Formulation and Filling Lead

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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.

Across Italy and the world, Takeda is recognized as a Top Employer by the Top Employers Institute based on our commitment to career development, inclusion, learning, sustainability, wellness, and, most importantly, our values.

Join us to make a difference.

About the Role:

As the Formulation and Filling Lead, you will supervise know the activities of competence, which is coordinated and controlled through the guidance of the Formulation and Filling Shift leaders. You will guarantee activities are carried out in compliance with clear and defined operating procedures in order to ensure that the process/product is performed and manufactured according to equally defined qualitative criteria.

How you will contribute:

• Ensure compliance with EHS regulations in working hours during the activities leads and controls

• Responsible for respecting the coverage of production volumes planned by the Supply Chain

• Guarantee continuous improvement related to production aspects and team

• Coordinate Production activities (Albumin Formulation and Filling) according to the reference

• Organize the qualification operations of Production personnel (5%)

• Participate in the management of the review of procedures, training, activities related to the opening and investigation of events, validations and Change Controls in Production (10%)

• Meet the expected production targets in terms of process times, communicating any delays and modifying the production plan accordingly (15%)

• Coordinate production personnel and plan their activities in order to comply with the production plan and carry out trainings; evaluate the performance of their own reports (15%)

• Responsible for network interactions and global programs related to Albumin Production

• Organize and plan all the production activities independently, based on the production plan

• Manage the reporting staff independently, assessing their performance and ensuring proper training

• Coordinate with the other reference functions in order to achieve the goal or solve problems

• Investigate the issues occurred during the Albumin production process and decide the actions to be taken to solve them (such as communication to the higher level)

What you bring to Takeda:

• Bachelor’s / Master's degree in chemistry, pharmaceutical chemistry, biology, engineering

• Knowledge of cGMP

• Experience in sterility environment, filling of sterile under isolators.

• Previous experience of at least three/five years in the pharmaceutical field ad Formulation and Filling Lead

• Previous experience of at least 10 years in the pharmaceutical/chemical sector in Manufacturing area.

• Knowledge of the main leadership behaviors

• Communication and presentation skills

• Excellent knowledge of English and Italian

• Availability of 5% of the time to travel

• Knowledge of the Albumin formulation and sterile filling process

• Ability to interpret and modify the production plan

• Knowledge of MBR and Production SOPs

• Orientation to results, always acting in accordance with Takeda PTRB

• Ability to manage a team and changes

• Ability to positively influence and motivate the team, communicating effectively and in alignment with business requirements, Safety, Quality and company objectives

• Have an enterprising mindset, finding innovative ways to serve patients, build trust, reputation and business.

• Ability to create a positive and collaborative environment that incentivizes the team to work together effectively.

• Focused on priorities, lead the team on achieving goals with constant alignment.

• Recognize the potential of people and take the time to develop skills to increase performance.

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.

• The position is configured as “Person in charge” for safety aspects according to Italian legislation (Article 2 paragraph 1 letter and Legislative Decree 81/2008)

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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