Process Technology & Innovation Lead PAT

3345 Takeda Manufacturing U. • Lexington, MA

2d • Onsite

About The Position

The Process Technology & Innovation Lead PAT is responsible for defining and driving Takeda’s global Process Analytical Technology (PAT) strategy, including Real-Time Release Testing (RTRT) and Advanced Process Control (APC). This role leads the development and deployment of innovative analytical and digital manufacturing technologies to strengthen process understanding, product quality and operational performance. Working across Global MSAT, Manufacturing, Quality and Digital functions, the role ensures scalable, compliant and value-driven implementation of PAT solutions across Takeda’s manufacturing network.

Requirements

• Advanced degree (Master’s or PhD) in Analytical Chemistry, Chemical or Process Engineering, Pharmaceutical Sciences, Chemometrics, Data Science, Computer Science or a related discipline, or equivalent professional experience.
• Approximately 10 or more years of experience in Process Analytical Technology, process analytics, process control, automation or manufacturing technology within the pharmaceutical industry or another highly regulated environment.
• Strong technical expertise in PAT instrumentation and sensing technologies, including NIR, Raman, UV, mass spectrometry, chemometrics, multivariate data analysis and process modeling.
• Demonstrated experience implementing PAT, advanced process control, soft sensors, automation or Real-Time Release Testing solutions within validated manufacturing environments.
• Proven track record of leading cross-functional technology innovation or digital manufacturing programs, delivering measurable improvements in quality, yield, operational efficiency and manufacturing performance.
• Solid understanding of GMP requirements, computerized system validation, GAMP 5, data integrity, Quality by Design (QbD) and continuous improvement methodologies such as DMAIC, Kaizen and GEMBA.
• Strong strategic and business acumen, with the ability to manage technology portfolios, develop investment cases, prioritize resources and demonstrate business value.
• Excellent leadership, stakeholder management and communication skills, with experience influencing senior stakeholders and collaborating across complex, global and matrixed organizations.
• Fluency in English, combined with strong analytical thinking, an innovative mindset and the ability to translate complex scientific and technological concepts into practical manufacturing solutions.

Responsibilities

• Define and execute the global PAT technology and innovation strategy, establishing a multi-year roadmap aligned with Global MSAT, GSQ and enterprise priorities.
• Establish harmonized PAT standards, governance frameworks and technology architectures to enable consistent adoption of analytical technologies, real-time monitoring and advanced control strategies across manufacturing sites.
• Lead and optimize a global PAT innovation portfolio covering advanced analytical technologies, process modeling, automation, digital twins, data platforms and AI-enabled process intelligence, ensuring effective investment prioritization and measurable value creation.
• Identify, evaluate and industrialize emerging PAT technologies, including spectroscopy (NIR, Raman, UV and mass spectrometry), sensing technologies, chemometrics and multivariate data analysis, from proof of concept through full-scale deployment.
• Drive the implementation of Real-Time Release Testing (RTRT) and Advanced Process Control (APC) solutions in partnership with MSAT, Pharmaceutical Sciences, Analytical Development, Manufacturing, Quality and Regulatory teams.
• Collaborate with DD&T and Engineering to establish scalable, secure and GMP-compliant digital infrastructure, data integration capabilities and analytical platforms supporting PAT deployment and advanced process intelligence.
• Ensure robust validation, data integrity, model governance, regulatory compliance and lifecycle management of PAT solutions, incorporating GAMP 5 principles and appropriate change control processes.
• Develop strategic partnerships with technology providers, analytical instrument suppliers, academia and industry consortia to accelerate innovation, strengthen technical capabilities and support technology lifecycle management.
• Define and monitor performance indicators to demonstrate improvements in product quality, manufacturing robustness, yield, productivity, release cycle times and supply reliability, while developing organizational PAT capabilities and fostering a culture of scientific innovation.

Benefits

• Compensation is an important factor as you consider the next step in your career.
• We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
• For information about our benefits, please click here.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior