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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.
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.
Bachelor’s degree in Engineering, Life Sciences, or a related field with 10+ years of experience in pharmaceutical/biopharmaceutical development and/or manufacturing; an advanced degree (MS or PhD) is preferred.
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.
CHE - Glattpark (Opfikon) - Zurich HQUSA - MA - Lexington
Employee
Regular
Full time
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