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CMC Lead, Launch Product, Small Molecules

Takeda Pharmaceuticals

Title: CMC Lead, Launch Product, Small Molecules Location: Zurich, Switzerland (Primary) Location: Cambridge, MA (Secondary) About the role: As a CMC Lead, Launch Product, Small Molecules, you will provide strategic and operational leadership for the CMC execution and lifecycle management of a key launched product within Takeda’s small molecule portfolio. You will serve as the CMC Leader and primary interface between Pharmaceutical Sciences, Global Supply & Quality (GSQ), and manufacturing technology organizations, ensuring scientific excellence, robust lifecycle stewardship, and optimal resource utilization across competing priorities. You will build, develop, motivate and lead a global team of experts responsible for CMC content of a key launched product within the Takeda’s small molecule portfolio, and provide strong direction in prioritization of life‑cycle management and technology‑excellence activities to optimize resource utilization given competing requirements for key development small‑molecule programs. How will you contribute: Lead the cross‑functional GSQ CMC team to support effective product development activities with the Pharmaceutical Sciences Organization. Lead the GSQ CMC team to develop a robust life‑cycle management approach for Takeda’s key small‑molecule assets. Represent CMC matters within Takeda’s Global Product Teams. Provide strong leadership for initiatives which are complex or span across multiple products. Account for the scientific/CMC contents related to a small‑molecule asset, taking into consideration business impact on the GSQ organization. Lead the Small Molecules CMC team to effectively resolve issues relating to CMC matter, also at times with the Pharmaceutical Sciences organization. Work across all GSQ functions, including internal and external manufacturing sites, and Pharmaceutical Sciences to define directions related to robustness, technology excellence, innovation, digital solutions and data analytics. Account for key CMC decisions and provide recommendations that directly impact program outcomes. Have a deep and broad understanding of small‑molecule product development, manufacturing, the regulatory environment, lifecycle management, trends in innovation, and financial acumen. Influence broadly within the GSQ organization and Takeda Product Teams to drive decisions, alignment, and conflict resolution for complex cross‑functional CMC and technology‑excellence issues. Work closely with the PMs to drive success of the CMC team. Have full accountability for complex decisions regarding the development of the small‑molecule asset. Manage Life‑cycle Management activities and effectively coordinate SMEs from all functional areas to execute the decisions made. Collaborate with the Pharmaceutical Sciences organization and be accountable for decisions that impact commercialization of the key asset. Coordinate with the MSAT small‑molecule organization (including API and DP) to align CMC Development and LCM activities within various GSQ functional organizations. Align with MSAT global functions for business metrics and LCM procedures. Collaborate within MSAT small‑molecule (API and DP), Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for LCM activities. Work with the MSAT CMC LCM group on coordination of hand‑off of late‑stage products to the commercial team. What you bring to Takeda: A bachelor’s degree in engineering or life sciences. 10 to 15 years of experience in pharmaceutical development and manufacturing. Experience operating globally in a matrixed organization highly preferred. Experience defining strategy and roadmap for complex, cross‑functional initiatives. Strategic enterprise thinking, finding innovative ways to serve patients and build reputation and trust. Creating an environment that inspires and enables people. Focusing on the few priorities and delivering superior results. Elevating capabilities for now and the future. Capable of analyzing and solving complex problems through innovative thought and experience, as well as project‑management tools. Scope includes innovation in manufacturing equipment, manufacturing processes, and use of digital technology to provide data‑driven approaches. Locations CHE - Glattpark (Opfikon) - Zurich HQUSA - MA - Cambridge Worker Type Employee Worker Sub‑Type Regular Time Type Full time #J-18808-Ljbffr Takeda Pharmaceuticals

Vacancy posted 3 days ago
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