MSAT Data Expert (Biologics)

Takeda; Boston (MA); On-site; USD 116,000 - 182,000; Full time

Job summary

Takeda in Boston, MA seeks a CMC data expert to design, implement, and maintain CMC data standards, taxonomies, and ontologies for biologics. You will translate global data strategy into SOPs and govern data across MSAT and manufacturing use cases.

You will collaborate with MSAT teams, enable cross-system integration, ensure data quality and governance, support GxP readiness, and act as SME for CMC data domains.

Qualifications

• Advanced degree in STEM.
• 5 years in pharma/biotech with CMC or MSAT experience in biologics.
• Experience in data modeling or governance.
• GxP environment experience.
• Strong collaboration skills.

Responsibilities

• Develop and maintain CMC data taxonomies, ontologies, and metadata models for biologics.
• Implement CMC data models and business rules across systems.
• Ensure data quality, consistency, and integrity.
• Support SOPs, standards, and job aids.
• Collaborate with MSAT teams for proper data capture and usage.
• Enable CMC data integration across systems and sites.
• Provide CMC data expertise to analytics and modelling initiatives.
• Act as CMC data steward for specific domains.
• Support GxP compliance and inspections.
• Contribute to knowledge sharing and continuous improvement.

Skills

CMC data

Biologics

Data governance

Collaboration

MSAT experience

Education

STEM degree

Job description

Job Description

About the role:

• Design, implement, and maintain CMC data standards, taxonomies, and ontologies for the biologics modality.
• Ensure high-quality, contextualized, and analysis-ready CMC process data to enable MSAT and manufacturing use cases.
• Translate global CMC data strategy into practical implementation, including SOPs and business rules.
• Act as a subject matter expert (SME) in CMC data for biologics, supporting governance and integration.

How you will contribute:

• Develop and maintain CMC data taxonomies, ontologies, and metadata models for biologics.
• Implement CMC data models and business rules across systems.
• Ensure data quality, consistency, and integrity.
• Support SOPs, standards, and job aids.
• Collaborate with MSAT teams for proper data capture and usage.
• Enable CMC data integration across systems and sites.
• Provide CMC data expertise to analytics and modelling initiatives.
• Act as CMC data steward for specific domains.
• Support GxP compliance and inspections.
• Contribute to knowledge sharing and continuous improvement.

What you bring to Takeda:

• Advanced degree in STEM.
• 5 years in pharma/biotech with CMC or MSAT experience in biologics.
• Experience in data modeling or governance.
• GxP environment experience.
• Strong collaboration skills.

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:

Boston, MA

U.S. Base Salary Range:

$116,000.00 - $182,270.00

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.

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

Boston, MACHE - Glattpark (Opfikon) - Zurich HQ

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.