Vice President, Global Manufacturing

Rezolute•Redwood City, CA

19h•Remote

About The Position

Rezolute is a late-stage rare disease biopharmaceutical company developing therapies for severe metabolic and endocrine disorders. Its lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for hypoglycemia caused by congenital and acquired forms of hyperinsulinism. The Vice President, Global Manufacturing is a key member of the Technical Operations Leadership team and provides vision, leadership, strategy, and management for Rezolute’s fully externalized global biologics manufacturing network, from cell line through Drug Product. The role is accountable for reliable, robust, and redundant manufacture of ersodetug to support late-phase clinical supply, global submissions, approval, launch, and ongoing commercial supply. It reports to the Senior Vice President, Operations (and Head of Technical Operations) and works closely with the Head of Quality and Vice President, Global Supply Chain. The position may be performed remotely within the US. The role will transition clinically oriented manufacturing operations toward a robust commercial network while preserving agility and establishing the rigor needed to meet market demand. It oversees external manufacturing, storage, and depot facilities across qualified service providers; owns the Manufacturing Plan derived from the S&OP process; and manages provider relationships, governance, performance, capacity, risk, financial matters, and manufacturing agreements. The position also builds and leads a phase-appropriate team and manufacturing systems, supports submissions and inspection readiness, and collaborates across Manufacturing, Quality, MSAT, Regulatory, Supply Chain, Legal, and Finance.

Requirements

Bachelor of Science in Engineering, Life Sciences, or a related field.
At least 15 years of biologics manufacturing experience within biotech or biopharmaceutical organizations.
At least 5–7 years in senior leadership, with demonstrated executive experience at the Vice President or Executive Director level.
Hands-on experience building an external manufacturing function, including its systems, procedures, and team, in a late-phase-to-commercial biotech context.
Expertise in monoclonal antibody Drug Substance and aseptic fill-finish Drug Product manufacturing.
Commercial launch experience, including PPQ, BLA/MAA submission support, pre-approval inspection readiness, and transition to commercial supply.
Track record of executive relationship management with CDMOs at Site Head level and above-site, resolving capacity, capability, and reliability issues.
Experience establishing manufacturing redundancy, second-source, or dual-site supply for biologics.
Experience negotiating master services, supply, and capacity reservation agreements.
Ability to lead through influence, act with agility, lead problem solving, and drive robust solutions.
Strong communication skills demonstrated at all levels of an organization; humility and a sense of humor are also expected.
Ability to accommodate possible morning, evening, and/or weekend commitments because the team is spread across the US and service providers are offshore.
Ability to travel domestically and internationally up to 50%.

Nice To Haves

An advanced degree.
Rare Disease experience.
Technical awareness of cell line development.
Experience with multiple CDMO networks across the US, EU, and Asia.
Experience communicating manufacturing risk and strategy at Board and executive levels.

Responsibilities

Design, develop, and implement the transition from clinically oriented manufacturing operations to a robust, reliable, redundant commercial manufacturing network supporting global markets.
Oversee externalized manufacturing from cell line through Drug Product, including cell line development, cell bank manufacture and maintenance, Drug Substance manufacture, and aseptic fill-finish Drug Product manufacture.
Oversee storage and depot facilities supporting the manufacturing network, including those holding cell banks, Drug Substance, and Drug Product.
Manage accountability for Drug Product through shipment from the manufacturing site, at which point accountability transfers to Global Supply Chain.
Manage manufacturing elements of the current Plan of Record, including Drug Substance and Drug Product supporting two advanced P3 programs preparing for potential global launches.
Own the Manufacturing Plan derived from the S&OP process; translate the consensus supply plan into campaign schedules, capacity reservations, slot commitments, and critical materials plans, and provide capacity, constraint, and risk input to S&OP.
Build and sustain executive-level relationships with service providers at Site Head and above-site levels to influence priority, capacity, investment, and resolution of capability, reliability, and readiness issues.
Establish tiered service-provider governance, including operational, site leadership, and executive steering structures, with clear expectations, costs, risks, deliverables, and escalation paths.
Develop and execute the global manufacturing network strategy, including redundancy, second-source and dual-site strategies, business continuity planning, and long-term manufacturing solutions.
Establish and manage service-provider performance expectations for Right First Time and On Time In Full through KPIs, routine reviews, and corrective actions.
Identify and mitigate risks to Drug Substance and Drug Product manufacture and supply, implement mitigation plans, and escalate as appropriate.
Build and lead a Manufacturing Technical team responsible for routine manufacturing support, person-in-plant oversight, campaign monitoring, batch record and process performance review, and technical leadership of deviations and investigations.
Develop redundant, reliable manufacturing capabilities and enable site transfers through registration by managing service-provider relationships, programs, contracts, and deliverables.
Partner with the MSAT team within Quality, which owns technical specification, characterization, qualification, validation, and Module 3 authorship.
Collaborate with Quality, MSAT, and Technical Operations Leadership to resolve deviations, investigations, and CAPAs and enable reliable, on-time supply.
Support global submissions and pre-approval inspection readiness at service providers with Quality and Regulatory teams.
Build, lead, manage, and develop a high-performance, phase-appropriate team covering external manufacturing for Drug Substance and Drug Product, cell line and cell bank management, manufacturing planning, and manufacturing technical support.
Establish phase-appropriate systems, procedures, and governance for service-provider oversight, manufacturing planning, performance management, and executive escalation.
Work with the Head of Quality on integration with Quality activities, including batch disposition support, deviation and change control, supplier qualification and audits, inspection readiness, registrational compliance evaluation, and ongoing drug release.
Partner with the Vice President, Global Supply Chain to ensure a seamless Drug Product handoff and alignment between the Manufacturing Plan and the FDP supply plan.
Manage financial aspects of manufacturing, including contracts, budgeting, forecasting, long-range planning, capacity commitments, and Drug Substance and Drug Product Cost of Goods.
Lead service-provider relationships and contracting, including master services, supply, capacity reservation, and technical agreements; negotiate agreements to meet near- and long-term needs cost-effectively in coordination with Legal, Finance, Quality, and functional heads.
Coordinate 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, such as scale, presentation, and line changes, and enable feasibility and implementation with MSAT in alignment with product and corporate strategy.
Review technical documentation and summaries for sound rationale, regulatory conformance, consistency with existing approvals, and effectiveness in meeting their intended purpose.
Communicate manufacturing risk and strategy to the RZLT Management Team and Board of Directors as a pivotal source of information.

Benefits

Competitive compensation.
Stock options.
Health insurance (medical, dental, and vision).
Disability, life, and long-term care insurance.
Holiday pay.
Tracking Free Vacation Program.
401(k) plan match.
Educational assistance benefit.
Fitness center reimbursement.
Annual performance bonus eligibility, subject to the applicable plan and company and individual performance.