Business Analyst

You will bridge the gap between scientific operations and technical implementation within a regulated laboratory environment.

Responsibilities

• Capture detailed business requirements by working with scientists, lab managers, QA, and IT stakeholders.
• Translate scientific and operational needs into functional and technical specifications for LabVantage LIMS and ELN modules.
• Map analytical processes including sample preparation, assay execution, method validation, and data lifecycle management.
• Document reagent lifecycle processes, including creation, qualification, expiry tracking, and usage logging.
• Design dashboards, reporting structures, and data models to support operational insights and regulatory needs.
• Ensure all documentation meets GxP, 21 CFR Part 11, and ALCOA+ data integrity principles.

Required Skills

• 5+ years of experience as a Business Analyst in bioanalytical or pharmaceutical laboratories.
• Hands-on understanding of bioanalytical workflows, sample handling, assay execution, and calibration/controls.
• Direct experience with method validation, sample analysis, stability studies, and data review.
• Proven experience working in or supporting regulated labs, CROs, or pharma R&D.
• Strong experience working with LIMS or ELN systems.
• Knowledge of SQL and data analytics tools.
• Bachelor's degree.

Preferred Skills

• Experience with LabVantage modules including LV Analytics, LV ELN, Stability, Sample Management, or Instrument Management.
• Experience with reagent and inventory management solutions.
• Experience in Computer System Validation (CSV) activities.