Business Analyst (Bioanalytical / LIMS / ELN)

Business Analyst (Bioanalytical / LIMS / ELN)

Spring House, PA (On-site)

Full-time

Job Summary

We are seeking an experienced Business Analyst with a strong background in Bioanalytical laboratory processes to support a pharmaceutical client. This role involves gathering requirements, defining workflows, and supporting the implementation of LIMS, ELN, Reagent Management, and Analytics solutions, with a preference for experience in LabVantage LIMS.

Key Responsibilities

Business Analysis & Requirements Gathering

Collaborate with scientists, lab managers, QA, and IT teams to gather and document business requirements

Analyze current processes and define future-state workflows aligned with system capabilities

Translate scientific and operational needs into functional and technical specifications

LIMS / ELN Implementation

Support configuration, customization, and deployment of LIMS/ELN systems (preferably LabVantage)

Define test cases, support User Acceptance Testing (UAT), and ensure system validation compliance

Map bioanalytical workflows including sample preparation, assay execution, method validation, and data lifecycle

Reagent & Inventory Management

Document and implement reagent lifecycle processes (creation, qualification, expiry tracking, usage)

Ensure traceability and compliance in reagent management workflows

Analytics & Reporting

Partner with data teams to design dashboards and reporting solutions

Define KPIs and data models to support business insights and regulatory needs

Compliance & Documentation

Ensure all documentation aligns with regulatory standards (GxP, 21 CFR Part 11, ALCOA+)

Support audit readiness and system validation activities

Required Qualifications

Bachelor’s degree in Life Sciences, Computer Science, or related field

5+ years of experience as a Business Analyst in Bioanalytical or pharmaceutical lab environments

Strong understanding of bioanalytical workflows, including:

Sample handling and assay execution

Method validation and sample analysis

Data review and regulatory documentation

Hands-on experience with LIMS/ELN systems (LabVantage preferred)

Experience working in regulated lab environments (pharma, CROs, or R&D labs)

Preferred Skills

Experience with reagent or inventory management systems

Familiarity with LabVantage modules (Analytics, ELN, Stability, Sample Management, Instrument Management)

Knowledge of SQL or data analytics tools

Experience with Computer System Validation (CSV)

Additional Information

On-site role – candidates must be able to work in Spring House, PA

Mandatory in-person meet and greet as part of the interview process

Why Join Us?

Work with leading pharmaceutical clients on cutting-edge lab systems

Opportunity to contribute to impactful bioanalytical and regulatory projects

Collaborative and cross-functional work environment

Pay: $50.00 - $60.00 per hour

Work Location: In person