Senior Manager, Commercial Biologics Product Science Lead

Senior Manager, Commercial Biologics Product Science Lead

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.

How you will contribute:

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

What you bring to Takeda:

• 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.

Locations:

Lexington, MA

Vienna, Austria