing, developing and implementing the transition of Rezolute’s clinically oriented manufacturing operations toward a robust, reliable and redundant commercial manufacturing network, positioned to support global markets. In this, the organization must maintain its agile operational capability while installing the rigor necessary to meet market demand through a fully externalized network of service providers. Accountable for all externalized manufacturing from cell line through Drug Product, including cell line development, cell bank manufacture and maintenance, Drug Substance manufacture and Drug Product (aseptic fill-finish) manufacture, across a global network of qualified service providers. Accountable for the storage and depot facilities supporting the manufacturing network, including cell banks, Drug Substance and Drug Product held within the manufacturing network. Accountability for Drug Product transfers to the Global Supply Chain upon shipment of Drug Product from the manufacturing site. Accountable for the manufacturing elements of the current Plan of Record, inclusive of Drug Substance and Drug Product supporting two advanced P3 programs, now pre-BLA enabled and preparing for potential launches globally. Owns the Manufacturing Plan as a byproduct of the S&OP process led by the Global Supply Chain. Translates the consensus supply plan into Drug Substance and Drug Product campaign schedules, capacity reservations, slot commitments and critical materials plans; provides capacity, constraint and risk input to S&OP. Builds and sustains executive relationships with each service provider at the Site Head level and with above-site executive leadership, leveraging these relationships to influence priority, capacity and investment, and to resolve capability, reliability and readiness issues. Applies a tiered governance structure with each service provider (operational, site leadership and executive steering) to drive open, contemporaneous and clear understanding of conduct of work, costs, risks and deliverables, with defined escalat…

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