MSAT Data Expert; Biologics

Overview

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 in CMC data for biologics, supporting governance and integration.

• 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.

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

Boston, MA, United States

Base salary: $ – $. Additional compensation may include short‑term and long‑term incentives. Employees are eligible for medical, dental, vision, 401(k) with company match, short‑term and long‑term disability, basic life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, up to 80 hours of sick time, and up to 120 hours of paid vacation.

Takeda is proud to commit to a diverse workforce and to provide equal employment opportunities to all employees and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, Vietnam‑era‑veteran status, special disabled‑veteran status, or any other characteristic protected by law, in accordance with applicable federal, state and local laws.

Full‑time, exempt