MSAT Data Expert (Biologics)

About the role

Design, implement, and maintain CMC data standards, taxonomies, and ontologies for the biologics modality. Ensure high‑quality, analysis‑ready CMC data to support MSAT and manufacturing use cases.

Key responsibilities

• Develop and maintain CMC data taxonomies, ontologies, and metadata models for biologics.
• Implement CMC data models and business rules across systems and ensure data quality, consistency, and integrity.
• Support SOPs, standards, and job aids; act as CMC data steward for specific domains.
• Collaborate with MSAT teams to capture data correctly and enable integration across sites.
• Provide CMC data expertise to analytics and modelling initiatives and support GxP compliance.

Required profile

• Advanced degree in a STEM discipline.
• Minimum 5 years of pharma/biotech experience in CMC or MSAT for biologics.
• Experience working in a GxP environment.
• Strong collaboration and communication skills.

Required skills

• Data modeling and governance.
• Development of taxonomies, ontologies, and metadata models.
• Implementation of business rules across enterprise systems.
• Knowledge of CMC processes and GxP compliance requirements.