Senior Manager, Commercial Biologics Product Science Lead

Role Summary

Senior Manager, Commercial Biologics Product Science Lead is a senior subject matter expert role within Takeda’s Biologics Product Sciences team. The role provides technical leadership for regulatory interactions, including authoring CMC content for multi-site products, and helps shape CMC and program strategy to ensure robust control strategies for patients worldwide. Location: Lexington, MA / Zurich, Switzerland.

Responsibilities

• Build and maintain a comprehensive understanding of product structure, critical quality attributes, impurities, stability and structure‚Äìfunction 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‚ÄëGMP 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

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

Education

• Advanced degree (M.Sc. or PhD) is preferred.