LIMS Project Manager

The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information Management System (LIMS). This onsite role requires close collaboration with both BioAgilytix's internal teams and the external project team, ensuring that all project workstreams are aligned, and the system is tailored to meet BioAgilytix’s 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.

• 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 BioAgilytix 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 BioAgilytix’s 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 BioAgilytix’s needs.
• Training & Support: Develop and implement training programs for BioAgilytix 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 remains aligned with BioAgilytix’s evolving needs.
• Reporting: Prepare and present project status reports to senior management using Smartsheet and other reporting tools.

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

• 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.

• 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.

• 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.

• Location: This is a fully onsite role at BioAgilytix’s 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 BioAgilytix locations for project implementation and support.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of any employment Visa at this time.

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.