Piper Companies is seeking a LIMS Project Manager to lead the implementation, integration, and ongoing support of a Laboratory Information Management System (LIMS) for a growing gene therapy company in the Raleigh, NC area. This is a high-impact role that will coordinate cross-functional teams and ensure system capabilities align with stakeholder needs across Quality Control, Microbiology, Quality Assurance, Validation, and IT.
Responsibilities for the LIMS Project Manager include:
- Manage the full lifecycle of LIMS implementation, including planning, vendor coordination, configuration oversight, validation, and go-live
- Act as the primary liaison between internal teams and external vendors/consultants
- Define project scope, goals, and deliverables aligned with business and regulatory requirements
- Develop and manage detailed project plans, budgets, timelines, and risk mitigation strategies
- Lead requirements gathering and translate business needs into functional LIMS specifications
- Oversee system configuration, testing (IQ/OQ/PQ), data migration, and user training
- Ensure compliance with 21 CFR Part 11, GAMP 5, and GxP guidelines
- Maintain project documentation including SOPs, validation protocols, and training materials
- Support post-implementation optimization and continuous improvement initiatives
- Collaborate closely with IT, QA, Lab Operations, and Regulatory teams
Requirements for the LIMS Project Manager include:
- Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field (advanced degree preferred)
- 5+ years of experience managing LIMS or enterprise laboratory software projects
- Strong understanding of laboratory workflows in QC, analytical, or R&D environments
- 5+ years of experience in cGMP environments with a focus on CSV/CSA and direct LIMS support
- Hands-on experience with one or more LIMS platforms (e.g., LabWare, LabVantage)
- Equivalent combinations of education and experience will be considered
Compensation for the LIMS Project Manager includes:
- Salary Range: Competitive and based on experience
- Benefits: Full suite including medical, dental, vision, 401(k), PTO, holidays, and sick leave as required by law
Keywords: LIMS, LabWare, LabVantage, CSV, CSA, GxP, 21 CFR Part 11, GAMP 5, QC, QA, validation, laboratory systems, project management, data migration, SOPs, life sciences, biotech, pharmaceuticals
Application Start Date: July 21, 2025
Application Window: Open for a minimum of 30 days from posting
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