CMC Lead, Launch Product, Small Molecules

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 you will also 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 program.

• Lead the cross functional GSQ CMC team to support effective product development activities with Pharmaceutical Sciences Organization.
• Lead the GSQ CMC team to develop a robust life cycle management 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.
• Accountable for the scientific/CMC contents related to a SM asset, taking into consideration the business impact to the GSQ organization.
• Lead the Small Molecules CMC team to effectively resolve issues relating to CMC matters, also at times with the Pharmaceutical Sciences organization, when needed.
• Work across all GSQ functions, including internal and external manufacturing sites, and Pharmaceutical Sciences to define directions related to robustness technology excellence and innovation including digital solutions and data analytics.
• Accountable for key CMC decisions and provide recommendations to have a direct impact on program's outcome.
• Have a deep and broad understanding of small molecule product development, manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen.
• Influence broadly within 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 the success of the CMC team.
• Full accountability for complex decisions regarding the development of the SM asset.
• Accountable for the decision relating to Life Cycle Management activities, and able to effectively manage SMEs from all functional areas to execute the decisions made.
• Work alongside Pharmaceutical Sciences organization and influence and be accountable for decisions made having impact to the commercialization of the key asset.
• Work across MSAT small molecule organization (including API and DP) to align CMC Development and LCM activities within the various GSQ functional organizations.
• Work across MSAT global functions as needed for business metrics and align on LCM procedures.
• Work across 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.

• A bachelor degree in engineering or life sciences.
• Minimum 10 to 15 years experience in pharmaceutical development and manufacturing.
• Experience operating globally in a matrixed organization highly preferred.
• Experience defining the strategy and roadmap for complex, cross-functional initiatives.
• Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating the environment that inspires and enables people.
• Focusing on the few priorities and provide 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.

IRL - Dublin - Baggot Street
IND - Bengaluru

Employee

Regular

Full time