CMC Lifecycle Management, Small Molecules

IRL - 1380 Takeda Pharmaceuticals Intl AG Ireland Branch

Dublin

On-site

EUR 100,000 - 138,000

Full time

4 days ago
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Job summary

Takeda is seeking an Associate Director, CMC Lead, LCM, Small Molecules, in Dublin to provide operational leadership for the CMC lifecycle management of commercial products within Takeda's small molecule portfolio. You will lead cross-functional GSQ CMC teams, shape lifecycle strategies, and contribute to innovation across manufacturing and digital analytics.

This role emphasizes collaboration across Global Product Teams and MSAT CMC Launch groups to ensure smooth transitions from launch to

Qualifications

  • Bachelor's degree in engineering or life sciences.
  • 8–12 years of pharma development and manufacturing experience, including post-approval lifecycle management.
  • Experience in a global, matrixed organization.
  • Experience defining and leading strategy/roadmap for cross-functional initiatives.
  • Strategic thinking with a patient-centric focus.
  • Ability to drive innovation in manufacturing equipment, processes, and digital/data-driven approaches.

Responsibilities

  • Lead cross-functional GSQ CMC teams to support lifecycle management activities.
  • Shape and drive robust lifecycle management strategies for commercial small molecule assets.
  • Serve as the CMC representative for assigned products within Global Product Teams.
  • Own key CMC decisions and coordinate with senior leadership on cross-portfolio impact.
  • Resolve complex CMC issues with cross-functional teams and escalate when needed.
  • Lead GSQ initiatives across internal and external sites to advance technology excellence and digital solutions.
  • Mentor CMC team members and build organizational capability.
  • Partner with MSAT CMC Launch group for smooth transition from launch to ongoing lifecycle management.

Skills

Leadership
Cross-functional collaboration
Strategic thinking
Project management
Data analytics

Education

Bachelor's degree in engineering or life sciences

Job description

About the role

As an Associate Director, CMC Lead, LCM, Small Molecules, you will provide operational and tactical leadership for the CMC lifecycle management of commercial products within Takeda's small molecule portfolio. You will act as a key CMC interface between Pharmaceutical Sciences, Global Supply & Quality (GSQ), and manufacturing technology organizations, supporting scientific excellence, sound lifecycle stewardship, and effective resource utilization across competing priorities. You will lead CMC teams responsible for the CMC content of commercial small molecule products, and help prioritize lifecycle management and technology excellence activities to optimize resource use across the portfolio.


How you will contribute


  • Lead cross-functional GSQ CMC teams to support lifecycle management activities.

  • Shape and drive the execution of robust lifecycle management strategies for Takeda's commercial small molecule assets.

  • Serve as the CMC representative for assigned products within Takeda's Global Product Teams under the guidance of senior CMC leadership.

  • Own key CMC decisions within your scope, making recommendations that directly influence lifecycle and supply outcomes, and escalating decisions with broad cross-portfolio impact.

  • Resolve complex CMC issues for assigned products, coordinating with cross-functional teams toward solutions and escalating enterprise-level issues to senior leadership with clear recommendations.

  • Lead initiatives across GSQ functions, including internal and external manufacturing sites, to advance robustness, technology excellence, and innovation, including digital solutions and data analytics.

  • Brings deep expertise in small molecule manufacturing, the regulatory environment, lifecycle management, post-approval changes, innovation trends, and financial fundamentals.

  • Partner with Project Managers to support the success of the CMC team.

  • Shape and recommend decisions regarding the ongoing lifecycle management of the marketed SM asset, exercising autonomy within defined scope.

  • Lead and oversee Lifecycle Management activities, coordinating SMEs across functional areas.

  • Drive alignment across the MSAT small molecule organization (including API and DP) to align LCM activities across GSQ functional organizations.

  • Partner with the MSAT CMC Launch group to ensure a smooth transition of products from launch into ongoing lifecycle management.

  • Mentor and develop CMC team members and contribute to building organizational capability.


What you bring to Takeda


  • A bachelor's degree in engineering or life sciences.

  • Minimum 8 to 12 years of experience in pharmaceutical development and manufacturing, including post-approval lifecycle management.

  • Demonstrated success operating in a global, matrixed organization preferred.

  • Experience defining and leading the strategy and roadmap for cross-functional initiatives.

  • Strategic thinking, with a focus on serving patients and building trust.

  • Creating an environment that inspires and enables people.

  • Focusing on key priorities and delivering strong results.

  • Building capabilities for now and the future.

  • Proven ability to analyze and solve complex problems through innovative thinking, experience, and project management tools.

  • Scope includes leading innovation in manufacturing equipment, manufacturing processes, and use of digital technology to enable data-driven approaches.


Locations

IRL - Dublin - Baggot Street


Base Salary Range

Base Salary Range: €100,000.00 - €137,500.00


Worker Details

Worker Type Employee Worker Sub-Type Regular Time Type Full time


About Takeda

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.


Takeda is an equal opportunity employer.


For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO).


If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.


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