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Job Description

About the role:

As the Manufacturing Sciences (MS) Digital and Data Science Lead, you will be responsible for leading digital transformation and digital maturity for the MS teams at MA Biologics Operations (MBO) and supporting the site digital transformation journey through collaboration with site Data, Digital & Technology (DD&T) and other functions.

How will you contribute:

• Develop and maintain MS digital transformation road map. Establish vision, roadmap, projects, and timeline to support MS digital transformation.

• Assume technical ownership on digital transformation projects, which include but is not limited to data analytics and predictive modeling, SIMCA real-time process monitoring, digital twins, dashboards using Spotfire, Qlik, or Power BI, Process Analytical Technology (PAT), and Knowledge Management.

•  Support technical/data system ownership of GxP and non-GxP systems such as Statistica and Spotfire.

• Be a data steward, ensuring data integrity, visibility, and usability.

• Support data engineering solutions to automate GxP activities.

• Support and coach other MS team members to enhance digital skills.

• Partner with other digital functions within MBO (DD&T) and global (Global Manufacturing

• Sciences (GMSci), Biologics Operating Unit (Bio OpU)) to define and drive digital projects to serve site business need. Build strong partnership across the organization.

• May support and execute Continued Process Verification (CPV) activities including routine.

• evaluation and escalation of signals and Annual Product Quality Reviews (APQRs).

• May support Manufacturing investigations as a digital and statistical expert.

• Develop and maintain MS digital transformation road map. Establish vision, roadmap, projects, and timeline to support MS digital transformation.

• Be the technical lead to execute approved digital transformation projects, (e.g. data analytics and predictive modeling, SIMCA real-time process monitoring, digital twins, dashboards using Spotfire, Quik, or Power BI, Process Analytical Technology (PAT), and Knowledge Management).

• Support routine Statistical Process Control (SPC) activities which may include Statistica workspace maintenance, routine process monitoring, biweekly SPC meetings, Annual Product Quality Reviews (APQRs).

• Collaborate with other SPC personnel to support site commercial and clinical program monitoring.

• Guide and coach other MS team members for increased digital maturity and digital capabilities. Representing MS in digital forums, Strategic Area Leadership Team (SALT), and digital Community of Practices (CoPs).

What you bring to Takeda:

• Bachelor’s degree in an engineering discipline, biological sciences or business (with a strong background in life sciences operations).

• Minimum of 8 years of combined experience in production environment utilizing GMP systems for supply chain (SAP or any other ERP) or manufacturing operations.

• management such as MES (Manufacturing Execution Systems).

• Sound understanding of manufacturing operations and related functions, from Supply Chain planning to product release.

• Experience with data analytic systems for data collection and reporting.

• Previous direct involvement in technology implementations for use in biologics,

• pharmaceuticals or devices, either in manufacturing operations or support function is highly desirable.

• Act as MS representative in cross functional teams where team presence is required.

• Consults and collaborates with cross-functional teams including but not limited to Manufacturing, Facilities and Engineering, Quality, Validation, Operational Excellence & Training, Supply Chain and DD&T.

• Interacts with vendors of applications, integrators and consultants during front end studies, design workshops and system implementation.

Desired:

• GxP software validation; Data governance and stewardship.

• Data mining, machine learning, statistical modeling.

• Some experience with Large Language Models (LLM) in Pharmaceutical applications.

• TIBCO Data Science / Statistica and TIBCO Spotfire.

• Qlik, Tableau, PowerBI, Power Automate, AWS, Big Data platforms.

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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:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$137,000.00 - $215,270.00

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

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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