CMC Project Manager

Role Summary

CMC Project Manager responsible for providing project management expertise to CMC LCM activities for Takeda’s small molecule portfolio. Lead cross-functional teams in a matrixed environment to ensure successful completion of project goals, leveraging technology to collect project data and deliver actionable project intelligence.

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 knowledge, capability & improvement, 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.
• 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, 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 area.

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).
• Create a project management environment that fosters a patient-focused entrepreneurial mindset.

Skills

• Project management in a matrix environment
• Data visualization and dashboard development (Power BI, Tableau, Excel, Power Apps, SharePoint, Flow)
• Agile, Lean, DMAIC, Waterfall, PMBOK methodologies
• Cross-functional team leadership and collaboration
• Strong analytical and problem-solving abilities
• Effective communication of project information globally

Education

• BS/MS/PhD in engineering, life sciences, or related field as specified in qualifications