The incumbent will lead the research, development, validation, and transfer of clinical laboratory tests into high-throughput routine operations for the diagnosis, treatment, and prevention of human disease. This role combines scientific innovation with operational excellence to ensure the reliability, accuracy, and regulatory compliance of molecular and genomic testing.
Scientific & Technical Leadership
1. Serve as a subject matter expert (SME) for clinical assays and laboratory procedures.
2. Design, develop, and validate pre-analytical, analytical, and post-analytical processes.
3. Lead troubleshooting and resolution of analytical or instrumentation issues.
4. Perform and interpret high-throughput genomic and molecular assays, including next-generation sequencing (NGS).
Operational Excellence
5. Implement end-to-end automation to meet high-throughput demands.
6. Ensure instrument qualification and method validation are completed within strict timelines.
7. Drive continuous process improvement to enhance efficiency, accuracy, and turnaround times.
8. Develop and maintain operational procedures, validation studies, and related documentation.
Quality & Compliance
9. Adhere to all quality control procedures to maintain specimen integrity and result accuracy.
10. Support ISO 15189 accreditation and compliance with relevant regulatory standards (UKAS, CAP, HTA, etc.).
11. Monitor and report quality metrics, performance indicators, and quality events promptly.
12. Participate in internal audits and regulatory due diligence reviews.
Training & Collaboration
13. Assist with staff training, competency assessment, and knowledge transfer.
14. Collaborate with cross-functional teams, vendors, and research partners to support laboratory innovation.
15. Lead or contribute to laboratory projects as assigned by leadership.
Qualifications
16. Master’s degree in a relevant field (Ph.D. preferred).
17. Minimum 5+ years of clinical laboratory experience, including molecular and NGS-based assays.
18. Proven expertise in assay and process development, project management, and vendor collaboration.
19. HCPC registration preferred.
20. Strong analytical, organizational, and communication skills.
21. Working knowledge of regulatory and accreditation requirements (ISO 15189, CAP, UKAS, HTA).
22. Proficiency in Microsoft Office and laboratory information systems (LIS/LIMS).
Knowledge, Skills & Abilities
23. Scientific Literacy: Ability to evaluate scientific literature and author validation reports or publications.
24. Quantitative Skills: Strong understanding of statistics, probability, and data interpretation.
25. Problem Solving: Ability to analyze complex data and resolve issues in dynamic environments.
26. Collaboration: Effective communicator across multidisciplinary teams.
Working Conditions
27. Clinical laboratory environment with exposure to biological and chemical hazards.
28. PPE required: lab coat, gloves, and closed-toe shoes.
29. Full-time on-site presence required; weekend or holiday work may be needed.
30. Some travel may be required.
Physical Requirements
31. Ability to stand, sit, and move within the lab; manual dexterity to operate instruments.
32. Capable of lifting up to 25 lbs.
33. Ability to reach, bend, and handle routine laboratory activities safely.
Reports To
34. Laboratory Director (no direct reports).