SAMIR ALERYANI
Ph.D., FAACC, NRCC, MT, CLS
Collegeville
Summary
As an accomplished medical laboratory scientist and educator with over 20 years of experience in academic leadership, clinical chemistry, and program development, I seek to contribute to the College of Medical Applied Sciences as a Fulbright Scholar by fostering excellence in laboratory science education and advancing quality assurance practices. My goal is to collaborate with faculty to strengthen curriculum development, mentor future professionals, and support the establishment of internationally aligned laboratory training programs that address regional healthcare challenges and elevate diagnostic standards.
Overview
20
20
years of professional experience
1
1
Certification
Work History
CLIA Clinical Laboratory Director
CREATVBIO
05.2024 - Current
- Company Overview: Cancer Diagnostic Lab
- Direct the CLIA lab and prepared it for CAP certification and New York certification.
- Cancer Diagnostic Lab
Clinical Laboratory Director
SERES THERAPEUTICS
01.2021 - 12.2023
- Directed and oversaw construction of the lab (CapEx and OpEx of over 3.5 million budget).
- Laboratory Director of new CLIA/CAP donor screening laboratory.
- Responsible for establishing and overseeing the lab, developing custom screening assays, and managing our relationships with our external screening lab vendors.
- Ensuring lab is being built to exact specifications to ensure biopharmaceutical requirements are strictly employed.
- Ensuring the lab follows BSL-2 labs safety requirements.
- Selected all analyzers and instruments.
- Designed all performance qualification (PQ) studies for all equipment.
- Designed and approved all verification reports.
- Oversaw all instrument installation with IQ/OQ.
- Wrote with the team and approved over 85 SOPs and WI.
- Obtained CLIA Certification/FDA Certification.
- Selected LIS vendor and oversaw implementation of connectivity and configuration with all analyzers.
- Oversee EHS implementation and continuous monitoring.
- Negotiated contracts with external vendors.
- Supervised contractors and assigned them tasks.
- Direct report of 7 lab technicians, 3 contractors and over 30 indirect reports, including contractors.
Senior Laboratory Manager
REDWOOD TOXICOLOGY LABORATORY (Abbott Diagnostics Labs)
01.2020 - 12.2021
- Oversee all reference testing.
- Leads laboratory in providing drug test services to mostly government agencies across U.S., processing 85,000 laboratory specimens each week.
- Provides technical oversight and manages QC, QA, and QI laboratory systems to ensure compliance with CLIA, State of California, and other applicable regulatory requirements.
- Supervises and manages technical laboratory staff (licensed and unlicensed).
- Writes, maintains, and updates SOP manual.
- Manages training and competency evaluation of licensed and unlicensed laboratory staff.
- Maintains all applicable state and federal laboratory licenses and certificates and leads interactions with regulatory authorities.
- Oversees accurate and timely reporting of all laboratory testing results.
- Prepares laboratory for state and company inspection.
- Investigates results discrepancies via quality incident and CAPA.
- Works closely with laboratory directors to maintain smooth laboratory operation and accurate results, reporting in a timely manner.
- Oversee all aspects of assay validation from instrument qualification to full validation of Abbott’s platforms for COVID-19 testing (serology and molecular), one of the first testing laboratories for COVID-19 testing.
- Implemented wireless electronic temperature monitoring system (Vaisala).
- Implemented total Quality Management System (Agile) to manage all SOPs, CAPA, and Quality Incidents.
- Directly supervised 8 laboratory managers and over 300 indirect reports (laboratory technicians, specialists, scientists, supervisors and sales).
Medical Laboratory Director
MANACARE HEALTH LABORATORIES
01.2019 - 12.2020
- Acted as medical director of three ManaCare laboratories: Quality Metrics Laboratory (clinical chemistry and toxicology), Axis Professional Laboratories (clinical chemistry), and Beta Bioscience, LLC (pharmacogenomics).
