Global Manufacturing Sciences CMC Lead

Role Summary

Global Manufacturing Sciences CMC Lead drives high-impact, high-visibility CMC projects for innovative biologics in a dynamic global environment. You will own the end-to-end CMC lifecycle for Drug Substance and Drug Product across multiple sites, lead cross-functional CMC teams, and shape the CMC roadmap to support product launches, lifecycle management, submissions, and continuous improvement aligned with Takeda’s manufacturing and supply strategy. Location: USA - MA - Hayden.

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 technology transfers, second generation processes, process improvements, and 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 ‚Äì 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 PM support).
• Maintain 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‚Äôs 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 values focused on delivering results for patients, inclusivity, and capability development for the future.

Skills

• CMC strategy and lifecycle management
• Cross-functional project leadership
• Biologics Drug Substance and Drug Product knowledge
• Regulatory submissions and inspections
• Process development and technology transfer
• Quality by Design (QbD) principles
• Data-driven decision making and problem solving
• Stakeholder management and senior leadership communication

Education

• Master‚Äôs degree or higher in engineering or life sciences (preferred).

Additional Requirements

• Location: USA - MA - Hayden