Process Analytical Technology (PAT) Specialist
Join to apply for the Process Analytical Technology (PAT) Specialist role at TAKEDA PHARMACEUTICALS AMERICA, INC.
Location: Rieti, Italy
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. We transform plasma into life-saving drugs under the “National Self-Sufficiency of Blood and its Products” program and provide high-quality drugs worldwide with a strong presence in Europe, America, and Asia. Takeda is recognized as a Top Employer by the Top Employers Institute for commitment to career development, inclusion, learning, sustainability, wellness, and our values. Join us to make a difference.
About The Role
We are looking for a candidate with expertise in Process Analytical Technology (PAT) applied to continuous monitoring in biotechnology production processes. You will be responsible for searching, testing, and implementing innovative solutions aimed at improving monitoring and optimization across our production processes. 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
* Preferable: knowledge in biochemistry, protein purification and engineering principles
* Preferable: 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
* Health Care Assistance Insurance
* Employee Stock Purchase Plan
* Employee discount programs on commercial establishments, shops, medical services
Important Considerations
* At Takeda, our patients rely on us to create quality products, and 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.
* 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
Note
* Belonging to protected categories (Law No. 68/99) will be considered a preferential qualification.
Legal/Policy
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Locations
* ITA - Rieti
Employment Type
* Full-time
Note: This description reflects information current at posting date and may be updated.
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