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About the role (Responsibilities):
- Design, implement, and maintain CMC data standards, taxonomies, and ontologies for biologics.
- Ensure high-quality, contextualized, analysis-ready CMC process data to enable MSAT and manufacturing use cases.
- Translate global CMC data strategy into implementation (SOPs and business rules).
- Serve as a subject matter expert (SME) in biologics CMC data; support governance and integration.
- Develop/maintain taxonomies, ontologies, and metadata models; implement data models and business rules across systems.
- Ensure data quality, consistency, and integrity; support SOPs/standards/job aids.
- Collaborate with MSAT teams; enable CMC data integration across systems/sites.
- Provide expertise to analytics/modelling; act as a CMC data steward for domains.
- Support GxP compliance and inspections; contribute to knowledge sharing/continuous improvement.
What you bring (Qualifications/Skills):
- 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.
Compensation/Benefits (as stated):
- Base salary range: $116,000β$182,270.
- May be eligible for incentives and benefits including medical/dental/vision, 401(k) with match, disability/life insurance, tuition reimbursement, paid time off, holidays, well-being benefits, sick time, and vacation.