CMC Lead, Lifecycle Management, Small Molecues

IRL - 1380 Takeda Pharmaceuticals Intl AG Ireland Branch; Dublin; On-site; EUR 100,000 - 138,000; Full time

Job summary

Takeda Dublin is seeking an Associate Director, CMC Lead, LCM for small molecules to provide leadership for the CMC lifecycle management of commercial products. You will oversee cross-functional GSQ teams, shape lifecycle strategies, and ensure robust execution across the portfolio.

As CMC representative for assigned products within Global Product Teams, you will own key decisions, coordinate with internal and external manufacturing sites, advance technology and data analytics, and mentor the

Qualifications

• Bachelor's degree in engineering or life sciences.
• 8–12 years of experience in pharmaceutical development and manufacturing, including post-approval lifecycle management.
• Experience in a global, matrixed organization; ability to define strategy and roadmaps for cross-functional initiatives.
• Strong strategic thinking, patient focus, and leadership capabilities.
• Experience with manufacturing equipment, processes, and data-driven digital technology.

Responsibilities

• Lead cross-functional GSQ CMC teams to support lifecycle management activities.
• Shape and drive 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.
• Own key CMC decisions and coordinate with cross-functional teams to resolve issues.

Skills

Cross-functional leadership

CMC knowledge

Strategic thinking

Project management

Education

Bachelor's degree in engineering or life sciences

Job description

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 will you 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. Bring 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

€100,000.00 - €137,500.00

Worker Type

Employee. 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.

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