Process Technology & Innovation Lead PAT

USA - 3345 Takeda Manufacturing U.S.A., Inc; Lexington (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

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

Qualifications

• 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

Responsibilities

• 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

Skills

PAT technology expertise

Process analytics

Leadership & stakeholder management

GMP / GMP compliance

English fluency

Education

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

Tools

GAMP 5

Data analytics platforms

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. Locations Lexington, MACambridge, 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 Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and we are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.

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.