Manager, CMC Drug Substance
Listed on 2026-09-18
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Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Validation Engineer
Why Sabin
Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.
DescriptionReports to
Senior Manager, CMC
LocationRemote work, US Only
Why SabinOur mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.
PositionSummary
The Manager, CMC Drug Substance provides technical leadership and expertise across Chemistry, Manufacturing, and Controls (CMC) activities supporting vaccine drug substance development. This role focuses on process development, characterization, technology transfer, and GMP manufacturing, supporting programs from late-stage clinical development through process validation, regulatory licensure, and commercialization.
The successful candidate will possess demonstrated experience leading technology transfers across process development and manufacturing environments, with hands‑on knowledge of vaccine manufacturing operations and viral vaccine platforms, including adenovirus‑vectored vaccines or comparable systems. The individual will provide technical leadership for drug substance development and manufacturing activities, partnering closely with internal teams, contract development and manufacturing organizations (CDMOs), and external stakeholders to support process scale‑up, validation, regulatory compliance, and commercial readiness.
Success in this role requires strong cross‑functional collaboration, sound scientific judgment, and a commitment to advancing vaccine access and global health impact.
Working closely with internal teams, contract development and manufacturing organizations (CDMOs), and external stakeholders, the Manager will drive project execution by coordinating technical activities, managing risks, and ensuring alignment with program objectives, timelines, and regulatory requirements. The role requires strong scientific and technical expertise, sound judgment, and the ability to work effectively across cross‑functional teams.
The Manager, CMC Drug Substance will collaborate across CMC, clinical, regulatory, quality, and global health functions to advance vaccine programs through critical development milestones. The ideal candidate combines technical leadership, intellectual curiosity, and a commitment to expanding equitable access to vaccines and improving global health outcomes.
Key Responsibilities- Support the planning, coordination, and execution of vaccine development programs from late‑stage clinical development through regulatory submission and commercial supply, partnering with cross‑functional scientific, analytical, regulatory, manufacturing, and global health stakeholders to achieve key milestones and timelines
- Support site selection and onboarding of a new Drug Substance Site
- Lead the tech transfer of a Phase 3 vaccine manufacturing process to external Drug Substance manufacturing partners, ensuring successful process scale‑up, validation, and commercial…
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