CMC Business Analyst

Context:

The Business Analyst acts as the bridge between business and technology, translating CMC business needs and redesigned processes into actionable requirements and user stories that support the development of future digital solutions. The role supports the transition from design to implementation and contributes to the delivery of scalable, data-driven capabilities.

Day to day:

• Gather, analyze, prioritize, and document business and data requirements.

• Translate redesigned CMC processes into clear user stories and actionable requirements.

• Map CMC data flows, data sets, and business processes.

• Facilitate workshops, interviews, stakeholder discussions, and requirement validation sessions.

• Maintain and manage backlog items, reporting activities, process maps, and supporting documentation.

• Collaborate with business stakeholders, SMEs, architects, developers, and technology teams to ensure successful solution delivery.

• Support the implementation of data platforms and digital capabilities, including AI-assisted solutions, automated report generation, centralized data repositories, and agentic workflows.

• Ensure alignment between business requirements, enterprise standards, and data governance principles.

• Assess risks and support decision-making throughout the project lifecycle.

• Produce and maintain high-quality documentation such as process maps, data models, and communication materials.

• Contribute to the implementation of real-time and automated data flows, reducing manual data handling and improving data quality and usability.

Must have:

• Strong CMC (Chemistry, Manufacturing & Controls) background.

• Experience working directly within CMC environments, laboratories, CMC processes, or CMC submission dossier activities.

• Previous experience in pharmaceutical R&D, biotech, or life sciences environments.

• Proven business analysis experience, including requirements gathering, stakeholder management, and process analysis.

• Experience translating business needs into user stories, requirements, and digital solutions.

• Experience working with technology, data, architecture, or development teams.

• Strong stakeholder engagement skills, including interactions with senior stakeholders.

• Excellent English communication skills.

• Ability to work autonomously and proactively within agile squads.

• Experience with data mapping, data flows, and data management concepts.

Nice to have:

• Experience supporting digital transformation or business transformation programs.

• Exposure to data foundations and modern data platforms such as Snowflake or Databricks.

• Experience with AI-enabled, agentic, or automation-focused solutions.

• Knowledge of FAIR data principles.

• Experience with centralized data repositories, metadata management, or data governance initiatives.

• Experience accelerating or optimizing CMC processes.

• Exposure to laboratory digitalization, equipment connectivity, or laboratory experiment design.