非公開
Job Description
・Provide project management expertise to CMC LCM activities for Takeda’s product portfolio
・Leverage technology platforms and processes to efficiently collect project data and deliver actionable project intelligence through effective use of visualization and reporting
・Manages cross-functional teams in a highly matrixed environment to ensure successful completion of project goals
ACCOUNTABILITIES
・Responsible for CMC project management of one or more small molecules APIs as co-lead with the CMC Lead; may also lead CMC subteams for specific LCM projects
・Responsible for CMC strategy execution to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process knowledge, tech transfer, and process validation
・Use data-driven decision-making processes to enable timely and objective recommendations for continuation, acceleration, reprioritization, redesign of the development plan.
・Accountable for creating cross-functional plans, budgets, and resource estimates, to drive successful and timely project completions
・Use agile principles to reduce process complexity and increase organizational capacity
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
・Ability to analyze unstructured problems, identify root causes and align team objectives to drive business goals
・Knowledge of Project Management and Process Improvement methodologies (Agile, Lean, DMAIC, Waterfall, SPOT, and/or PMBOK)
・Understanding of the drug development process and working knowledge of the essential CMC activities
・Experience capturing and translating business requirements into technical solutions
・Experience building interactive dashboard using tools such as Power BI, Excel, Power Apps, SharePoint, Microsoft Teams and Flow
Leadership
・Experience managing projects in a matrix environment
・Inspires others to share their vision and support them to reach a common goal
・A firm grasp of organizational development and cross-functional group alignment
Aptitude in building a patient-centered best in class organization
Decision-making and Autonomy
・Accountability for decision making within approved budgets, timeline, and risk profiles and drives decision and approval for changes outside approved scope
Interaction
・Co-leads CMC teams with functional areas from quality, process experts, product experts, device experts, and regulatory affairs
・Works across functional area boundaries and sites when needed to bring in additional resources and alignment
・Works with supervisor for alignment on project management approach for more complex issues
Innovation
・Capture and disseminate clear, concise project information through global channels
・Understanding of the drug development process and working knowledge of the essential activities for all key functional area
Complexity
・Demonstrates initiative, sound judgment and flexibility
・Possesses effective time management and organizational skills
・Be able to work under deadlines and on multiple projects simultaneously
・部門内外あるいは国内外の別拠点等、入社後も社内公募で様々なキャリアの方向性が選べます。
・幅広い製品、技術分野に携われ、経験を拡張できる（無菌、原薬、固形、注射、ワクチン など）。
当社程の製品群ならびに開発～生産まで全工程を同一拠点にて行っている企業は珍しい。