Associate Fellow - SAS Laboratory Informatics

The Laboratory Informatics Lead is responsible for the lifecycle management, optimization, and compliance of computerized laboratory systems that support analytical testing within Special Analytical Services (SAS) and broader R&I scientific operations. The role exists to ensure scientific software, laboratory data systems, and analytical instrument platforms remain reliable, compliant, and fit for their intended use while advancing digital laboratory capabilities across R&I through laboratory informatics, automation, Electronic Laboratory Notebooks (ELN), Laboratory Information Management Systems (LIMS), AI-enabled solutions, and other emerging technologies. By serving as the bridge between laboratory operations, quality, validation, enterprise technology, and software vendors, this position enables efficient digital laboratory workflows, maintains data integrity, supports computerized system validation, and allows scientists to focus on other activities rather than technology-related challenges.

25% - Serve as the laboratory informatics subject matter expert by developing laboratory technology standards, providing technical guidance on computerized laboratory systems, supporting strategic planning, and preparing technical documentation, reports, and presentations for management and cross-functional stakeholders.

25% - Lead the lifecycle management of computerized systems supporting all R&I as well as Special Analytical Services (SAS), including laboratory informatics platforms, analytical instrument software, scientific data systems, and digital laboratory technologies to ensure reliable, compliant, and efficient laboratory operations.

20% - Partner with scientists and cross-functional R&I organizations to lead laboratory digital transformation initiatives through implementation of Electronic Laboratory Notebooks (ELN), Laboratory Information Management Systems (LIMS), workflow automation, AI-enabled technologies, system integration, and electronic data management. Evaluate, develop, and implement digital solutions that improve laboratory efficiency, data quality, collaboration, and end-to-end scientific workflows across R&I.

15% - Lead computerized system validation (CSV), change management, data integrity, disaster recovery, and software qualification activities to maintain laboratory systems in a validated state and support compliance with FDA, cGMP, ISO/IEC 17025, and other applicable regulatory requirements.

15% - Lead laboratory technology projects, including implementation of new laboratory software, analytical instrument integrations, software upgrades, infrastructure changes impacting laboratory systems, and evaluation of emerging laboratory informatics technologies. Coordinate activities with enterprise technology, quality, validation, instrument vendors, and software suppliers for all R&I.

• Master's in computer applications

15 years' experience

• Works primarily in laboratory environment across R&I, supporting computerized laboratory systems and scientific data workflows. Including in a regulated analytical laboratory environment.
• Demonstrated ability to identify, evaluate, and implement AI-enabled solutions and emerging digital technologies to automate laboratory workflows, improve operational efficiency, reduce costs, enhance data quality, and transform scientific processes through innovative ways of working.
• Requires a strong understanding of laboratory operations, analytical instrumentation, computerized analytical systems, and scientific software applications.
• Demonstrated knowledge of data integrity principles, computerized system lifecycle management, and computer system validation (CSV) within FDA/cGMP and/or ISO/IEC 17025 regulated environments.
• Ability to analyze complex laboratory workflows and translate scientific requirements into effective digital and automated solutions.
• Ability to coordinate and lead multiple software implementations, system upgrades, instrument integrations, and change control activities with internal stakeholders and external vendors.
• Strong troubleshooting and problem-solving skills for laboratory software, instrument interfaces, data acquisition systems, and electronic laboratory records.
• Excellent written and verbal communication skills with the ability to collaborate effectively with scientists, quality, regulatory, validation (CSA), and enterprise technology teams.
• Ability to manage multiple priorities while supporting business-critical operations across R&I.
• Familiarity with laboratory informatics platforms such as chromatography data systems (CDS), laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), scientific data management systems (SDMS), and analytical instrument software is highly desirable.
• Lead work within laboratory environments supporting installation, qualification, validation, or troubleshooting of computerized analytical systems.
• Serves as the laboratory informatics subject matter expert responsible for ensuring computerized systems effectively support scientific operations, workflows, data integrity, regulatory compliance, and business continuity within R&I. Partners with scientists, quality, validation, enterprise technology, and software vendors to optimize laboratory processes and ensure computerized systems remain fit for their intended use throughout their lifecycle.