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Director, Lab Informatics

Director, Lab Informatics

Sumeru SolutionsUnited States
12 hours ago
Job type
  • Full-time
  • Quick Apply
Job description

Position Summary :

The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory compliance. The incumbent will serve as the principal liaison between laboratory stakeholders, IT, QA, and regulatory affairs to deliver robust, scalable, and compliant digital solutions.

Key Responsibilities :

Strategic Leadership & Planning

  • Develop and lead the execution of a multi-year lab informatics roadmap aligned with corporate digital transformation goals.
  • Conduct market and internal needs assessments to identify technology gaps and opportunities for automation and integration.
  • Provide vision and strategic direction for the adoption of cloud-based and AI-driven technologies.
  • Influence senior leadership decisions by providing insight into informatics trends and capabilities.

Project Oversight & System Ownership

  • Lead end-to-end lifecycle management of key lab systems including ELN (Electronic Lab Notebook), LIMS (Laboratory Information Management System), CDS (Chromatography Data System), and SDMS (Scientific Data Management System).
  • Drive cross-functional project teams through software selection, system design, implementation, validation, and deployment.
  • Maintain ownership of system governance, change management, and version control processes.
  • Ensure timely resolution of system issues and continuous improvement through user feedback and performance metrics.

    • Operations & Compliance

  • Ensure informatics systems are compliant with global regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
  • Collaborate with QA and Compliance teams to perform risk assessments and periodic reviews of computerized systems.
  • Lead preparation and support during regulatory inspections and internal audits.
  • Establish robust procedures for electronic data management, archival, and retrieval.

    • Team Leadership

  • Recruit, develop, and manage a multidisciplinary team of informatics professionals, system administrators, and project managers.
  • Foster a culture of collaboration, accountability, and innovation.
  • Provide coaching, mentoring, and performance management to support professional growth and knowledge sharing.

    • Cross-functional Collaboration

  • Act as the primary interface between scientific end-users, IT infrastructure teams, software vendors, and senior management.
  • Translate complex scientific and operational requirements into technical specifications and implementation plans.
  • Drive user adoption and change management initiatives through effective communication and training programs.

    • Design and facilitate the transition plan of technology responsibilities

    build the accelerated adoption strategy for LIMS 12.2

    Provide leadership support of the LIMS 21.3 upgrade

    Provide hands on execution / leadership for the deployment of the LIMS / SAP interface

    Accelerate legacy LIMS decomm strategy

    Support ELN roadmap for 2026 and 2027

    Help drive final decision with Empower / Chromeleon

    Support solution decision and strategic plan for EM rollout (global)

    Qualifications :

  • Bachelor's degree in Life Sciences, Computer Science, Bioinformatics, or a related field is required; advanced degree (MS, PhD, or MBA) preferred.
  • Minimum of 10 years of progressive experience in lab informatics, with at least 5 years in a leadership role within a pharmaceutical, biotech, or CDMO environment.
  • Proven track record in leading successful implementations of laboratory software systems in GxP-regulated environments.

    • Skills & Knowledge

  • Deep understanding of laboratory workflows, sample lifecycle management, and analytical instrumentation.
  • Expertise in system validation, data integrity principles, and GxP compliance.
  • Strong project management skills with experience using Agile and Waterfall methodologies.
  • Excellent interpersonal, organizational, and communication skills, with the ability to influence at all levels of the organization.

    • Preferred Qualifications :

  • Experience managing lab informatics systems across multiple global manufacturing or R&D sites.
  • Familiarity with integration of lab systems with enterprise platforms such as ERP (SAP), MES, and QMS.
  • Understanding of emerging technologies including AI / ML, NLP, and data visualization tools.
  • Certifications in project management (e.g., PMP) or systems validation (e.g., GAMP) are a plus.
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    Lab Director • United States

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