Director of Laboratory Operations

Director of Laboratory Operations, Anatomic Pathology

Summary

• The Director of Laboratory Operations, Anatomic Pathology will oversee clinical trial testing for phases I, II, and III using Immunohistochemistry (IHC), in situ hybridization (ISH), and multiplex immunofluorescence (mIF) methodologies. The Director will oversee a team of scientists and technologists who develop and validate assays to Sponsors' specifications, and will deliver test results for clinical trial studies on time and with high quality. The Director of Laboratory Operations, Anatomic Pathology will oversee delivery for multiple, concurrent studies, and will work across functions (Project Management, Data Management, Quality Assurance, Environmental Health and Safety) to comply with contractual and regulatory requirements.

Key Responsibilities:

• Oversee laboratory operations, ensuring adherence to CAP/CLIA regulations, and GCLP standards
• Develop and implement strategies for improving workflow, quality control, and patient safety
• Collaborate with clinical, administrative, and operational leaders to align laboratory services with organizational goals
• Evaluate and optimize Laboratory Information Management Systems (LIMS) or Laboratory Information System (LIS)
• Direct complex technical projects, including assay development and validation for IHC, ISH, and/or mIF testing, process standardization, and quality improvement initiatives
• Evaluate assay platforms and software to facilitate testing, imaging, and reporting
• Work with Quality Assurance to perform assay, platform, and software validations
• Work with Quality Assurance to investigate deviations and non-conformances
• Perform duties as delegated by the Medical Director of the laboratory

Qualifications:

• Education: Master's degree in clinical science, laboratory science, chemistry, biology, or related field, PhD Preferred

Experience:

• 7+ years of progressive leadership in laboratory operations
• 7+ years of experience in tissue-based laboratory testing
• 3+ years in clinical trial testing environmentExperience with automated stainers (e.g. Leica Bond systems)
• Experience with imaging systems (e.g. Vectra Polaris, Aperio)
• Experience with image analysis software (e.g. HALO, PathAI, Visiopharm)
• Preferred
• Experience with mIF assay development and validation
• Experience with Design Control as per 21CFR820

Skills:

• Strong financial acumen, including budget management and workforce planning
• Knowledge of Lean, Six Sigma, or other process improvement methodologies preferred
• Experience with Laboratory Information Management Systems (LIMS) is a plus