CMC Lead, Lifecycle Management, Small Molecules

Posted 8 Hours Ago
Be an Early Applicant
Hiring Remotely in Osaka, JPN
Remote or Hybrid
Expert/Leader
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Leads CMC lifecycle management for commercial small-molecule products, coordinating cross-functional teams across pharmaceutical sciences, manufacturing, quality, supply, and technology organizations. Owns lifecycle strategies, post-approval changes, CMC decisions, issue resolution, manufacturing innovation, digital and data-driven initiatives, and launch-to-lifecycle transitions. Mentors team members and drives resource prioritization, operational robustness, and technology excellence across the portfolio.
Summary Generated by Built In

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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.

LocationsOsaka (Juso), Japan

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Skills Required

  • Bachelor's degree in engineering or life sciences
  • 8 to 12 years of experience in pharmaceutical development and manufacturing
  • Experience with post-approval lifecycle management
  • Experience operating in a global, matrixed organization
  • Experience defining and leading strategies and roadmaps for cross-functional initiatives
  • Strategic thinking and ability to prioritize effectively
  • Ability to build organizational capabilities and develop people
  • Ability to analyze and solve complex problems using innovative thinking, experience, and project management tools
  • Experience with manufacturing equipment, manufacturing processes, and digital technology for data-driven approaches

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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