Process Technology & Innovation Lead PAT

Takeda•Hikari, MA

3d•$177,000 - $278,080•Hybrid

About The Position

Accountable for defining and governing the future-state Process Analytical Technology (PAT), Real-Time Release Testing (RTRT) and Advanced Process Control (APC) architecture across Takeda's global manufacturing network, including technology standards, investment prioritization, innovation deployment and value realization. Own the long-term manufacturing capability roadmap for PAT-enabled manufacturing, ensuring readiness for next-generation process platforms, advanced control strategies, autonomous operations and digital manufacturing evolution. Own the PAT process technology and innovation portfolio across Takeda's manufacturing network, translating strategic priorities into a practical multi-year roadmap that advances real-time process understanding, process control, product quality assurance and manufacturing competitiveness, while positioning Takeda at the forefront of PAT, advanced analytics and smart manufacturing. Serve as the MSAT point of accountability for PAT process technology strategy, innovation governance, prioritization and deployment, ensuring strong alignment with the overall GSQ innovation strategy, Global MSAT objectives and enterprise priorities, and establish a harmonized PAT framework that enables consistent adoption of analytical technologies, real-time monitoring and control strategies across manufacturing platforms and sites. Build, manage and continuously optimize an integrated PAT innovation portfolio spanning advanced analytical technologies, in-line and on-line monitoring solutions, process modeling, automation, digital twins, data platforms and AI-enabled process intelligence, with clear prioritization, resource requirements, risk management and value realization plans to deliver both near-term operational improvements and sustainable long-term impact. In close liaison with Pharmaceutical Sciences, Analytical Development and Manufacturing functions, drive the end-to-end industrialization of PAT solutions, from technology scouting, evaluation and proof of concept through pilot implementation and full-scale deployment, and ensure successful integration into GMP operations through appropriate validation, data integrity, regulatory compliance and lifecycle management, realizing Real-Time Release Testing (RTRT) and advanced process control opportunities where applicable. Develop PAT capabilities across the organization, foster a culture of data-driven decision making and scientific innovation, and build strategic partnerships with GSQ, Pharmaceutical Sciences, academia, suppliers, technology providers and industry consortia, while monitoring emerging trends in process analytics, sensing technologies, chemometrics, AI, digital manufacturing and regulatory science to continually expand, de-risk and accelerate Takeda's PAT innovation pipeline and manufacturing transformation agenda.

Requirements

Advanced degree (Master's or PhD) in a relevant scientific or engineering field, for example analytical chemistry, chemometrics, chemical or process engineering, pharmaceutical sciences, data science, computer science or a related discipline, or equivalent experience.
Fluent in English.
Around ten or more years, in PAT, process analytics, process control, automation, or manufacturing technology within pharma or another regulated industry, including leadership of cross-functional or program-scale work.
Hands-on experience across several of the following: Instrumentation & Control, PAT instrumentation and sensing (NIR, Raman, UV, mass spectrometry), process automation, chemometrics and multivariate analysis, process modeling and soft sensors, advanced process control, RTRT, and the data and analytics platforms behind them, with a track record of taking them into validated use.
Demonstrated delivery of PAT or digital manufacturing programs with measurable results (for example quality and yield improvements, cycle-time or release-time reduction, right-first-time, or cost).
Familiarity with computerized system validation, GAMP 5, data integrity, QbD and continuous improvement approaches (for example DMAIC, Kaizen and GEMBA).
Strong business sense and the ability to build an investment case, prioritize a technology portfolio and show the value came through.
Comfortable working across cultures, geographies and complex, matrixed stakeholder groups, and leading technical people.

Responsibilities

Own the PAT technology, innovation and digital enablement strategy for the GSQ manufacturing network, translating Global MSAT and GSQ priorities into a multi-year PAT roadmap that advances real-time process understanding, process control, product quality assurance and manufacturing competitiveness.
Act as the MSAT point of accountability for PAT strategy, governance, prioritization and deployment, and establish a harmonized PAT framework that enables consistent adoption of analytical technologies, real-time monitoring and control strategies across platforms and sites.
Build, manage and continuously optimize an integrated PAT innovation portfolio spanning advanced analytical technologies, in-line and on-line monitoring, process modeling, automation, digital twins, data platforms and AI-enabled process intelligence, with clear prioritization, resourcing, risk management and value realization.
Apply a structured portfolio management approach (for example the Gartner TIME framework: Tolerate, Invest, Migrate, Eliminate) to rationalize analytical and digital technologies, directing investment to the highest-value PAT capabilities and consolidating or retiring duplicated or ageing tools.
Accountable for delivering measurable business value through PAT deployment, including improvements in manufacturing robustness, product quality, yield, productivity, release cycle time, process capability, operational efficiency and supply reliability.
Lead technology scouting, evaluation and proof of concept for emerging PAT and process-analytics technologies, including spectroscopy and sensing (for example NIR, Raman, UV and mass spectrometry), soft sensors, chemometrics and multivariate data analysis, and translate the promising ones into actionable roadmaps and investment cases.
Drive the end-to-end industrialization of PAT solutions, from proof of concept through pilot to full-scale deployment, in close liaison with Pharmaceutical Sciences, Analytical Development, Manufacturing and Quality, ensuring clean integration into GMP operations.
Partner with MSAT-APMC (Advanced Process Modeling and Control) to connect PAT signals to advanced process control, model predictive control and real-time release, and to bring mechanistic and data-driven models into validated use.
Work with DD&T (Data, Digital and Technology) and Engineering to design, develop, test and deploy the data platforms, automation and infrastructure that PAT and process intelligence depend on, making sure the choices are fit for GMP, cyber secure and scalable.
Realize Real-Time Release Testing (RTRT) and advanced process control opportunities where applicable, building the control strategy, validation and regulatory case together with Quality and Regulatory.
Establish PAT and analytical data foundations, including instrument integration, contextualized process and quality data, and the analytics environment that chemometric models and AI-enabled process intelligence rely on, with data integrity designed in.
Define PAT standards, methods, reference architectures and blueprints, and drive their consistent adoption across sites to cut duplication and enable scale.
Build validation, data integrity, model governance, computerized system validation (GAMP 5) and regulatory compliance into every PAT solution from the outset, and manage lifecycle and change control across the installed base.
Manage technology and vendor partnerships across analytical instrument and PAT providers, modeling and analytics vendors, automation partners, academia, suppliers and industry consortia, including obsolescence management and a technology refresh roadmap.
Define, track and communicate PAT performance and value metrics, including adoption, model performance, data quality, quality and yield improvements, and cycle-time and release-time reduction, and report transparently to PT&I and Global MSAT leadership.
Develop PAT capability across the organization through hiring, upskilling, knowledge sharing and a culture of data-driven decision making and disciplined experimentation, and engage senior stakeholders across MSAT, Pharmaceutical Sciences, Manufacturing, Quality, Engineering, DD&T and Site Leadership.
Keep the team's PAT and digital accountabilities aligned with the overall remit of the Head of Process Technology and Innovation and the wider GSQ innovation strategy, complementing rather than duplicating the mandates of DD&T, APMC, Analytical Development and Engineering.