Senior CMC Data Architect II

Role Summary

The Senior CMC Data Architect II is an expert in treatment of “context” of scientific data. On top of proper management of data and meta data from both experiments and simulations, capturing data context is essential for efficient downstream data analysis and reuse of data beyond their original purpose. The role involves defining controlled and consistent terminology for manufacture and analytical data in the CMC space, utilizing taxonomies and ontologies for terminology maintenance, and driving data model and data governance use cases in collaboration with various teams and external groups.

Responsibilities

• Responsible for development and implementation of Dev Sci data standards and data governance best practices in collaboration with Dev Sci Use Case teams and scientists, AbbVie library and IR data engineering teams to ensure that Dev Sci scientific data is FAIR (findable, accessible, interoperable & reusable). Special focus: CMC process.
• Establishes clear decision criteria for the optimal depth to capture “context” in machine processible manner (controlled vocabulary, taxonomy, thesaurus, ontology) on reference use cases.
• Communicates data governance requirements to the Dev Sci community and drives alignment across scientific functions to ensure practices are well understood and followed.
• Initiates and functionally leads a future Data Steward community (embedded in Dev Sci functions) and partners with Information Research to create, review and approve new data system catalog terms in the CENTree ontology management system and other relevant systems. Owns Dev Sci data contracts.
• Interfaces with other data governance organizations and initiatives within Abbvie to coordinate “vocabulary” between research and operations: drives data architecture aspects in the OneCMC space.
• Actively participates in communities outside AbbVie and reviews relevant literature to learn best practices from vendors and industry peers.

Qualifications

• Bachelor’s Degree or equivalent education and typically 12+ years of industry experience, Master’s Degree or equivalent education and typically 10+ years of industry experience, PhD and typically 4+ years of industry experience.
• Relevant and credible/proven experience in the field of data context management.
• The ideal candidate brings a blend of strong scientific experience in the CMC space (ideally NCE & NBE) and proficient IT skills.
• Proven track record of evolving data architecture and solving data access challenges.
• Proven ability working in matrixed environment with diverse groups including subject matter experts, scientists and IT.
• Recognized and sought out as an expert in his/her discipline within the company and possibly externally.

Skills

• Data governance and data standards development
• Taxonomies, ontologies, controlled vocabularies
• CMC process knowledge and data context management
• Stakeholder collaboration across scientific, IT, and operations teams
• Communication of data governance requirements