Vice President, Global Manufacturing

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $290k - $340k / year

⏰ Full Time

🔴 Lead

👔 Vice President

👻 Ghost score 0%

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Rezolute, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $96.9M Post-IPO Equity - Rezolute on 2025-04

Healthcare • Biotechnology • Pharmaceuticals

Rezolute, Inc. is a biopharmaceutical company focused on developing and delivering novel therapies for rare metabolic disorders, specifically hyperinsulinism. The company’s lead program, ersodetug, has two Phase 3 programs targeting congenital and tumor hyperinsulinism, and Rezolute conducts clinical trials, investigator-initiated studies, and publishes clinical outcomes. Rezolute also engages with patients, investors, and the medical community to improve care and quality of life for affected patients and families.

📋 Description

• Provide vision, leadership, strategy and management for Rezolute’s fully externalized global biologics manufacturing network from cell line through Drug Product. • Oversee reliable, robust and redundant manufacture of ersodetug for late-phase clinical supply, global submissions, approval, launch and continuous commercial supply. • Build and lead executive relationships with global service providers at Site Head and above-site leadership levels. • Design and implement the transition from clinically oriented manufacturing operations to a robust commercial manufacturing network. • Oversee cell line development, cell bank manufacture and maintenance, Drug Substance manufacture, and aseptic fill-finish Drug Product manufacture. • Manage storage and depot facilities supporting the manufacturing network. • Own the Manufacturing Plan, translating the consensus supply plan into campaign schedules, capacity reservations, slot commitments and critical materials plans. • Develop and execute global manufacturing network, redundancy, second-source, dual-site and business continuity strategies. • Establish and manage service provider performance against Right First Time and On Time In Full expectations through KPIs, performance reviews and corrective action. • Identify and mitigate manufacturing and supply risks. • Build and lead a Manufacturing Technical team supporting routine manufacture, technical monitoring, batch record and process performance review, and deviation and investigation resolution. • Lead site transfers through registration and manage service provider programs, contracts and deliverables. • Support global submissions and pre-approval inspection readiness with Quality and Regulatory teams. • Build and develop 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 service provider oversight and performance management. • Partner with Quality on batch disposition, deviations, change control, supplier qualification, audits, inspection readiness and registrational compliance. • Partner with Global Supply Chain on Drug Product handoff and alignment between manufacturing and supply plans. • Manage 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 selection and oversight of service providers and critical material suppliers. • Identify product lifecycle needs and review technical documentation for regulatory conformance and effectiveness.

🎯 Requirements

• 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. • 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%). • Experience with multiple CDMO networks across the US, EU and Asia preferred. • Board- and executive-level communication of manufacturing risk and strategy preferred.

🏖️ Benefits

• Annual performance bonus • Competitive compensation • Stock options • Health Insurance (Medical / Dental / Vision)

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