Senior Manager, Commercial Biologics Product Science Lead

Role Summary

Join Takeda’s global Biologics Product Sciences team and become a member of the global team of product science experts responsible for product knowledge for Takeda’s large and diverse commercial biologics portfolio. In this role, you will be a senior subject matter expert across one or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. Through your deep product and process understanding you will shape CMC and program strategy and ensure robust control strategies to the benefit of patients worldwide.

Responsibilities

• Build and maintain a comprehensive understanding of product structure, critical quality attributes, impurities, stability and structure–function relationships.
• Define and justify product specifications using process and analytical history, ensuring consistency across sites and over the product lifecycle.
• Design and own analytical comparability strategies and non‑GMP analytical methods for assigned products.
• Lead preparation and review of CMC dossier sections related to product quality, characterization and analytical control strategy.
• Provide technical leadership for complex investigations and cross-site initiatives affecting product quality, driving alignment and timely decision-making.
• Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical Sciences, Global Manufacturing Sciences and Quality.
• Ensure effective product knowledge sharing across sites and functions to support reliable commercial supply.
• Influence stakeholders across functions and regions to resolve complex issues, balancing patient, quality, business and regulatory considerations.
• Mentor colleagues and contribute to the development of future talent in biologics product sciences.

Qualifications

• Degree in Engineering, Life Sciences, or closely related area
• B.Sc. with a minimum of 10 years of experience in a pharma/biotech environment; an advanced degree (M.Sc. or PhD) is preferred.
• Deep expertise in analytical methods and characterization for biologics with capability and interest in analyzing and solving complex problems through innovative thought and experience.
• Experience with activities associated with commercial launch and release as well as interactions with Health Authorities to support submissions.
• Experience operating globally in a matrixed organization would be greatly appreciated.
• Clear, concise communication skills, with the ability to convey complex concepts in writing and in person to technical and non-technical audiences.
• Fluent English required; proficiency in verbal and written Mandarin is beneficial but not required.
• Demonstrated enterprise mindset, strong prioritization and quality focus.

Education

• Degree in Engineering, Life Sciences, or closely related area
• Advanced degree (M.Sc. or PhD) preferred