Job Title: Director, LIMS Engineering Location: Remote Job Type: Full-Time Job Summary: We are seeking a seasoned
Director of LIMS Engineering to lead the strategy, development, and optimization of our Laboratory Information Management System (LIMS), with a primary focus on SAPIO LIMS. This role will manage a team of internal developers and external contractors, ensuring the LIMS infrastructure is scalable, compliant, and aligned with business and regulatory needs. The ideal candidate will bring a strong background in clinical diagnostics, hands-on technical skills, and proven leadership experience.
Key Responsibilities: - Strategic Leadership: Define and execute the LIMS roadmap aligned with clinical, technical, and operational goals.
- LIMS Design & Management: Lead design, development, configuration, and integration of SAPIO LIMS for laboratory workflows.
- Hands-on Development: Contribute to code development (minimum 30%) with a focus on Python for webhook and integration development.
- Team Leadership: Manage and mentor LIMS engineers and collaborate with external contractors to deliver high-quality solutions.
- Workflow Optimization: Partner with lab, IT, and bioinformatics teams to streamline workflows and improve data integrity.
- Compliance: Ensure adherence to CLIA, CAP, HIPAA, and FDA regulations through proper system validation and data security practices.
- Project Oversight: Act as the technical lead on LIMS initiatives, ensuring delivery within budget and timeline using structured SDLC processes.
- Systems Integration: Work closely with IT to integrate LIMS with ERP, EHR, bioinformatics pipelines, and analytics tools.
- Vendor Management: Serve as the primary point of contact with SAPIO LIMS vendors to manage relationships and resolve issues.
- Support & Training: Provide technical support and conduct training sessions to maximize user adoption and system efficiency.
Qualifications: - Bachelor's or Master's degree in Computer Science, Bioinformatics, Engineering, or related field.
- 5+ years of experience in LIMS development and management within clinical diagnostics, biotech, or pharma.
- Hands-on experience with SAPIO LIMS or similar systems, including configuration, customization, and automation.
- Familiarity with NGS workflows and clinical lab operations.
- Proven leadership experience managing internal teams and contractors.
- Strong understanding of regulatory standards: CLIA, CAP, HIPAA, FDA 21 CFR Part 11.
- Proficiency in Python and database platforms (SQL, Oracle, PostgreSQL).
- Excellent project management, communication, and problem-solving skills.
