About The Position
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.
Requirements
- 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.
Nice To Haves
- an advanced degree (MS or PhD) is preferred.
- proficiency in Mandarin is an advantage but not required.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
