Global Manufacturing Sciences BioProcess Lead (Sr. Manager)

<p>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s <a href="https://jobs.takeda.com/privacynotice" target="_blank">Privacy Notice</a> and <a href="https://www.takeda.com/terms-and-conditions/" target="_blank">Terms of Use</a>.  I further attest that all information I submit in my employment application is true to the best of my knowledge.</p><p></p><p style="text-align:inherit"></p><h2><b>Job Description</b></h2><p style="text-align:inherit"></p><h1>Title: Global Manufacturing Sciences BioProcess Lead (Sr. Manager)</h1><h1>Location: Zurich, Switzerland / Lexington, MA</h1><p></p><h1><b>About the role:</b></h1><p>As a Global Manufacturing Sciences Bioprocess Lead, you will be an expert responsible for the manufacturing process for Takeda’s large and diverse commercial biologics portfolio. You will act as a senior subject matter expert across the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. You will ensure that complex, multi-site biologics drug substance processes are robust, well-controlled, and aligned across Takeda’s global network. This is a high‑visibility role at the interface of development, manufacturing, and regulatory, where your decisions directly shape how innovative biologics are reliably supplied to patients worldwide.</p><p></p><h1><b>How will you contribute:</b></h1><ul><li><p>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.</p></li><li><p>Ensure technical continuity of biologics drug substance manufacturing processes over time and across multiple manufacturing sites.</p></li><li><p>Serve as a subject matter expert in commercial biologics drug substance processes, including mammalian cell culture and antibody production.</p></li><li><p>Lead complex technical investigations and multi-site process improvement projects that span products, sites, and functions.</p></li><li><p>Partner with site Manufacturing Sciences (MS) teams on process improvement and Life Cycle Management (LCM) projects.</p></li><li><p>Collaborate with Biologics Process Development on process improvements and other LCM projects, providing technical input to translate development knowledge into commercial robustness.</p></li><li><p>Shape and align CMC content for multi-site products, including authoring and reviewing regulatory filings and maintaining control strategy documents.</p></li><li><p>Drive process knowledge sharing across sites to support consistent execution, strong control strategies, and effective LCM.</p></li><li><p>Apply industry trends and innovation in bioprocessing to propose and implement practical process improvements and LCM initiatives.</p></li><li><p>Represent Bio Process Sciences on cross-functional and product governance teams, influencing decisions and aligning on effective product lifecycle strategies.</p></li></ul><p></p><h1><b>What you bring to Takeda:</b></h1><ul><li><p>Bachelor’s degree in Engineering, Life Sciences, or a related field with 10&#43; years of experience in pharmaceutical/biopharmaceutical development and/or manufacturing; an advanced degree (MS or PhD) is preferred.</p></li><li><p>Technical experience in mammalian upstream and/or downstream drug substance process development, ideally with exposure to commercial-scale biologics manufacturing.</p></li><li><p>Experience working in a global, matrixed organization, collaborating with multiple sites and cross-functional teams.</p></li><li><p>Proven ability to analyze complex technical problems, interpret process and manufacturing data, and drive data-based decisions and solutions.</p></li><li><p>Experience contributing to regulatory filings for biologics (e.g., CMC sections, control strategy documentation, or responses to health authority questions).</p></li><li><p>Ability to lead cross-functional technical projects and to mentor or coach technical SMEs, even without direct line management responsibility.</p></li><li><p>Strong interpersonal and communication skills, with the ability to influence and align diverse stakeholders in a cross-functional setting.</p></li><li><p>Fluent in English (written and spoken); proficiency in Mandarin is an advantage but not required.</p></li></ul><p style="text-align:inherit"></p><h2><b>Locations</b></h2>Zurich, SwitzerlandUSA - MA - Lexington<p style="text-align:inherit"></p><h2><b>Worker Type</b></h2>Employee<p style="text-align:inherit"></p><h2><b>Worker Sub-Type</b></h2>Regular<p style="text-align:inherit"></p><h2><b>Time Type</b></h2>Full time