Digital Specialist – Analytical Development

Introduction & Summary

The Digital Specialist in Analytical Development plays a vital role within the Analytical Development Sciences (ADS) department, contributing to analytical method development and stability studies in compliance with FDA requirements. The successful candidate will engage with diverse teams, translating business processes into structured data requirements, while ensuring regulatory compliance.

Main Responsibilities

• Interact with analytical development scientists, quality, IT, and digital teams.
• Analyze existing lab processes and data flows.
• Perform end-to-end process and data mapping.
• Translate business and scientific processes into structured data requirements.
• Challenge IT solutions from a business perspective.
• Ensure compliance by design (GxP / ALCOA+).
• Support deployment of digital solutions and assist end users.
• Participate in discussions to align stakeholders and find pragmatic compromises.

Key Requirements

• Strong experience in data mapping, data flow design, or business/data analysis.
• Ability to translate laboratory processes into structured data requirements.
• Understanding of GxP environments and ALCOA+ principles.
• Experience working at the interface between business and IT.
• Fluent English.
• Strong stakeholder management and communication skills.

Nice to Have

• Experience in CMC, Analytical Development, or QC laboratories.
• Familiarity with systems such as ELN (IDBS), LIMS (LabWare), Power BI.
• Exposure to digital transformation programs in regulated environments.
• Knowledge of data governance or data engineering concepts.

Other Details

This position operates within a hybrid working model (2 days on site) and is suitable for full-time applicants, with potential for 4 days per week. The role is part of a significant digital transformation initiative and involves collaboration across various departments until the end of 2026, with a strong possibility of extension into 2027.