Global Manufacturing Sciences BioProcess Lead (Sr. Manager)

Role Summary

Global Manufacturing Sciences Bioprocess Lead responsible for the manufacturing process for Takeda’s large and diverse commercial biologics portfolio. Acts as a senior subject matter expert across the biologics portfolio and provides technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. Ensures that complex, multi-site biologics drug substance processes are robust, well-controlled, and aligned across Takeda’s global network. A high-visibility role at the interface of development, manufacturing, and regulatory, where decisions shape how innovative biologics are reliably supplied to patients worldwide.

Responsibilities

• Provide upstream and downstream technical expertise and leadership across the biologics portfolio, including lifecycle initiatives to enable supply continuity, risk management, line extensions/discontinuations, tech transfers, global expansions/contractions, and regulatory activities.
• Ensure technical continuity of biologics drug substance manufacturing processes over time and across multiple manufacturing sites.
• Serve as a subject matter expert in commercial biologics drug substance processes, including mammalian cell culture and antibody production.
• Lead complex technical investigations and multi-site process improvement projects that span products, sites, and functions.
• Partner with site Manufacturing Sciences (MS) teams on process improvement and Life Cycle Management (LCM) projects.
• Collaborate with Biologics Process Development on process improvements and other LCM projects, providing technical input to translate development knowledge into commercial robustness.
• Shape and align CMC content for multi-site products, including authoring and reviewing regulatory filings and maintaining control strategy documents.
• Drive process knowledge sharing across sites to support consistent execution, strong control strategies, and effective LCM.
• Apply industry trends and innovation in bioprocessing to propose and implement practical process improvements and LCM initiatives.
• Represent Bio Process Sciences on cross-functional and product governance teams, influencing decisions and aligning on effective product lifecycle strategies.

Qualifications

• Required: Bachelor’s degree in Engineering, Life Sciences, or a related field with 10+ years of experience in pharmaceutical/biopharmaceutical development and/or manufacturing.
• Preferred: Advanced degree (MS or PhD).
• Technical experience in mammalian upstream and/or downstream drug substance process development, ideally with exposure to commercial-scale biologics manufacturing.
• Experience working in a global, matrixed organization, collaborating with multiple sites and cross-functional teams.
• Proven ability to analyze complex technical problems, interpret process and manufacturing data, and drive data-based decisions and solutions.
• Experience contributing to regulatory filings for biologics (e.g., CMC sections, control strategy documentation, or responses to health authority questions).
• Ability to lead cross-functional technical projects and to mentor or coach technical SMEs, even without direct line management responsibility.
• Strong interpersonal and communication skills, with the ability to influence and align diverse stakeholders in a cross-functional setting.
• Fluent in English (written and spoken); proficiency in Mandarin is an advantage but not required.

Skills

• Technical leadership in bioprocessing
• Regulatory affairs collaboration and CMC content development
• Process development and technology transfer
• Data-driven problem solving and decision making
• Cross-functional collaboration and stakeholder influence

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related field
• Advanced degree (MS or PhD) preferred

Additional Requirements

• Location: Zurich, Switzerland; Lexington, MA