Process Technology & Innovation Lead PAT

Takeda Pharmaceutical Co.; Lexington (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a senior Process Technology & Innovation Lead PAT in Lexington, MA. You will define the global PAT strategy, drive RTRT and APC initiatives, and lead a cross-functional team across MSAT, Manufacturing, Quality and Digital to deploy scalable PAT solutions.

You will advance analytics, data platforms, digital twins and AI-enabled process intelligence, ensuring regulatory compliance and GAMP 5-aligned practices across sites in a highly regulated environment.

Qualifications

• Advanced degree in a relevant scientific or engineering discipline or equivalent experience.
• 10+ years in PAT, process analytics, automation or manufacturing tech in pharma or regulated settings.
• Strong expertise in PAT instrumentation, sensing, multivariate analysis and process modeling.

Responsibilities

• Define and execute the global PAT strategy and multi-year roadmap.
• Establish standardized PAT governance, architectures and real-time monitoring.
• Lead portfolio including automated analytics, digital twins, data platforms and AI.
• Industrialize emerging PAT tech from proof-of-concept to full-scale deployment.
• Implement RTRT and APC in partnership with MSAT, QA, Manufacturing and Regulatory.
• Collaborate on digital infrastructure, data integration and compliant platforms.
• Ensure validation, data integrity, lifecycle management and regulatory compliance.
• Develop external partnerships to accelerate innovation and lifecycle support.
• Define KPIs to improve quality, yield, efficiency and supply reliability.

Skills

PAT strategy

RTRT

APC

Spectroscopy

Data platforms

Regulatory compliance

Cross-functional leadership

GAMP 5

Education

Advanced degree in Analytical Chemistry / Chemical Engineering

Job description

Job Description

About the role: 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.

How you will contribute:

• 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.

What you bring to Takeda:

• 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.

Takeda Compensation and Benefits Summary

We understand 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 Location: Lexington, MA

U.S. Base Salary Range: $177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA, Cambridge, MA, CHE - Glattpark (Opfikon) - Zurich HQ, Dublin-Baggot Street, Ireland, Hikari, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.