Lab Informatics Director

Description

Domain Experience (If any ) –Life Science or Bioinformatics or Pharmaceutical, Biotech, or CDMO environment

Project Management (e.g., PMP) or systems validation (e.g., GAMP) are a plus 

• Experience - in lab informatics
• Experience - leadership role within a pharmaceutical, biotech, or CDMO environment
• Experience-leading successful implementations of laboratory software systems in GxP-regulated environments.
• Experience -laboratory workflows, sample lifecycle management, and analytical instrumentation.
• Experience-system validation, data integrity principles, and GxP compliance.
• Experience-managing lab informatics systems across multiple global manufacturing or R&D sites.

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.

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

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.