DPO Chromatography Data Systems

Role: Digital Product Owner for Chromatography Data Systems (CDS) within J&J's R&D Digital team, responsible for leading the strategy, design, and implementation of chromatography data solutions across development labs. Objectives include ensuring regulatory compliance, data integrity, and seamless integration of CDS with laboratory systems, supporting digital transformation efforts. Responsibilities encompass defining future state architecture, managing SOPs and audits, aligning stakeholders, overseeing vendor relationships, and driving continuous improvement of systems like Empower, OpenLab CDS, and Chromeleon. The role emphasizes supporting clinical development with robust data management aligned to FAIR principles and regulatory standards. Requirements: Bachelor's in Chemical Engineering, Chemistry, Pharma or related; minimum 5 years' industry experience in pharma/biotech; practical knowledge of lab systems supporting process development and clinical manufacturing; familiarity with GMP, GAMP, SDLC, and digital transformation projects. Preferred skills include experience with GxP compliance, project management, agile methodologies, and global stakeholder engagement. High-Value: focus on laboratory data systems, regulatory compliance, GxP, GMP, digitalization, and cross-functional collaboration within pharmaceutical R&D environments. Work setup involves limited travel, based in Malvern or Spring House, PA, with a global scope.