CMC Lead, Lifecycle Management, Small Molecules Jūsō-honmachi, Ōsaka Category: Manufacturing Sciences

Job description

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To be notified when applications are available again, please share your contact information here. --> Skip to main content Job Posting Find jobs for Location Radius CMC Lead, Lifecycle Management, Small Molecules Jūsō-honmachi, Ōsaka Apply Now Job ID R0192097 Category Manufacturing Sciences Subcategory Manufacturing & Supply Business Unit Global Manufacturing & Supply Job Type Full time By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more <img class="js-hub-lazy hub-item__image" data-src="https://tbcdn.talentbrew.com/company/1113/v3_0/img/content/rc_biotech_site_covington_ga.jpg" src="https://tbcdn.talentbrew.com/company/3461/shared/img/transparent_1x1.png" width="800" height="