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Summary
John is an experienced Laboratory Consultant, licensed Genetics Lab Director / Technical Supervisor with 20+ years in diagnostic medical testing and research in various industries He has extensive experience laboratory lauchs, technical supervision, and expansion for new tests and technology in areas of Genomic Sequencing Procedures and Other Molecular Multianalyte Assays, Cytogenetics, and Molecular Pathology. He has expert knowledge of and experience with CDPH, CLIA / CAP/ISO15189/State regulations, laboratory operations and management, assay development and validation and is well versed novel molecular diagnostics technology, oncogene markers, that dictate laboratory testing platform development to penetrate in new customer markets. He has extensive laboratory operations experience including costing and budgeting, labor forecasting, hiring, staffing, workflow planning and business plan development for laboratory rollout plans. In addition, Marvin has served as the technical regulatory compliance roles for new launched laboratory ensuring successful licensure, inspections and audits.
Highlights
• 20+ years in diagnostic medical testing
• Private Corporation experience
• Expert in CDPH, CLIA / CAP / ISO15189/State
Regulations
• Clinical Laboratory expertise: Molecular diagnostics (oncology, prenatal genetics, infectious disease testing), immunology, clinical chemistry, flow cytometry, and mass spectrometry technologies.
• Business development and engagement to secure and acquire novel test clients and accounts
• Business / Lab Management & Planning Experience
• Licensed California Genetics Testing Scientist, ASCP Certified; qualified to direct high complexity medical diagnostic laboratories
• New Laboratory Services Rollout experience
• Molecular Diagnostics
• Assay Development Genomic Sequencing Procedures and Other Molecular Multianalyte Assays, Cytogenetics, and Molecular Pathology
Relevant Accomplishments
- Established new start-up clinical labs, from the ground up through CLIA, COLA, and CAP accreditation for multiple clients.
- Optimized, validated, and launched novel Laboratory Developed Tests for multiple clients.
- Developed quality assessment programs to ensure comprehensive monitoring of pre-, post-,and analytic processes to monitor testing performance and detect issues in a timely manner and develop effective corrective action plans when necessary.
- Responsible for overall operation and administration of a CLIA laboratory, ensuring that all duties were properly performed and applicable to CLIA regulations; Hired and maintained qualified personnel; Developed an effective quality system approach to laboratory testing that provided high accuracy and reliable patient test results.
- Developed and implemented the clinical, technical, fiscal, and quality programs of a diagnostic testing laboratory for corporation in a manner consistent with the needs of clinicians, customer hospitals and labs, and goals of the corporation. Oversaw validation and launch of new Laboratory Developed Tests and ensured that all activities were in full compliance with all regulatory requirements.
- Acted as subject matter expert for infectious disease testing, focusing on biological threat agents as part of the Federal Select Agent Program (FSAP).
- Planned and developed policies and procedures to ensure robust North Carolina statewide laboratory biosecurity and biosafety program that encompassed a continuous process of biological hazard recognition, accurate assessment, and comprehensive testing response.
Roles
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- Laboratory Manager / Site Director
- Principle Laboratory Consultant / Laboratory Manager
- Senior Laboratory Scientist III – Cytogenetics
Education/Certifications
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- California Licensed Genetics Scientist
- ASCP Genetics Technologist
- B.S. of Clinical Science
- ISO 9001 Lead Auditor
- Genetic Testing Certification
Request Expert / Similar Expert
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