Senior Manager of Process Improvement & Stewardship – First Liters and Fractionation

Overview

Senior Manager of Process Improvement & Stewardship – First Liters and Fractionation at Takeda Pharmaceutical (Italy).

Responsibilities

• Manage the activities related to the Process Improvement & Stewardship Team, ensuring alignment with business objectives and efficient operation.
• Lead process improvement initiatives, monitoring, and stewardship.
• Provide technical support about manufacturing processes, investigations, optimization, yield improvement projects, and cycle time reduction; ensure process robustness and Technology Transfer where applicable.
• Oversee product and process investigations, product impact assessment, and risk assessment.
• Collaborate with all departments to ensure an integrated and cohesive approach.
• Ensure compliance with regulations and quality standards; keep Quality by Design documents up to date.
• Manage process validation strategy.
• Support the preparation of regulatory submissions/meetings and regulatory inspections; defend technical decisions to regulatory agencies.

Core Elements Related to this Role

• Excellent leadership and team management skills.
• Strong strategic orientation and analytical thinking ability.
• Excellent communication, collaboration, and influencing skills.
• Experience in managing complex projects and implementing innovative technologies.
• Ability to anticipate changes and solve complex problems.
• Project management skills and results orientation.
• Development of the team, providing strategic direction and support in complex scenarios.
• Development of strategic plans for departmental growth and operational efficiency.

Technical/Functional Requirements

• Master or PhD degree in technical/scientific fields (preferably pharmaceutical sciences, chemistry, biotechnology, bioinformatics or pharma-process engineering).
• 5/7 years of leadership experience.
• Previous experience in plasma fractionation processes (ideal) or biotechnology; knowledge of proteins; mandatory GMP/GDP.
• Experience in Process Validation (Preferred).
• Experience in process optimization and implementing productivity-enhancing strategies.
• Proficiency in continuous improvement processes.
• Proven experience in statistics/data analysis or equivalent academic experience.
• Proven knowledge of Six Sigma and DMAIC methodology.
• Fluent in Italian and English (written and spoken).

Leadership & Decision-Making

• Focus on priorities and deliver superior results.
• Elevate organizational capabilities for now and the future.
• Strategic thinking to serve patients and build trust; understand industry trends and market conditions.
• Strong organizational, communication, presentation, and influencing skills.
• Ability to create clarity, foster alignment, and make or escalate decisions with sound business judgment.

Additional Information

• Willingness to travel to internal/external Takeda meetings and events.

What Takeda Can Offer

We provide world-class benefits and resources to support employees in work, home, and community life.

• Health and Finance
  • Health Care Assistance Insurance
  • Employee Stock Purchase Plan
  • Employee discount programs on goods and services
• Training and Development
  • Technical skill training and professional development
  • Job rotation programs
  • Diversity, Equity, and Inclusion initiatives
• Individual Support
  • Wellness programs
  • On-site cafeteria and facilities
  • Resources for mental, physical, financial, and spiritual health
• Note
  • Belonging to protected categories will be considered a preferential qualification.

Important Considerations

In this role you may work in a controlled manufacturing environment requiring gowning and protective clothing; removal of makeup, jewelry, contact lenses, nail polish, or artificial nails may be required while in the manufacturing environment.

More About Us

Takeda is a patient-focused company committed to quality, safety, and excellence. We value diversity and provide equal employment opportunities to all applicants.

Locations

ITA - Rieti

Worker Type

Employee