- Set laboratory policies and procedures, as well as assessed capital equipment needs and initiated procurement procedures.
- Ensured that laboratories met CLIA and local regulatory requirements.
- Kept laboratory in inspection readiness level.
- Improved the laboratory's quality management program, including quality control procedures and variance reporting systems.
- Reviewed standard operating procedures in accordance with regulatory and accreditation requirements.
Medical Laboratory Director, Insight Diagnostics Laboratories
MANACARE HEALTH
01.2019 - 12.2019
- Clinical Toxicology and Pharmacogenomics Laboratory.
- Ensured adherence to CMS CLIA guidelines.
- Reviewed and wrote policies and procedures.
- Assisted with hiring qualified laboratory staff.
- Responsible for the administration of the technical and scientific operation.
- Planned, organized, and supervised the work of laboratory staff.
- Reviewed and investigated any (CAP discrepancy) for toxicology and Pharmacogenomics proficiency testing.
Director, Clinical Research Center Laboratory
MERIT DIAGNOSTICS PARTNERS
01.2011 - 12.2014
- Acted as key link between laboratory and university investigators.
- Provided expert recommendations for appropriate test utilization to investigators involved in national and international studies.
- Facilitated and managed CAP proficiency testing and maintained CAP proficiency compliance documentation.
- Participated in audits and quality assurance programs (validation report, SOPs, investigation report).
- Interacted with research sponsors in a collaborative manner.
- Established and supervised all aspects of the Quality Assurance (QA) program of CRCL core laboratory.
- The laboratory successfully passed the Joint Council Accreditation of Healthcare Organization (JCAHO) annual inspections, as well as CAP proficiency-testing national surveys.
- Member of the Institutional Review Board (IRB).
Director, Reference Laboratory, Phlebotomy and Central Receiving
VANDERBILT UNIVERSITY SCHOOL OF MEDICINE AND VANDERBILT MEDICAL CENTER
01.2011 - 12.2014
- Oversaw laboratory’s send-out testing, including central receiving with 70 staff members, with approximately 7,000 orderable tests per day.
- Managed laboratory’s day-to-day operation and CLIA compliance.
- Maintained and managed budget of $8 million.
- Coordinated with IT Department to establish outpatient order management system to replace outpatient paperwork requisition forms.
- Supervised and managed students, and trained fellows and residents.
- Coordinated with laboratory stakeholders to reduce laboratory expenditures by 5% while improving utilization by 10%.
- Consolidated and revised requisition process, and integrated into laboratory’s LIS system, reducing laboratory’s overall error rate by 50% while improving laboratory efficiency by 10%.
- Proposed and executed institution-wide physicians’ and nurses’ survey to address concerns raised by healthcare providers about test availability and turnaround time, revealing deficient laboratory-client relationships.
- Played leading role to address issues uncovered by survey through establishment of call center for clinical laboratories, satisfying 80% of calls within first minute while all remaining issues were resolved within 24 hours.
- Monitored key initiatives and strategies for front end (central receiving).
- Decreased pre-analytical error rates and processing times by 40%.
- Consolidated sent-out reference laboratory menu by bringing send-out tests in-house, complete with expense reduction, resulting in savings of $190,000.
- Participated in program to reduce send-out tests to outside reference laboratories by bringing tests in-house, resulting in eventual total savings of approximately $100,000.
- Consolidated send-out tests and negotiated new prices.
Assistant Director, Reproductive Endocrine Unit - Reference Laboratory
MASSACHUSETTS GENERAL HOSPITAL, DEPARTMENTS OF PATHOLOGY AND MEDICINE
01.2005 - 12.2008
- Co-directed center of excellence within laboratory.
- Served as liaison between outside investigators and laboratory and negotiated clinical trial protocols.
- Reviewed workload and priorities with laboratory director on a weekly basis.
- Assisted in evaluation of technician performance and training.
- Reviewed quality control data for each assay and supervised maintenance of QC records.
