MSAT Data Expert (Biologics)

Takeda; Zürich; Vor Ort; CHF 94.787 - 148.938; Vollzeit

Zusammenfassung

Takeda in Boston, MA is seeking a CMC Data Specialist to design, implement, and maintain CMC data standards for biologics, ensuring analysis-ready data for MSAT and manufacturing.

You will translate global CMC data strategy into SOPs, act as SME, and collaborate across MSAT to enable data integration and governance, while supporting GxP inspections.

Qualifikationen

• 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.

Aufgaben

• Design, implement, and maintain CMC data standards, taxonomies, and ontologies for biologics.
• Ensure high-quality, contextualized, and analysis-ready CMC data for MSAT and manufacturing use cases.
• Translate global CMC data strategy into SOPs and business rules.
• Act as SME in CMC data for biologics, supporting governance and integration.
• Develop and maintain CMC data taxonomies, ontologies, and metadata models.
• Implement CMC data models and business rules across systems.
• Ensure data quality, consistency, and integrity.
• 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.

Kenntnisse

Advanced degree in STEM

5 years pharma/biotech CMC/MSAT biolog

Data modeling or governance

GxP environment experience

Strong collaboration skills

Ausbildung

Advanced degree in STEM

Jobbeschreibung

Job Description

• 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.

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.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Yes

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.