Business Analyst

Role: Business Analyst Work location: Spring House, PA

Job Description: We have a requirement to onboard a Business Analyst with a strong background in BioAnalytical laboratory processes. Below are the details of the requirement.

We are seeking an experienced Business Analyst with a strong background in BioAnalytical laboratory processes and hands-on involvement in LIMS/ELN implementations, ideally LabVantage LIMS. The selected candidate will play a critical role in gathering requirements, defining workflows, and supporting the design and implementation of LIMS, ELN, Reagent Management, and Analytics capabilities for our pharmaceutical client.

Key Responsibilities: Key Responsibilities

• Business Analysis & Requirements Gathering
• Work closely with scientists, lab managers, QA, and IT stakeholders to capture detailed business requirements for BioAnalytical workflows.
• Analyze current state processes and define future-state workflows aligned with LabVantage capabilities.
• Translate scientific and operational needs into functional and technical specifications.
• LIMS / ELN Design & Implementation
• Support configuration, customization, and deployment of LabVantage LIMS and ELN modules.
• Define test cases, support UAT, and ensure system validation aligns with GxP requirements.
• Help map BioAnalytical processes such as sample preparation, assay execution, method validation, result review, and data lifecycle management.
• Reagent & Inventory Management
• Document reagent lifecycle processes including creation, qualification, expiry tracking, and usage logging.
• Work with lab teams to implement traceable and compliant reagent management workflows.
• Analytics & Reporting
• Collaborate with data analytics teams to design dashboards and reporting structures.
• Define data models and KPIs to support operational insights and regulatory needs.
• Compliance & Documentation
• Ensure all requirements and design documentation meet pharma regulatory guidelines (GxP, 21 CFR Part 11, data integrity ALCOA principles).
• Support audit readiness for the system once implemented.

What are the Mandatory skills and skill proficiencies required for this position? Required Skills & Experience Must-Have

• 5 years of experience as a Business Analyst in BioAnalytical or pharmaceutical laboratories.
• Hands-on understanding of BioAnalytical workflows, including: o Sample handling, assay execution, calibration/controls o Method validation, sample analysis, stability studies o Data review and regulatory documentation
• Experience working in or supporting BioAnalytical Labs (CROs, pharma R&D, regulated labs).
• Strong experience with LIMS/ELN systems-preferably LabVantage LIMS.

What are the Optional skills and skill proficiencies for this position? Nice-to-Have

• Experience with Reagent/Inventory Management solutions.
• Exposure to LabVantage modules such as: o LV Analytics o LV ELN o Stability, Sample Management, Instrument Management
• Knowledge of SQL or data analytics tools.
• Experience in system validation (CSV) activities.