- Oversaw CAP proficiency testing and maintained CAP proficiency compliance documentation.
- Reviewed maintenance equipment logs and records with laboratory director.
Education
Ph.D. - Chemistry
CLEVELAND STATE UNIVERSITY
Cleveland, OhioMaster of Science - Clinical Chemistry
NORTHEASTERN UNIVERSITY
Boston, MassachusettsB.S. - Medical Laboratory Sciences
SANA’A UNIVERSITY
Sana'a, YemenSkills
- Lab Management
- Clinical Trials
- Reporting
- Documentation
- Operation
- Stakeholder relations
- Regulatory compliance
- Quality Assurance
- Technical Support
- Program Management
- Total Quality Management
- Continuous Improvement
- Capital Expenditure
- Operating expenses
- Contract negotiations
- Designing lab
- Building labs
- Research
- PCR- RT
- ci8200
- AU440
- AU2700
- Beckman 8500
- Cobas 6800
- LC-MS/MS
- m2000
- Abbott i-Alinity
Certification
Abbott Alinity-s, Agile, Visalia, LIS, Siemens Vista 1500, POC, Clinical and Forensic Toxicology, Immunology, Clinical Chemistry, Immunology, Reference Testing, Request for Proposal (RFP), CAP, AAB, PGX Transitional Software, Pathagility Software, Veeva, Compliance Wire (CW), BioFire Film Array, Microbiome Assay, Clinical Laboratory Director, Clinical Toxicology, National Registry of Clinical Chemists, NRCC-TC#-4023, Clinical Laboratory Director, Clinical Chemistry, National Registry of Clinical Chemists, NRCC-CC#-4023, Toxicological Technologist, National Registry of Clinical Chemists, NRCC-TT#-4800, Medical Laboratory Technologist, American Society of Clinical Pathologists, Board of Registry (ASCP), #3355, Clinical Laboratory Scientist, National Credentialing Agency for Laboratory Personnel (NCA), #748876, Tennessee, Clinical Laboratory Director, Clinical Chemistry, Medical Laboratory Board, Department of Health, #22373, New York, Clinical Laboratory Director, Certificate of Qualifications in Clinical Chemistry, Clinical Toxicology, Diagnostic Immunology, Molecular Genetics, New York State Department of Health, #CQP79350, Louisiana, Clinical Laboratory Scientist (Lab Director level), Louisiana State Medical Board of Examiners, #323329, California, Laboratory Director, Clinical Toxicology, California Laboratory Field Services, #DRJ-02151684, Florida, Laboratory Director, Clinical Chemistry and Toxicology, Florida Department of Health, #DI 53787
Professional Development
- Management Development Program: Develop Your Managerial Mindset, UPenn Wharton - Executive Education Program, 01/01/23
- Method Decision Charts for Sigma Metric, 01/01/22
- Crucial Conversations, Abbott Talent Development, 01/01/21
- Abbott Rapid Diagnostics Six Sigma Yellow Belt Program, 01/01/20
- Abbott Alinity Ci-Series and m2000/R T (COVID Analyzers), 01/01/20
- Fundamentals of Molecular Pathology, AACC, 01/01/15
- Point of Care Specialist, AACC, 01/01/15
- Statistical Methods for Clinical Laboratorians Certificate, AACC, 01/01/15
- Principles of Clinical Toxicology, AACC, 01/01/15
- Using Tandem Mass Spectrometry, AACC, 01/01/15
- Investigator's Responsibilities, 01/01/14
- Tissue Banking and Repositories for Research, Vanderbilt, 01/01/13
- Community-Based Recruiting for Clinical Research, Vanderbilt, 01/01/13
