Laboratory Information Management System Subject Matter Expert

Title: LIMS SME

Overview

We are seeking an experienced LIMS Subject Matter Expert (SME) to support a global assessment initiative for a major life sciences client. This role will focus on evaluating current laboratory systems, identifying operational gaps, and recommending the optimal Laboratory Information Management System (LIMS) solution to standardize lab operations across the organization. The ideal candidate will bring deep functional expertise in multiple LIMS platforms, a strong understanding of pharmaceutical manufacturing processes, and a proven track record in consulting engagements.

Key Responsibilities

• Lead the functional assessment of existing LIMS platforms across global lab operations.
• Evaluate multiple LIMS solutions such as LabWare, LabVantage, and STARLIMS, providing objective recommendations based on client needs.
• Collaborate with client stakeholders and the consulting partner Gartner to assess current systems and define the future-state LIMS strategy.
• Identify and document system gaps in compliance, data integrity, and workflow efficiency.
• Support the development of a roadmap for LIMS standardization across 17 initial labs, with scalability to over 350 global labs.
• Provide expert insight into regulatory compliance and best practices for lab systems in pharmaceutical manufacturing.
• Prepare and present findings and recommendations to executive and technical leadership teams.

Qualifications

• Minimum of 8–10 years of functional experience with multiple LIMS platforms (LabWare, LabVantage, STARLIMS, etc.).
• Strong understanding of pharmaceutical manufacturing processes and related regulatory requirements (FDA, GxP).
• Demonstrated experience in consulting or advisory roles, preferably with global clients.
• Excellent communication and stakeholder management skills.
• Ability to translate complex technical requirements into clear business recommendations.
• Willingness to travel domestically as required (TBD).

Project Context

• The client operates 350+ laboratories globally.
• A recent FDA CAPA observation has prompted an initiative to strengthen and standardize lab systems.
• The client currently uses Lablinks in 17 labs (4 actively in use).
• The target is to implement a standardized LIMS solution by Q2 next year.