Sr. Spclst , Data Engineering

Job Description

Position Description:

Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. 

dCMC intends to deliver:

• Increased productivity and speed to clinic/market

• Accelerated timelines for site, filing, and launch readiness

• Improved access to product and process data

• Streamlined transfer of process and product knowledge with reduced error rates

A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMC’s vision of frictionless flow of data from development to commercialization and supply.

A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation.     

Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst, will support development and implementation of the regulatory authoring application by identifying, implementing and enforcing data standards from key source systems; contributing to data model development; and assisting in evolving data products for automated filing content. The Sr. Specialist will work closely with cross-functional teams to ensure integration of the data into regulatory documentation, supporting consistent data standards and the growth or our regulatory data ecosystem.

The responsibilities of the dCMC Data Analyst include:

• Data Standardization and Source Integration: Define and implement data standardization rules and practices across multiple source systems . Support the extraction, transformation, and validation of process and analytical data to ensure consistency and quality before auto generation into regulatory documentation. Collaborate with source system SME’s and data stewards to understand data nuances and improve data quality at the source.

• Data Model Development and Maintenance: Contribute to the creation and refinement of the data models that represent regulatory filing sections and their underlying data relationships. Assist in documenting data models, metadata, and data lineage to support transparency and traceability.  Support iterative updates to data models as new sources are connected or regulatory requirements evolve.

• Data Product Support and Evolution: Develop and maintain data products that enable auto-generation of regulatory filing content. Collaborate with product owners and technical teams to gather requirements, test new features, and trouble shoot data related issues. Support user onboarding and training related to data standards and product usage, including defining data governance requirements and expectations. 

• Cross-Functional Collaboration and Communication Work closely with regulatory authoring, IT, data strategy, and source system teams to align on data requirements and understanding integration priorities. Participate in meetings to gather feedback, report progress, and escalate issues as needed. Assist in preparing documentation, reports, and presentations related to data standardization and product status.

Required Skills and Experience

• Understanding of data within the CMC (Chemistry, Manufacturing, and Controls) domain, including experience in analytical testing, manufacturing processes, and laboratory development.

• Basic understanding of regulatory authoring processes and the role of data in regulatory filings, including how data supports submissions and the importance of accuracy and traceability.

• Familiarity with source systems such as LIMS, Veeva, and document formats like PDF, enabling effective data extraction, validation, and integration.

• Experience in data standardization, modeling, and semantic ontologies to define standards, maintain data models, and enhance data interoperability.

• Strong analytical skills with attention to detail and accuracy in data handling.

• Understanding of master data management and manufacturing ontologies to support consistent data definitions, relationships, and governance.

• Proven success collaborating within cross-functional teams and communicating effectively with technical and business stakeholders to align on data requirements and project goals.

Preferred Experience and Skills

• Preferred direct experience in the development and commercialization of processes and analy