Biologics CMC Data Architect & Governance SME

USA - 3345 Takeda Manufacturing U.S.A., Inc; Cambridge (MA); In loco; USD 116.000 - 182.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CMC data

Data governance

GxP experience

Collaboration

MSAT exposure

Formazione

Advanced degree in STEM

Descrizione del lavoro

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.