CMC Project Manager

Role Summary

As a CMC Project Manager, you will provide project management expertise to CMC LCM activities for Takeda’s small molecule portfolio. You will leverage technology platforms and processes to efficiently collect project data and deliver actionable project intelligence through effective use of visualization and reporting. You will also manage cross-functional teams in a highly matrixed environment to ensure successful completion of project goals. Location: Cambridge, MA (Hybrid).

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 effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process.
• Oversee knowledge, capability & improvement, tech transfer, and process validation.
• Use data-driven decision-making processes to enable timely and objective recommendations.
• Provide continuation, acceleration, reprioritization, and 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.
• 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.
• Grasp of organizational development and cross-functional group alignment.
• 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.
• Understanding of the drug development process and working knowledge of the essential activities for all key functional areas.

Qualifications

• BS in engineering, life sciences, or related field with a minimum 10 years experience, MS with a minimum of 8 years experience, or PhD with minimum 3 years experience 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.