MSAT Data Expert (Biologics)
Takeda•Boston, MA
•$116,000 - $182,270•Onsite
About The Position
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.
Requirements
- 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.
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.
- Contribute to knowledge sharing and continuous improvement.
Benefits
- 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
- well-being benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
