The Digital Chemistry, Manufacturing, and Controls (dCMC) initiative aims to solve the business and technical problem of enabling a digital continuum of data from development through manufacturing for products and processes, leading to increased productivity, accelerated timelines, improved data access, and streamlined knowledge transfer 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.
- 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, conflict resolution, and ownership-driving skills.
- Excellent verbal and written communication, with ability to tailor messages and actively listen.
- Highly organized, able to prioritize tasks to ensure project success.
- Hybrid work model consisting of three total days on-site per week, Monday - Thursday, with Friday designated as a remote-working day.
