Kelaca is looking for a LIMS Implementation Project Manager for our client partner in Durham, NC. The LIMS Project Manager will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information Management System (LIMS). This onsite role requires close collaboration with both internal teams and the external project team, ensuring that all project workstreams are aligned, and the system is tailored to meet our operational needs. You will be responsible for ensuring the successful delivery of the LIMS project, from planning to post-implementation support, with a strong focus on regulatory compliance and lab efficiency.

Key Responsibilities:

• Project Leadership: Lead the onsite planning, execution, and monitoring of the LIMS implementation, ensuring all deliverables are met on time and within budget.
• Workstream Coordination: Manage all internal teams (lab operations, IT, quality assurance) and external resources to ensure efficient project collaboration.
• Project Planning: Develop and maintain detailed project plans, timelines, and budgets using Smartsheet to ensure smooth project execution.
• Risk & Issue Management: Identify and resolve project risks, issues, and dependencies to keep the project on track and avoid disruptions.
• Customization & Integration: Oversee the customization of LIMS to meet requirements and ensure seamless integration with laboratory instruments and existing systems.
• User Acceptance Testing: Coordinate and oversee user acceptance testing (UAT) to validate system functionality and ensure alignment with our needs.
• Training & Support: Develop and implement training programs for staff to ensure effective system adoption and usage.
• Regulatory Compliance: Ensure that the LIMS implementation complies with all relevant regulatory standards, including GLP, GMP, and 21 CFR Part 11, with a focus on data integrity and validation.
• Post-Implementation Optimization: Provide ongoing support and lead continuous improvement initiatives to ensure the LIMS remain aligned with our evolving needs.
• Reporting: Prepare and present project status reports to senior management using Smartsheet and other reporting tools.

Minimum Qualifications – Education:

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

Minimum Qualifications – Experience:

• Minimum of 5 years of experience managing LIMS implementations in laboratory, pharmaceutical, or bioanalytical environments.
• Proven experience implementing comprehensive LIMS systems for companies in similar industries.
• Strong understanding of laboratory workflows and regulatory compliance in pharmaceutical or biotech settings.

Minimum Qualifications – Skills:

• Proficiency in Smartsheet for project management.
• Extensive knowledge of LabVantage LIMS or similar LIMS platforms, including customization and integration.
• Strong communication and leadership skills to manage both internal teams and external vendors.

Preferred Qualifications:

• Certifications: PMP certification or equivalent project management qualification.
• Technical Skills: Familiarity with laboratory automation systems and scientific data management.
• Soft Skills: Strong analytical and problem-solving skills, with experience managing complex projects in a regulated environment.

Working Environment:

• Location: This is a fully onsite role at our Durham, NC location, requiring close collaboration with laboratory, IT, and project teams to ensure successful implementation and optimization of the LIMS platform.
• Travel: Occasional travel may be required to other locations for project implementation and support.

Job Type: Full-time

Hours of Work in Office: Monday-Friday; 8 am-5 pm

FLSA Exemption Status: Exempt

Apply to Kelaca today so we can schedule a conversation with you to further discuss this exciting opportunity.

Kelaca is an Equal Opportunity Employer and does not discriminate in employment based on: age, disability, national origin, race, color, religion, protected veteran status, genetic information, gender, sex, gender identity, sexual orientation, pregnancy, or other non-merit factor.