- Data Safety Monitoring and Regulatory Requirements, Vanderbilt, 01/01/12
- Research on Biological Specimens, Vanderbilt, 01/01/12
- The Importance of Data Security, Vanderbilt, 01/01/11
- Tissue Banking: Guidelines, Laws, and Practice, Vanderbilt, 01/01/11
- Budgeting for Clinical Trials, Vanderbilt, 01/01/11
- Henry Ford Production System Lean Quality Training Program, Vanderbilt, 01/01/10
- What Goes on Behind Closed Doors: The IRB Committee Meetings, Vanderbilt, 01/01/09
- FDA Citations and Warning Letters, Vanderbilt, 01/01/09
- Shipping Dangerous Goods Training (Class 6.2 Infectious Substances, Class 9 Miscellaneous Goods), MGH, 01/01/07
- The Health Insurance Portability and Accountability Act, 01/01/06
- Partners Program in the Responsible Conduct of Research, MGH, 01/01/05
Affiliations
- Journal of Toxicology Editorial Board, 01/01/15, Current
- Tennessee Academy of Science, 01/01/14, 12/31/19
- American Association for Clinical Chemistry Academy (FAACC), 01/01/14, Current
- Academy of Clinical Laboratory Physicians and Scientists, 01/01/06, Current
- American Association for Clinical Chemistry (AACC), 01/01/93, Current
Professorial Experience
- Adjunct Assistant Professor, COLUMBIA COMMUNITY COLLEGE, Columbia, Tennessee, 01/01/15, 12/31/19
- Assistant Professor of Pathology, VANDERBILT UNIVERSITY, School of Medicine, Department of Pathology, Microbiology and Immunology, Nashville, Tennessee, 01/01/11, 12/31/14
- Director, VANDERBILT UNIVERSITY MEDICAL CENTER, Nashville, Tennessee, 01/01/09, 12/31/14
- Instructor, Capstone Seminar, VANDERBILT UNIVERSITY SCHOOL OF MEDICINE, DEPARTMENT OF PATHOLOGY, MICROBIOLOGY, AND IMMUNOLOGY, Nashville, Tennessee, 01/01/09, 12/31/13
- Instructor of Pathology, VANDERBILT UNIVERSITY, Nashville, Tennessee, 01/01/08, 12/31/11
- Instructor of Pathology and Medicine, HARVARD MEDICAL SCHOOL, Boston, Massachusetts, 01/01/05, 12/31/08
- Visiting Fulbright Scholar, HARVARD MEDICAL SCHOOL, Boston, Massachusetts, 01/01/03, 12/31/04
- Assistant Professor, SANA’A UNIVERSITY, Sana'a, Yemen, 01/01/99, 12/31/03
Personal Information
Citizenship: United States of America
Timeline
CLIA Clinical Laboratory Director
CREATVBIO
05.2024 - Current
Clinical Laboratory Director
SERES THERAPEUTICS
01.2021 - 12.2023
Senior Laboratory Manager
REDWOOD TOXICOLOGY LABORATORY (Abbott Diagnostics Labs)
01.2020 - 12.2021
Medical Laboratory Director
MANACARE HEALTH LABORATORIES
01.2019 - 12.2020
Medical Laboratory Director, Insight Diagnostics Laboratories
MANACARE HEALTH
01.2019 - 12.2019
Director, Clinical Research Center Laboratory
MERIT DIAGNOSTICS PARTNERS
01.2011 - 12.2014
Director, Reference Laboratory, Phlebotomy and Central Receiving
VANDERBILT UNIVERSITY SCHOOL OF MEDICINE AND VANDERBILT MEDICAL CENTER
01.2011 - 12.2014
Assistant Director, Reproductive Endocrine Unit - Reference Laboratory
MASSACHUSETTS GENERAL HOSPITAL, DEPARTMENTS OF PATHOLOGY AND MEDICINE
01.2005 - 12.2008
Master of Science - Clinical Chemistry
NORTHEASTERN UNIVERSITY
B.S. - Medical Laboratory Sciences
SANA’A UNIVERSITY
Ph.D. - Chemistry
CLEVELAND STATE UNIVERSITY
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