Job Description

Company/Project Description

Kelaca is seeking a LIMS Implementation Project Manager for our client partner in Durham, NC. This role focuses on the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information Management System (LIMS). The position is onsite and requires collaboration with internal teams and external project resources to ensure the system is tailored to operational needs. The role emphasizes regulatory compliance and improving laboratory efficiency throughout the project lifecycle, from planning to post-implementation support.

Role Description (Responsibilities)

The LIMS Implementation Project Manager will:

• Project Leadership: Lead the onsite planning, execution, and monitoring of the LIMS implementation, ensuring deliverables are on time and within budget.

• Workstream Coordination: Manage internal teams (lab operations, IT, quality assurance) and external resources for effective collaboration.

• Project Planning: Create and maintain detailed project plans, timelines, and budgets using Smartsheet.

• Risk & Issue Management: Identify, manage, and resolve risks, issues, and dependencies to maintain project continuity.

• Customization & Integration: Oversee LIMS customization and ensure seamless integration with laboratory instruments and existing systems.

• User Acceptance Testing: Coordinate and oversee User Acceptance Testing (UAT) to validate system functionality.

• Training & Support: Develop and implement staff training programs for system adoption.

• Regulatory Compliance: Ensure compliance with GLP, GMP, and 21 CFR Part 11, focusing on data integrity and validation.

• Post-Implementation Optimization: Provide ongoing support and lead continuous improvement initiatives to align the LIMS with evolving operational needs.

• Reporting: Prepare and present project status reports to senior management using Smartsheet and other reporting tools.

Required Hard Skills

• Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field.

• Minimum 5 years of experience managing LIMS implementations in laboratory, pharmaceutical, or bioanalytical environments.

• Extensive knowledge of LabVantage LIMS or similar platforms, including customization and integration.

• Strong understanding of laboratory workflows and regulatory compliance in pharmaceutical or biotech settings.

• Proficiency in Smartsheet for project management.

Required Soft Skills

• Strong communication and leadership skills to manage diverse internal and external stakeholders.

• Effective problem-solving and analytical skills to manage complex project challenges.

Nice-to-Have Skills

• Certifications: PMP or equivalent project management certification.

• Technical Skills: Familiarity with laboratory automation systems and scientific data management.

• Experience in regulated environments with complex projects.

Benefits

As part of the role, the following comprehensive benefits package is offered:

• Medical :

  • Care Coordination

  • Health Savings Account (HSA)

  • Dental and Vision Coverage

  • Flexible Spending Account (FSA)

• Insurance :

  • FREE Life and Disability Insurance

  • FREE Employee Assistance Program (EAP)

• Financial & Legal :

  • 401(k) Plan

  • Legal Protection Benefits

• Additional Perks :

  • Pet Benefits

  • Employee Discount Program

• Work-Life Balance :

  • Parental Leave

  • Paid Time Off (PTO)

  • Company Holidays

Job Tags

Similar Jobs