VP, Manufacturing

Lead all drug product manufacturing and packaging operations from late-stage development through commercial launch and ongoing commercial supply, while overseeing process validation, PPQ, and commercial technology transfer to commercial manufacturing sites. Provide oversight and technical guidance for early-stage drug product process development, ensuring scalable, robust, and well-controlled processes, and drive CDMO selection, contracting, and governance, ensuring strong technical performance, quality, and supply reliability. Ensure manufacturing and packaging operations meet GMP compliance, process robustness, and global regulatory expectations. Author and review manufacturing-related CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and container–closure documentation. Lead technical interactions with regulatory authorities, including preparing briefing materials, responding to inquiries, and representing manufacturing during regulatory meetings. Support preparation and readiness for pre-approval inspections (PAIs), including technical documentation, training, and site responses. Partner with Quality to support technical investigations, root-cause analyses, and CAPA development. Contribute to process lifecycle management, including post-approval changes, continued process verification (CPV), and ongoing optimization. Partner with Supply Chain on launch readiness, production planning, technical supply risk assessment, and commercial supply continuity. Build, mentor, and lead a high-performing team supporting manufacturing, packaging, and technical operations.