CMC Project Manager

Role Summary

CMC Project Manager role overseeing CMC LCM activities for Takeda’s small molecule portfolio. Manages cross-functional teams in a matrix environment and leverages technology to collect project data and deliver actionable insights through visualization and reporting.

Responsibilities

• Responsible for CMC project management of one or more small molecule products as co-lead with the CMC Lead; may also lead CMC sub teams for specific LCM projects.
• Responsible for CMC strategy execution to enable lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process knowledge, capability & improvement, tech transfer, and process validation.
• Use data-driven decision-making processes to enable timely and objective recommendations.
• 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.
• 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 dashboards using tools such as Power BI, Tableau, Excel, Power Apps, SharePoint, and Flow.
• Full accountability for decision making within approved budgets, timeline, and risk profiles and drives decision and approval for changes outside approved scope.
• Experience managing projects in a matrix environment.
• Co-leads CMC teams with functional areas from quality, process experts, product experts, device experts, and regulatory affairs.
• Works with supervisor for alignment on project management approach for more complex issues.
• Capture and disseminate clear, concise project information through global channels.

Qualifications

• BS in engineering, life sciences, or related field with a minimum of 10 years of experience; MS with at least 8 years; or PhD with at least 3 years in pharmaceutical development and manufacturing.
• Experience operating globally in a matrixed organization highly preferred.
• Experience leading cross-functional project teams.
• Expert knowledge of Microsoft tools (Excel, SharePoint, Power BI, Power Apps, Flow, etc.).
• Knowledge of leadership and project management methodologies (Agile, Lean, DMAIC, Waterfall, and/or PMBOK).
• Ability to create a project management environment that fosters a patient-focused entrepreneurial mindset.

Skills

• Project management in a matrix environment
• Data visualization and reporting
• Agile and Lean methodologies
• Process improvement and tech transfer
• Cross-functional collaboration and stakeholder management

Education

• BS in engineering, life sciences, or related field (required); advanced degree preferred

Additional Requirements

• Location: Cambridge, MA (Hybrid)