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Job Description

Since 1972, Takeda has had two sites in Italy for producing plasma-derived drugs in Rieti and Pisa, supporting patients with rare and complex diseases. These sites focus on the production of therapies derived from immunoglobulins, albumin, and coagulation factors. As a partner of the National Health System, we transform plasma into life-saving drugs under the “National Self-Sufficiency of Blood and its Products” program. We provide high-quality drugs worldwide, with a strong presence in Europe, America, and Asia.

OBJECTIVES/PURPOSE:

• Manage the activities related to 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 

ACCOUNTABILITIES:

• Manage and coordinate the Process Improvement team, ensuring that all team members are aligned with business objectives and operate efficiently

• Lead process improvement initiatives, monitoring, and stewardship

• Provide technical support about manufacturing processes, investigations, optimization, yield improvement projects, cycle time reduction, process robustness, Technology Transfer

• 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 submission / 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

DIMENSIONS AND ASPECTS - REQUIREMENTS:

Technical/Functional (Line) Expertise

• Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biotechnology, bioinformatics or pharma - process engineering

• 5/7 previous experience in Leadership Role

• Previous experience in plasma fractionation processes (Ideal - Preferred) or in biotechnology field > knowledge of proteins > Knowledge of 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

• 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 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

Decision-making and Autonomy

• 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

ADDITIONAL 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 (Law No. 68/99) will be considered a preferential qualification.

Important Considerations:

At Takeda, our patients rely on us to create quality products, and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wearing protective clothing.

• Need to remove all make-up, jewelry, contact lenses, nail polish,and/or artificial fingernails while in the manufacturing environment.

More About Us:

At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide.

Empowering our people to shine:

Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law.

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