When you work as the Lead ELN/LIMS Administrator at KCAS, you get to further our mission by serving as the primary owner and strategic lead for KCAS Bio’s Electronic Laboratory Notebook (ELN) and Laboratory Information Management System (LIMS) platforms.
While ensuring these systems effectively support regulated bioanalytical operations, data integrity, compliance, and scalability across KCAS Bio laboratories, you will partner with scientific, quality, IT, and business leadership to drive system configuration, continuous improvement, user adoption, and alignment with business and regulatory requirements.
In this roll, we will rely on you to:
- Serves as the functional and technical lead for ELN and LIMS platforms across KCAS Bio, acting as the primary subject matter expert and system owner.
- Leads the implementation, configuration, validation, enhancement, and ongoing maintenance of ELN/LIMS systems in a GxP-regulated CRO environment.
- Ensures ELN/LIMS systems meet data integrity, security, audit trail, and regulatory compliance requirements (e.g., FDA, GLP, GCP, 21 CFR Part 11).
- Partners closely with laboratory leadership, QA, IT, and scientific teams to translate laboratory workflows and business needs into system designs and configurations.
- Drives continuous improvement initiatives by identifying opportunities to streamline workflows, improve data quality, and enhance system usability.
- Oversees system validation activities, including validation planning, execution, documentation, and change control.
- Establishes and maintains system governance, including user access controls, role definitions, configuration standards, and documentation practices.
- Provides leadership for ELN/LIMS-related projects, including system upgrades, vendor coordination, and cross-functional implementations.
- Develops and delivers training for ELN/LIMS users to ensure effective adoption and consistent use across the organization.
- Acts as a key point of contact during internal audits, client audits, and regulatory inspections related to ELN/LIMS systems.
- Monitors system performance, data quality metrics, and user feedback to proactively address issues and risks.
- Collaborates with vendors and external partners to manage support, enhancements, and roadmap planning.
- Supports integration of ELN/LIMS with other enterprise systems as needed (e.g., instruments, data analysis platforms, or ERP systems).
- Supports the company brand in all interactions, serving as a positive brand ambassador for KCAS Bio.
To qualify specifically for this role, you will have:
- Bachelor’s degree in a scientific, technical, or related discipline required.
- Advanced degree or relevant certifications (e.g., informatics, quality, or project management) preferred.5+ years of experience leading, administering, or supporting ELN and/or LIMS systems in a regulated laboratory environment.
- Experience working within a pharmaceutical company, CRO, biotech organization, or similarly regulated scientific environment.
- Demonstrated experience with system validation, change control, and regulatory compliance expectations.
- Strong understanding of laboratory workflows, bioanalytical operations, and data lifecycle management.
- Experience managing cross-functional projects and working with both technical and scientific stakeholders.
What We Do
With its presence in three locations across North America and Europe, KCAS Bio is a leading contract research organization (CRO) employing top scientific talent and providing comprehensive bioanalytical services to the global biopharmaceutical industry from early discovery support through product registration and beyond. The collaboration of the three entities allows for global support in bioanalytical, biomarker, immunogenicity, cellular and molecular assay services along with clinical kitting and sample management. The KCAS family of companies operates in state-of-the-art facilities in the United States and Europe. This business structure enables the expertise, capacity, and flexibility to support the development of all types of drugs, biologics, cell and gene therapies to improve health worldwide. Our purpose is to help accelerate the discovery and development of life-changing drugs smoothly, safely and sustainably.
