Vice President, Global Manufacturing

Rezolute•Redwood City, CA

1d•$290,000 - $340,000•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. The position 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. It serves as a key source of information for the RZLT Management Team and Board of Directors. The position may be performed remotely within the US. The role will transition clinically oriented manufacturing operations into a reliable, redundant network that can support global markets while retaining operational agility and establishing the rigor needed to meet market demand. It oversees externalized manufacturing, storage, and depot facilities across qualified service providers, including cell line development, cell bank manufacture and maintenance, Drug Substance manufacture, and aseptic Drug Product fill-finish. The role owns the Manufacturing Plan derived from the Global Supply Chain-led S&OP process, manages manufacturing performance and risks, develops network redundancy and continuity strategies, and builds the team, systems, governance, provider relationships, and agreements needed to support late-stage development and commercial supply. The Vice President partners with Quality, MSAT, Regulatory, Global Supply Chain, Legal, Finance, and other functional leaders on quality and compliance, submissions and inspection readiness, supply planning, provider selection and oversight, financial management, and product lifecycle needs. The position may require morning, evening, and/or weekend commitments because the team is distributed across the US and service providers are offshore. Domestic and international travel of up to 50% is required.

Requirements

Bachelor of Science in Engineering, Life Sciences, or a related field is required.
15 or more years of biologics manufacturing experience within biotech or biopharmaceutical organizations.
Five to seven or more 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 setting.
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, resulting in resolution of capacity, capability, and reliability issues.
Demonstrated experience establishing biologics manufacturing redundancy, second-source, or dual-site supply.
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.
Availability for possible morning, evening, and/or weekend commitments due to a US-distributed team and offshore service providers.
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, and redundant commercial manufacturing network for 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 across qualified global service providers.
Oversee storage and depot facilities supporting the manufacturing network, including cell banks, Drug Substance, and Drug Product held at manufacturing sites; Drug Product accountability transfers to Global Supply Chain when it ships from the manufacturing site.
Manage manufacturing elements of the current Plan of Record, including Drug Substance and Drug Product for two advanced P3 programs preparing for potential global launches.
Own the Manufacturing Plan derived from the Global Supply Chain-led S&OP process; translate consensus supply plans 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 relationships with service providers at Site Head and above-site levels to influence priority, capacity, and investment, and resolve capability, reliability, and readiness issues.
Establish tiered service-provider governance across operational, site leadership, and executive steering levels, with clear work, cost, risk, deliverable, and escalation expectations.
Develop and execute the global manufacturing network strategy, including redundancy, second-source and dual-site strategies, business continuity plans, and long-term manufacturing solutions.
Establish and manage service-provider performance against Right First Time and On Time In Full expectations through KPIs, routine reviews, and corrective actions.
Identify and mitigate risks to Drug Substance and Drug Product manufacture and supply, implementing mitigation plans and escalating risks as appropriate.
Build and lead 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 for deviations and investigations at service providers.
Build redundant and reliable manufacturing capabilities and enable site transfers through registration by establishing provider relationships and managing programs, contracts, and deliverables.
Partner with the MSAT team within Quality on technical specifications, characterization, qualification and validation, and Module 3 authorship.
Lead cross-functional resolution of deviations, investigations, and CAPAs with Quality, MSAT, and Technical Operations Leadership to enable reliable, on-time supply.
Support global submissions and pre-approval inspection readiness at service providers in partnership with Quality and Regulatory teams.
Collaborate openly and effectively as part of the broader Technical Operations Leadership team.
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 work.
Develop phase-appropriate manufacturing systems, procedures, and governance for service-provider oversight, manufacturing planning, performance management, and executive escalation.
Work with the Head of Quality on batch disposition support, deviations 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 FDP supply plan.
Manage manufacturing financial matters, including contracts, budgeting, forecasting, long-range planning, capacity commitments, and Cost of Goods for Drug Substance and Drug Product.
Lead service-provider relationship development and contracting, including master services, supply, capacity reservation, and technical agreements; ensure agreements 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 for 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 their feasibility and implementation with MSAT and product and corporate strategy.
Review technical documentation and summaries for sound rationale, regulatory and approval conformance, and effectiveness in achieving their intended purpose.

Benefits

Competitive compensation.
Stock options.
Medical, dental, and vision insurance.
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.