CMC Lead, Lifecycle Management, Small Molecules

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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.
• 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.

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

Locations

Osaka (Juso), Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time