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, and streamlined transfer of process and product knowledge with reduced error rates.
Requirements
- Knowledge of manufacturing, testing, quality, and supply chain processes from late clinical development through commercialization, with practical insight into how these operations generate CMC regulatory content
- Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation
- Hands-on experience in regulatory authoring and submission documentation, including preparing, reviewing or supporting filing ready content and structured filing outputs.
- Proven ability to map business processes, perform gap analyses, and redesign workflows to improve efficiency, reduce errors, and enable digitization.
- Experience in digitization and data management initiatives in regulated environments, including source-document identification/prioritization, metadata design, and content/data modeling.
- Working knowledge of key enterprise systems (LIMS, MES, SAP) and practical experience coordinating their integration into data pipelines, APIs or ETL processes for downstream authoring use
- Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document assembly) from source systems.
Responsibilities
- map end-to-end processes that produce regulatory authoring data, convert complex tasks into clear workflows, identify gaps, and prioritize solutions to improve efficiency and compliance.
- identify true source documents for past regulatory filings to prioritize digitization and integration.
- drive decisions in collaboration with the data strategy team on areas of priority and opportunities for further investment.
- organize and lead information gathering sessions with the internal CMC community, collaborate with cross-functional teams to gather business requirements, and coordinate with IT, Research, and Manufacturing to capture feedback on developed capabilities to ensure effective digital solution integration and adoption.
- create detailed process documentation, including workflows and data models.
- support project management by tracking tasks, reporting status, coordinating meetings, managing timelines and risks, and monitoring KPIs to measure digitization success.
- support application deployment and use, with responsibilities ranging from data template creation and maintenance, onboarding data stewards from the business, authoring SOPs for new application releases, and troubleshooting use and data management.
Other
- Strong team contributor, promoting an inclusive and collaborative environment
- Effective problem-solving, demonstrated escalation, and strong accountability for deliverables.
- Excellent verbal and written communication, with the ability to tailor messages for the audience and actively listen.
- Highly organized, able to prioritize tasks to ensure project success.
- Demonstrated project management skills, such as facilitating cross-functional workshops, gathering requirements, KPI tracking, and on-boarding of new users.
