Laboratory Director NxGen MDx - 2.3 Grand Rapids, MI Job Details Full-time 1 day ago Qualifications Regulatory inspections CAP guidelines Regulatory compliance Pathology Molecular diagnostic equipment Medical genetics and genomics Assay development Quality control audit Proficiency testing CMS regulatory compliance Managing laboratory teams Bachelor's degree Laboratory regulatory affairs Centers for Medicare and Medicaid Services (CMS) Medical laboratory work Molecular diagnostics supervision CLIA regulations Pathology testing Biomedical regulatory compliance Verification of laboratory test methods Quality audits Test validation method Molecular biology Audit support Quality assurance experience within healthcare Molecular analysis

Full Job Description Required Qualifications Education:

MD, DO, PhD, DCLS or equivalent doctoral degree in molecular biology, genetics, clinical laboratory science, pathology, microbiology, chemistry or a closely related field from an accredited institution.

CLIA Eligibility:

Candidate must meet all requirements to serve as a High‑Complexity Laboratory Director under CLIA regulations.

Board Certification:

Strong preference for board certification through one of the following: American Board of Medical Genetics and Genomics (ABMGG); American Board of Pathology (Molecular Genetic Pathology); American Board of Bioanalysis (HCLD - Molecular Diagnostics); American Board of Clinical Chemistry (DABCC - Molecular Diagnostics); or another HHS‑approved laboratory director certification. Experience At least five years of experience in molecular diagnostics, including a minimum of two years directing or supervising high‑complexity testing. Hands‑on expertise with PCR/qPCR/RT‑PCR, next‑generation sequencing, molecular oncology, infectious disease testing and pharmacogenomics. Demonstrated capability in assay validation, verification studies, CAP/CLIA inspections, quality management, laboratory‑developed tests and proficiency testing.

Preferred Qualifications:

Prior leadership experience directing a molecular reference laboratory processing high test volumes. Experience supporting payer audits, Medicare compliance and commercial assay development. Publications, presentations or recognized expertise in molecular diagnostics. Familiarity with CAP accreditation, New York State CLEP requirements, FDA and LDT regulatory frameworks, MolDx and LCD coverage policies and laboratory billing compliance.

Key Responsibilities:

Provide overall scientific, technical and regulatory oversight of all laboratory operations. Ensure compliance with CLIA, CAP, state and other regulatory/accreditation requirements. Review and approve new assay validations, verification studies, SOPs, quality indicators and proficiency‑testing performance. Oversee quality assurance and quality control programs and support audit responses. Provide consultation to ordering providers and supervise technical and quality personnel. Serve as the designated CLIA Laboratory Director for

NxGen MD Job Type:

Full-time Work Location:

In person