Molecular Laboratory Director (NGS Focus)

Molecular Laboratory Director (NGS Focus)#26-00303 Milford, PA All On-site Job Description 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 -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 -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