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

Overview

Senior Manager of Process Improvement & Stewardship – First Liters and Fractionation at Takeda. Join to apply for the Senior Manager of Process Improvement & Stewardship – First Liters and Fractionation role at Takeda. Takeda operates two plasma-derived drug production sites in Italy (Rieti and Pisa) and partners with the National Health System to transform plasma into life-saving drugs. Takeda is recognized as a Top Employer for its commitment to career development, inclusion, learning, sustainability, wellness, and values.

Location: ITA - Rieti. Worker Type: Employee. Worker Sub-Type: Regular. Time Type: Full time.

Note: This description includes responsibilities, qualifications, and information about Takeda. Takeda is an equal opportunity employer and values diversity and inclusion.

Responsibilities

• Manage the activities related to the Process Improvement & Stewardship Team
• Lead process improvement initiatives, monitoring, and stewardship
• Provide technical support about manufacturing processes, investigations, optimization, yield improvement projects, cycle time reduction
• Oversee product and process investigations, product impact assessment, risk assessment
• Collaborate with all other departments to ensure an integrated and cohesive approach
• Ensure compliance with regulations and quality standards, keeping Quality by Design documents up to date
• Manage process validation strategy
• Support the preparation of regulatory submissions / meetings
• Support regulatory inspections and defending 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

Qualifications / Requirements

• Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biotechnology, bioinformatics or pharma - process engineering
• 5/7 previous experience in a leadership role
• Previous experience in plasma fractionation processes (Ideal - Preferred) or in biotechnology field; knowledge of proteins; GMP/GDP (mandatory)
• Experience in Process Validation (Preferred)
• Experienced in process optimization, capable of implementing strategies to enhance productivity
• Proficient in continuous improvement processes
• Proven experience in statistics, data analysis or equivalent academic experience/course record
• Proven knowledge of six-sigma and DMAIC methodology
• Excellent knowledge of Italian and English, both written and spoken - Fluent level

Leadership and decision-making

• Focuses on the few priorities and delivers superior results
• Elevates the capabilities of the organization for now and the future
• Strategic enterprise thinking, finding innovative ways to serve patients and build reputation and trust
• Good understanding of industry, scientific trends and market conditions to develop solutions enhancing compliance and quality of life for patients
• Organizational skills
• Good communication and presentation skills as well as influencing skills
• Creating the environment that inspires and enables people
• Creates clarity, fostering alignment and accountability
• Is courageous in making decisions based on sound business judgment or appropriately escalate topics with high criticality

Travel and other information

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

What Takeda can offer you

We want our employees to succeed in everything they do — at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Health and Finance

• Health Care Assistance Insurance
• Employee Stock Purchase Plan
• Employee discount programs on commercial establishments, shops, medical services

Training and Development

• Technical skill training and professional development
• Job Rotation programs for working in other departments
• Spontaneous employee groups for awareness on Diversity, Equity, and Inclusion issues and community engagement activities
• Value-based culture

Individual Support

• Wellness programs
• On-site cafeteria and bar
• Resources for mental, physical, financial, and spiritual health
• Parental Leave

Note

• Belonging to protected categories will be considered as a preferential qualification.

Locations

• ITA - Rieti

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing
• Pharmaceutical Manufacturing