Global Manufacturing Sciences CMC Lead

Role Summary

Join us as our Global Manufacturing Sciences CMC Lead and drive high-impact, high-visibility CMC projects for innovative biologics in a dynamic global environment. You will provide technical and strategic leadership for Chemistry, Manufacturing and Controls (CMC) of one or more late-stage or commercial biopharmaceuticals with potential upside for the company. You will own the end-to-end CMC lifecycle for both Drug Substance and Drug Product, ensuring our manufacturing processes across multiple sites remain at the cutting edge of process technology. In this role, you will lead cross-functional CMC teams, represent Global Manufacturing Sciences (GMSci) in global product governance forums, and shape the CMC roadmap to support product launches, lifecycle management priorities, submissions, and continuous improvement aligned with Takeda’s manufacturing and supply strategy.

Responsibilities

• Set and own the CMC lifecycle management strategy and roadmap for assigned biologic products.
• Ensure manufacturing processes remain robust, performant, aligned with QbD principles, and comparable across multiple internal and external manufacturing sites.
• Lead cross-functional CMC teams to plan and execute short- and long-term CMC activities for product pre and post launch including, but not limited to, technology transfers, second generation processes, process improvements, post marketing commitments.
• Provide expert guidance and technical oversight for investigations, troubleshooting, process optimization, and major process or method changes.
• Be part of global product and governance teams, driving clear decisions on CMC strategy, lifecycle management and technology excellence.
• Drive preparation and support of CMC content for regulatory submissions (initial filings, market expansions, post-marketing changes, and regulatory commitments).
• Act as a subject matter expert in regulatory inspections and audits, ensuring consistent, science-based communication of product and process knowledge.
• Identify and lead implementation of innovation and continuous improvement initiatives – process improvements, new technologies, and data-driven approaches to reduce COGs and strengthen supply reliability.
• Collaborate closely with an assigned CMC Project Manager (who will provide you PM support).
• Continuous interaction with Process & Product Sciences, Analytical Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution across functions and sites.
• Mentor colleagues and contribute to building CMC expertise and best practices across the GMSci Biologics organization.

Qualifications

• Advanced degree (Master’s or higher preferred) in engineering or life sciences.
• At least 10 years of experience in pharmaceutical or biopharmaceutical development/manufacturing, with substantial exposure to biologics Drug Substance and Drug Product.
• Proven experience in product and process lifecycle management, including post-approval changes, technology transfers, and continuous improvement.
• Deep technical understanding of biologics manufacturing, quality, and regulatory frameworks, and how to apply these in CMC strategy and execution.
• Demonstrated ability to lead complex, cross-functional initiatives in a global, matrixed environment.
• Strong analytical and problem-solving skills, with a track record of making sound, data-based decisions on complex technical topics.
• Effective stakeholder management and communication skills, including experience interacting with senior leaders and health authorities.
• Fluency in English (spoken and written); Mandarin is an advantage but not required.
• Behaviours aligned with Takeda’s values enterprise and strategic thinking, focus on delivering results that matter for patients, ability to create an inclusive and empowering environment, and commitment to developing capabilities for the future.

Education

• Advanced degree (Master’s or higher preferred) in engineering or life sciences.