Senior Manager, Commercial Manufacturing, Drug Substance
Revolution Medicines
Revolution Medicines seeks a Senior Manager, Commercial Manufacturing, Drug Substance to lead API manufacturing oversight across external partners. This role manages process validation, supply strategy, lifecycle activities, and cross-functional collaboration to ensure compliant, reliable commercial operations for small molecule drug substances.
Responsibilities
- Oversee commercial drug substance manufacturing including PPQ, CPV, and capacity planning activities
- Develop and execute manufacturing capacity strategies aligned with commercial demand forecasts
- Identify and mitigate manufacturing, supply, quality, compliance, and business risks
- Support CDMO selection, onboarding, technology transfer, and technical oversight at external sites
- Write, review, and approve technical documentation including protocols, reports, and regulatory submissions
Requirements
- Extensive experience in commercial pharmaceutical API manufacturing operations
- Strong knowledge of process validation, CPV, and regulatory compliance requirements
- Technical expertise in small molecule drug substance manufacturing
- Experience managing external manufacturing partners and CDMOs
- Cross-functional leadership and communication across quality, regulatory, and supply chain
- Demonstrated capability in process robustness, scale-up, and technology transfer
- Strategic planning and risk mitigation in supply chain management
Vacancy posted 5 days ago
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