My brief resume'

1. Profile
Chief Scientific Officer, Laboratory Director with 15 + years of experience in Quality
management systems, clinical laboratory regulatory affairs and accreditation.
Extensive knowledge of workplace drug testing in addition to clinical chemistry and
toxicology. Highly skilled in successfully resolving challenges towards laboratory
licensing and regulatory issues.
• Audit compliance
• Root cause analysis
• Metrics development
• Quality documentation
• Regulatory compliance
• Validation management
Experience
Chief Scientific Officer, Laboratory Director, Captiva Lab LLC. Charlotte NC
2014-present
• Oversee leadership responsibilities for overall designing, implementing drug
monitoring programs for High complexity reference laboratories, assuring
CLIA COLA /CAP federal and state compliance.
• Saved 500,000 /year on reagents cost with procedure improvement, designing
unique methods and building international collaborations.
• Regulates affairs responsibly through data Interpretation and oversight of
regulatory requirements ( lab inspections and audits, state licenses, personal
trainings, credentials and licenses, CLIA /COLA/CAP accreditation, DEA
license and SOPs) while implementing corrective actions in response to
deficiencies.
410-868-8343
m.tyag001@gmail.com
https://www.linkedin.com/in/manoj-tyagi-4b11459
Manoj Tyagi, Ph.D. F AACC/ FACB, NRCC

2. • Manage to start up of genetic testing and molecular diagnostic lab, Blood
testing for clinical chemistry screening lab: fitting out lab space, purchasing
instruments hiring personal, coordinating test validations, adding genetics and
Blood testing to CLIA and CAP accreditation.
Remote based part time Laboratory director and lab consultant 2014- present
• Pain Management Centre, Chicago IL
• Acacia Mental health Clinic, Milwaukee, WI
• Captiva Lab LLC, Houston Tx
• Advance wellness Sports & Spine, Davenport, Iowa.
• WaveLight Lab, LLC. Boca Raton FL
Board certified Clinical Chemist and Toxicologist (NRCC)
Active member AACC and licensed. Qualified for a laboratory director of high
complexity testing at 42 CFR 493.1443(b)(3)(i).
Expertise in preparing Moderate and High complex facility towards FDA
based regulatory compliance annual inspections as well as skilled technical
consultation with setting up startup facility for Pharma based clients (remote
based and onsite audits)
Clinical Lab Supervisor, Integra Labs. April 2014- Sept 2014
Responsible for day to day supervision of assay performance QA, QC,
Management and FDA based clinical regulatory compliance for urine and oral
fluid drug screenings by advance high throughput screening assays for high
complexity testing facility at 42 CFR 493(b)(3)(i).
• Working under GLP, GMP;
• Maintaining quality system regulation;
• High Proficiency - Multiplex Chemistry Analyzers, Olympus AU 480,
640, 5400; CI 8200 Abbott
• Method update and validationLCMS/MS – Schimadzu 8040, AB Sciex
BS 3200 QTRAP, AB triple
quad 4500, 5500.

3. • Extensive knowledge of clinical process development and routine drug
screening by high
throughput Immunoassay and LC MS/MS. Blood based Clinical
Chemistry, offering PGX/MDX and Clinical Toxicology services.
• Lab Manager, United Toxicology LLC. Sept 2013 - April 2014
For designing, implementing drug monitoring programs for physician
in-office laboratories, assuring CLIA COLA federal and state
compliance. My main responsibility for entire lab management
including LCMS screening their method validation, optimization and
report precision and accuracy based CLIA regulatory compliance
toward urine drug toxicology testing.
• Clinical Lab Supervisor, AvuTox LLC May 2013 - Nov 2013.
Responsible for day to day supervision of assay performance QA, QC,
Management and FDA based clinical regulatory compliance for urine
and oral fluid drug screenings by advance high throughput screening
assays for high complexity testing facility at 42 CFR 493(b)(3)(i).
ACADEMIC EMPLOYMENT
• Post-doctoral research fellow Jan 2009-April 2013:
Department of Pulmonary Medicine and
Critical Care and Anatomy and Neurobiology at
University of Maryland, School of Medicine, Baltimore, Maryland. As part of
a leading research team in the field of airway smooth muscle biology and
GPCR coupled PKA activation and signaling pathways -R01 NIH sponsored
Granted project.
• Post-doctoral research fellow: 2007-2009 Department of Biochemistry and
Molecular Biology, University of South Alabama, under the supervision of
Prof. William T Gerthoffer, Chairman Dept. of Biology and Molecular
Biology

4. • Research visiting fellow: 2005-2007 University of Puerto Rico – Humacao,
Puerto Rico with Prof. Carman Hernandez, PhD. On an NIH funded project
in PRABRE “The influence of the nervous system on mucociliary activity”.
PROFESSIONAL AFFILIATIONS
• Guest lecture “PKC signaling and activation of macrophage and role
of pro-inflammatory cytokines in asthma” 2012. School of Medicine,
University of Maryland, Baltimore.
• Lunch presentation on “Integration & implementation of fully
Automated Sample preparation for Mass spectrometry” at MSACL
meeting 2017.
• Invited Speaker “ Next Generation Mass Spec Approach Towards
Clinical Toxicology and Therapeutic Drug Testing from Oral Fluid
Matrix” at CPSA 2017.
• Invited Speaker “ Lab Developed Automated Testing Approach
Towards Clinical Toxicology and Therapeutic Drug Testing from
Oral Fluid Matrix” at North East Association of Forensic Science
NEAFS, 2017.
• Invited speakers, “ Next Generation Mass Spec Approach Towards
Clinical Toxicology and Therapeutic Drug Testing from Oral Fluid
Matrix” Society of Forensic Toxicology SOFT 2018.
• National Registry for Clinical Chemists http://www.nrcc6.org
• American Association of Clinical Chemistry AACC.org
• American College Medical Toxicology acme.net
• Society of forensic Toxicology http://soft-tox.org

5. PEER REVIEWED
• Member, Board of Directors, National Registry Clinical Chemists
(NRCC).
• Ambassador, Admin, North Carolina Section, Artery (AACC).
• Associate editor, J of Biochemistry letters, (Bioinfo press, India)
• Member editorial Board, Journal of Chemistry, Biochemistry and
Molecular Biology (SJI California, USA).
Reviewer, Scientific abstracts, and clinical toxicology sessions at, Society of
Forensic Toxicology.
Reviewer, Cell health and Cytoskeleton, (Dove press, New Zealand).
Reviewer, Therapeutic Advances in Respiratory Disorders (Sage pub. UK).
Reviewer, J Applied Laboratory Medicine (AACC publication). Reviewer,
Lab Test online (AACC online publication).
Recent publications:
• https://www.aacc.org/community/aacc-academy/publications/
scientific-shorts/2019/consideration-in-drug-testing-for-addiction-
treatment by Manoj Tyagi, PhD.
• https://www.aacc.org/community/aacc-academy/publications/
scientific-shorts/bios/t-to-z/manoj-tyagi
• https://myemail.constantcontact.com/Shimadzu-cordially-invites-you-
to-visit-with-us-at-MSACL-in-Palm-Springs-.html?
soid=1116382867787&aid=MrcVKu9PX-0
• https://www.msacl.org/workshop_profiles_2017US.php?id=11