Global PAT Strategy & Innovation Lead

USA - 3345 Takeda Manufacturing U.S.A., Inc; Lexington (MA); Vor Ort; USD 177.000 - 278.000; Vollzeit

Zusammenfassung

Takeda is seeking a Process Technology & Innovation Lead PAT in Lexington, MA who will define and drive the global PAT strategy, including RTRT and APC, to strengthen process understanding, product quality, and operational performance across the manufacturing network.

You will lead global standards, governance, and portfolios, collaborating with MSAT, QA, Analytical Development, and Digital teams, ensuring GMP-compliant digital infrastructure, data integration, and lifecycle management of PAT

Qualifikationen

• Advanced degree preferred with substantial industry experience in PAT/Process Analytics
• Strong knowledge of GMP, GxP, and regulatory expectations
• Experience implementing PAT, RTRT, APC, soft sensors or real-time monitoring in validated manufacturing environments
• Demonstrated leadership of cross-functional technology innovation programs
• Fluency in English and ability to translate complex concepts into practical manufacturing solutions

Aufgaben

• Define and execute the global PAT technology and innovation strategy with a multi-year roadmap
• Establish harmonized PAT standards, governance frameworks and architectures across sites
• Lead a global PAT portfolio spanning analytics, modeling, digital twins, data platforms and AI-enabled insights
• Identify and industrialize emerging PAT technologies (NIR, Raman, UV, MS) through scale-up
• Drive RTRT and APC implementations in partnership with MSAT and other functions
• Collaborate to build scalable, GMP-compliant digital infrastructure and data integration capabilities
• Ensure validation, data integrity and lifecycle governance of PAT solutions
• Develop external partnerships to accelerate innovation and capability growth
• Monitor KPIs to show improvements in quality, yield, and reliability

Kenntnisse

PAT technology expertise

Process analytics

Leadership & stakeholder management

GMP / GMP compliance

English fluency

Ausbildung

Master's or PhD in Analytical Chemistry / Chemical/Process Engineering or related

Tools

GAMP 5

Data analytics platforms

Jobbeschreibung

Takeda is seeking a Process Technology & Innovation Lead PAT in Lexington, MA who will define and drive the global PAT strategy, including RTRT and APC, to strengthen process understanding, product quality, and operational performance across the manufacturing network.

You will lead global standards, governance, and portfolios, collaborating with MSAT, QA, Analytical Development, and Digital teams, ensuring GMP-compliant digital infrastructure, data integration, and lifecycle management of PAT