Overview
Process Analytical Technology (PAT) Specialist at Takeda. We are looking for a candidate with expertise in PAT applied to continuous monitoring in biotechnology production processes. The role involves searching, testing, and implementing innovative solutions to improve monitoring and optimization across production processes, with a focus on real-time monitoring and data-driven decision making.
About the Role
We require expertise in Process Analytical Technology (PAT) for continuous monitoring in biotechnology production. You will be responsible for searching, testing, and implementing solutions to improve monitoring and optimization across production processes. You will ensure real-time monitoring through in-line, on-line and at-line analytical technologies and integrate data analysis to optimize process performance and support evidence-based decision-making.
Responsibilities
* 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 instrument 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 internal and 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 PAT for development of probes to characterize protein material.
* Profound knowledge in inline process analytical technology and proteins.
* Mandatory proficiency in protein characterization techniques, including 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 (e.g., Minitab).
* Fluent English and Italian with good redaction skills.
What Takeda can offer
* Health Care Assistance Insurance
* Employee Stock Purchase Plan
* Employee discount programs on commercial establishments and medical services
* Technical skill training and professional development
* Job rotation programs for working in other departments
* Diversity, Equity, and Inclusion initiatives and community engagement activities
* Value-based culture
* Wellness programs; on-site cafeteria and bar; resources for mental, physical, financial, and spiritual health
* Parental Leave
Important Considerations
* Belonging to protected categories (Law No. 68/99) will be considered a preferential qualification.
* Work in a controlled manufacturing environment requiring gowning and protective clothing.
* Remove makeup, jewelry, contact lenses, nail polish, and/or artificial nails while in the manufacturing environment.
* Willingness to travel to internal/external Takeda meetings and events
* Flexibility to work in shifts
Locations
ITA - Rieti
Seniority level
Mid-Senior level
Employment type
Full-time
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