Experienced clinical research and technical director with over 20 years of success in clinical lab testing, developing DNA/RNA, cell and gene therapies for immunotherapy trials, and the biotech/pharmaceutical sectors. Proficient in FDA-approved Phase 1/II trials, handling biological samples, and overseeing cell therapy processes. Proven track record in effectively managing lab operations, manufacturing, equipment, and facility launches. Skilled in mentoring young talents in life sciences.
· Coordinated laboratory activities to support the responsibilities of laboratory personnel, maintaining and overseeing proficiency in COVID-19 sampling, testing, and reporting results.
· Supported process monitoring during internal and external audits, as well as regulatory processes.
· Coordinated a national-level project focused on epidemiological and clinical studies of childhood cancer, specifically Fanconi Anemia, funded by a $12 million NIH grant over 9 years.
· Conducted genetic and molecular biochemical analyses on DNA repair genes, involving research on DNA repair and cancer in both mice and humans; purified and characterized DNA repair genes using Fast FPLC.
· Co-authored and published two research articles in peer-reviewed scientific journals.
· Managed a $3.2 million budget for producing and selling health products and research diagnostic kits to local and international customers and vendors.
·Developed research diagnostic kits and performed statistical analyses of research assay development, including:
· Coordinated clinical studies on heart patients in collaboration with the Cleveland Clinic.
· Published a study on "Heart Disease and MPO as a Biomarker" in the New England Journal of Medicine
· Published study on "Heart disease and MPO as a biomarker" in the New England Journal of Medicine.
· Coordinated 2.3 -million dollar grant for providing cancer gene therapy (HLA-B7/b2-microglobulin gene) for cancer patients; Performed genetic analyses for HLA genes and immunochemical analyses including ELISA for cytokine production, FACS (Fluorescence-Activated Cell Sorting), cell isolation techniques, and cell proliferation studies.
· Conducted FDA-approved clinical trails (phase I/II) with cancer patients.
Cell tissue culture & ELISA, FACS
Manufacturing of gene and cell therapies, and Clinical trials (phase I/II)
Analytics tools and Analytical testing processes
Process control and Product release
Content creation/publications
External/internal audits and regulatory processes
GCP/GLP/cGMP regulations
Writing & Reviewing equipment qualification/maintenance
· Google-Certified Project Management Professional (2024)
· Google-Certified Data Analyst (2023)
· CPR/AED, Basic First Aid, American Heart Association, Oregon (2023)
· Certified Environmental Health and Safety Specialist, OSHA Academy, Oregon (2019)
· Registered Medical Assistant, American Medical Technologists, Springfield, Illinois (2013)
· Google-Certified Project Management Professional (2024)
· Google-Certified Data Analyst (2023)
· CPR/AED, Basic First Aid, American Heart Association, Oregon (2023)
· Certified Environmental Health and Safety Specialist, OSHA Academy, Oregon (2019)
· Registered Medical Assistant, American Medical Technologists, Springfield, Illinois (2013)