Vice President - Global Manufacturing

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 escalation paths.

• Develops and executes the global manufacturing network strategy, including redundancy, second-source and dual-site strategies for Drug Substance and Drug Product, business continuity planning and long-term manufacturing solutions aligned with corporate strategy and evolving goals.

• Accountable for the robustness and reliability of manufacture; establishes and manages service provider performance to Right First Time and On Time In Full expectations through defined KPIs, routine performance review and corrective action.

• Accountable for identification and mitigation of risks to the manufacture and supply of Drug Substance and Drug Product; routinely assesses risks within the span of control, creates and implements effective mitigation plans, escalating as appropriate.

• Builds and leads a Manufacturing Technical team to support routine manufacture, including person-in-plant oversight, campaign technical monitoring, batch record and process performance review, and technical leadership of deviation and investigation resolution at service providers.

• Builds redundant, reliable capability across the manufacturing platform, enabling site transfers through to registration by establishing the service provider relationship and leading program, contract and deliverable management. Partners with the MSAT team within Quality, which owns technical specification, characterization, qualification and validation, and Module 3 authorship.

• Leads the team to collaboratively (Quality, MSAT and the Technical Operations Leadership) resolve deviations, investigations and CAPAs, enabling on-time, reliable supply.

• Supports global submissions and pre-approval inspection readiness at service providers in concert with Quality and Regulatory teams.

• Works as part of a broader Technical Operations Leadership team, striving for open, honest communication and collaboration.

Areas of specific responsibility include:

• Build, lead, manage and develop a best-in-class, high-performance, phase-appropriate team, including external manufacturing leads for Drug Substance and Drug Product, cell line and cell bank management, manufacturing planning and the Manufacturing Technical team.

• Build phase-appropriate manufacturing systems, procedures and governance for service provider oversight, manufacturing planning, performance management and executive escalation.

• Work diligently with the Head of Quality to maintain seamless integration with all aspects of the Quality team, including batch disposition support, deviation and change control, supplier qualification and audits, and inspection readiness; support the Head of Quality with respect to registrational compliance evaluation and ongoing release of drug.

• Partner with the Vice President, Global Supply Chain to ensure a seamless handoff of Drug Product from the manufacturing network to the global supply chain, and alignment between the Manufacturing Plan and the FDP supply plan.

• Ensure the management of all financial aspects of manufacture, including contracts, budgeting, forecasting, long-range planning, capacity commitments and Cost of Goods for Drug Substance and Drug Product.

• Lead development of relationships and contracting with service providers, including master services, supply, capacity reservation and technical agreements; ensure all manufacturing agreements are effectively negotiated to meet the near- and long-term needs of Rezolute in a cost-efficient manner, as agreed with Legal, Finance, Quality and functional heads.

• Coordinate the selection and oversight of service providers and suppliers of critical raw materials, consumables and primary components for Drug Substance and Drug Product.

• Work cross-functionally to identify product lifecycle needs (e.g., scale, presentation and line changes), enabling feasibility and implementation in concert with MSAT, product and corporate strategy.

• Review technical documentation and summaries to ensure sound rationale, conformance with regulations and existing approvals, and challenge where appropriate the effectiveness of these documents to deliver on the intended purpose.

Qualifications/Requirements - We are looking for a candidate with:

• B.S. in Engineering, Life Sciences or related field is required; advanced degree preferred.
• 15+ years of biologics manufacturing experience within biotech/biopharmaceutical organizations, including 5–7+ years in senior leadership with demonstrated executive experience at the Vice President or Executive Director level.
• Demonstrated hands-on experience building an external manufacturing function, its systems, procedures and team, in the context of a late phase to commercial biotech; Rare Disease experience highly preferred.
• Expertise in monoclonal antibody Drug Substance and aseptic fill-finish Drug Product manufacturing required; technical awareness of cell line development preferred.
• Commercial launch experience required, including PPQ, BLA/MAA submission support, pre-approval inspection readiness and transition to commercial supply.
• Track record of executive relationship management with CDMOs, at the Site Head level and above-site, resulting in resolution of capacity, capability and reliability issues.
• Demonstrated experience establishing manufacturing redundancy, second-source or dual-site supply for biologics.
• Experience negotiating master services, supply and capacity reservation agreements.
• Comfort in leading through influence, acting with agility, leading problem solving and driving toward robust solutions; communication is a critical strength, demonstrated at all levels of the organization; sense of humor and humility are essential.
• Position may require morning, evening and/or weekend commitments as the RZLT team is spread across the US, and service providers are located offshore.
• Position requires domestic and international travel (up to 50%).
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that has:
• Experience with multiple CDMO networks across the US, EU and Asia.
• Board- and executive-level communication of manufacturing risk and strategy.
• Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect.