Process Technology & Innovation Lead PAT

Takeda Pharmaceutical Company Limited; Lexington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Takeda Pharmaceutical Company Limited is seeking a senior MSAT leader to define and govern PAT, RTRT and APC architecture across Takeda's global manufacturing network in support of digital manufacturing and advanced process control.

You will own long‑term roadmaps, drive cross‑functional collaboration with QA, Manufacturing, Analytics and DD&T, and ensure data integrity, regulatory compliance and scalable solutions across platforms and sites.

Qualifications

• Significant experience with Process Analytical Technology (PAT), Real‑Time Release Testing (RTRT) and Advanced Process Control (APC).
• Experience leading MSAT initiatives across manufacturing networks and ensuring GMP compliance.

Responsibilities

• Own the PAT technology, innovation and digital enablement strategy for the GSQ manufacturing network.
• Act as the MSAT accountability point for PAT strategy, governance, prioritization and deployment across platforms and sites.
• Build and optimize an integrated PAT portfolio including analytics, monitoring, modeling, automation, digital twins and AI-enabled intelligence.
• Lead end-to-end industrialization of PAT solutions from proof of concept through pilot to full-scale deployment with GMP integration.
• Partner with cross-functional teams to connect PAT signals to advanced process control and real-time release opportunities.
• Define, track and communicate PAT performance and value metrics, including adoption and operational impact.

Job description

Job Description

About the role:

• 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.

How you will contribute:

• 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,