MSAT Data Expert (Biologics)

USA - 3345 Takeda Manufacturing U.S.A., Inc; Cambridge (MA); Presencial; USD 116.000 - 182.000; Jornada completa

Descripción de la vacante

Takeda in Boston, MA is seeking a highly skilled CMC data expert to design and govern data standards for biologics, translating global CMC strategy into practical implementation across SOPs and business rules. You will act as SME and support governance and MSAT data needs.

The role emphasizes data modeling, governance, GxP compliance, and cross-functional collaboration to enable analytics, integrations, and continuous improvement.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CMC data

Data governance

GxP experience

Collaboration

MSAT exposure

Educación

Advanced degree in STEM

Descripción del empleo

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.

For information about our benefits, please.

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.

Takeda is an equal opportunity employer.

For applicants of U.S and Puerto Rico positions: to learn about our commitment to Equal Employment Opportunity (EEO).

If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please.

Locations

Boston, MACHE - Glattpark (Opfikon) - Zurich HQ

Worker Type

Employee

Worker Sub-Type

Regular Time Type Full time Job Exempt Yes

Legal Disclaimer

It 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.

Company Overview

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 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.