CMC Lead, Launch Product, Small Molecules
Takeda
About the role:
As a CMC Lead, Launch Product, Small Molecules, you will provide strategic and operational leadership for CMC execution and lifecycle management of a key launched small-molecule product. Serve as CMC leader and primary interface between Pharmaceutical Sciences, Global Supply & Quality (GSQ), and manufacturing technology organizations to ensure scientific excellence, robust lifecycle stewardship, and optimal resource utilization.
How will you contribute:
- Lead cross-functional GSQ CMC team to support product development with Pharmaceutical Sciences.
- Lead GSQ CMC team to develop robust lifecycle management for key small-molecule assets.
- Represent CMC matters within Global Product Teams.
- Provide leadership for complex, multi-product initiatives.
- Accountable for scientific/CMC content for a SM asset; consider business impact to GSQ.
- Resolve CMC issues across Small Molecules CMC team (and, when needed, with Pharmaceutical Sciences).
- Work across GSQ functions (including internal/external manufacturing sites) and Pharmaceutical Sciences to define robustness, technology excellence, and innovation (incl. digital solutions and data analytics).
- Accountable for key CMC decisions affecting program outcomes and for Life Cycle Management decisions.
- Influence and align across GSQ and Takeda Product Teams; drive conflict resolution.
- Coordinate hand-off of late-stage products to commercial team.
What you bring to Takeda:
- Bachelorโs degree in engineering or life sciences.
- 10โ15+ years experience in pharmaceutical development and manufacturing.
- Global, matrixed organization experience (preferred).
- Experience defining strategy/roadmap for complex, cross-functional initiatives.
- Strategic enterprise thinking; innovative problem-solving and project management capability.
Scope includes innovation in manufacturing equipment/processes and use of digital technology for data-driven approaches.
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