Process Analytical Technology

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**:
You will ensure real-time monitoring of production processes through the implementation and management of in-line, on-line and at-line analytical technologies. The role also requires integrating data analysis skills to optimize process performance and support evidence-based decision-making.

**How you will contribute**:

- Lead the development and research of PAT solutions by studying and implementing in-line, on-line and at-line probes (such as NIR, Raman, FTIR spectroscopy, pH sensors, conductivity, turbidity, flow rate, flow imaging, DLS, particle counting) to monitor and inspect production processes in real-time.
- Conduct feasibility studies for analytical methods using in-line, online, and at-line instruments.
- Ensure accurate data collection and analysis to optimize production processes.
- Collaborate with cross-functional teams, to develop monitoring solutions aligning with industry standards and regulations.
- Support in-line PAT instruments qualification (IQ/OQ/PQ) and related documentation writing
- Support and execute controlled research experiments and trials
- Manage and perform scientific research, development, and testing of new Process Analytical technologies for continuous process monitoring.
- Stay updated on emerging technologies in sensoristics and biotech.
- Execute manufacturing runs and scale-down experiments participating in their design and execution
- Prepare and present comprehensive technical and/or project reports and formal presentations to a full range of internal / external audiences.

**What you bring to Takeda**:

- PhD or Master Degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Bio-Chemical Engineering )
- At least 2-3 years of relevant University/Industry experience (pharmaceutical, chemical, biotech) in Process Analytical Technology for development of probes to characterize protein material.
- Profound knowledge in in-line process analytical technology and proteins.
- Mandatory: proficiency in protein characterization techniques, including but not limited to optical methods
- Preferrable: Knowledge in biochemistry, protein purification and engineering principles
- Preferrable: expertise in analytical chemistry methodologies to support the analysis and characterization of protein-based therapeutics
- Basic understanding of relevant manufacturing processes
- Knowledge of statistics and main statistical analysis tools (Minitab, etc.)
- Fluent English and Italian and good redaction skills

**What Takeda can offer**:
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.
- Willingness to travel to various internal/external Takeda meetings and events
- Flexibility to work in shifts

**More About Us**:
At Takeda, we are transforming patient care through the