Molecular Laboratory Director (NGS Focus)

Molecular Laboratory Director (NGS Focus)

Location: Milford, PA (Onsite with some flexibility; must reside within commuting distance)

Position Overview

We are seeking an experienced and highly qualified Molecular Laboratory Director to lead and oversee our molecular diagnostics laboratory operations. This role requires deep expertise in Next-Generation Sequencing (NGS) and compliance with regulatory standards, including New York State requirements. The ideal candidate will combine strong technical knowledge with leadership capabilities to ensure high-quality, accurate, and timely testing services.

Key Responsibilities

• Provide overall leadership and direction for the molecular laboratory, ensuring operational excellence and regulatory compliance
• Oversee and validate NGS-based genetic testing workflows, including assay development, validation, and implementation
• Ensure compliance with CLIA, CAP, NYS DOH, and other applicable regulatory and accreditation standards
• Serve as the Laboratory Director of record for molecular pathology testing, including test sign-out where applicable
• Develop, review, and approve standard operating procedures (SOPs), quality control, and quality assurance programs
• Monitor laboratory performance metrics and implement continuous improvement initiatives
• Provide scientific and technical guidance to laboratory staff, including training and competency assessments
• Collaborate with cross-functional teams (clinical, R&D, operations) to expand and enhance testing capabilities
• Stay current with advancements in molecular diagnostics, genomics, and regulatory requirements
• Ensure proper documentation and readiness for audits and inspections

Qualifications & Requirements

• PhD, MD, or equivalent in Molecular Biology, Genetics, Pathology, or a related field
• Board certification in Molecular Pathology (e.g., ABMGG, ABP, or equivalent)
• Active New York State (NYS) laboratory license in Molecular Pathology (required)
• Demonstrated experience with Next-Generation Sequencing (NGS) technologies and clinical genetic testing
• Prior experience serving in or qualifying for a Laboratory Director role under CLIA/CAP regulations
• Strong knowledge of regulatory standards (CLIA, CAP, NYS DOH)
• Proven leadership experience managing laboratory teams and operations
• Excellent analytical, organizational, and communication skills