MSAT Data Expert (Biologics)
Core
Design, implement, and maintain CMC data standards, taxonomies, and ontologies for biologics to ensure high-quality, analysis-ready data for MSAT and manufacturing use cases.
Role type
Senior CMC Data Expert (Biologics)
Builds
CMC data taxonomies, ontologies, metadata models, and business rules for biologics manufacturing and MSAT systems.
Domain
Biopharmaceuticals / Biologics / CMC Data Governance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
CMC data modeling, data governance, biologics domain expertise, GxP compliance, SOP development, data integration, metadata management, business rule implementation, data quality assurance, knowledge sharing
Preferred skills
Advanced degree in STEM, experience in data modeling or governance, experience in GxP environment
Technologies
CMC data standards, taxonomies, ontologies, metadata models, MSAT systems
Responsibilities
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
Seniority
Senior, hands-on IC