Fatemeh Fazlhashemi

WORK HISTORY

EDUCATION

ABOUT FATEMEH FAZLHASHEMI

Experienced Research Associate with beneficiary of grant awards and demonstrated multidisciplinary history of working in the Nano-Biotechnology / Oncology / Immunology and Clinical Genomic Medicine workflows. Skilled in immunoassay systems, Cell Culture, Molecular Biology and Immunotherapy Techniques, training and leading roles at Modifi Bio, Bio-Techne, CaroGen Corporation, UConn Health Technology Incubation Program, and spin-off from Yale University School of Medicine. Assisted in conducting mice immunogenicity and efficacy studies, dosing injections by viral vector and administered via IP, IV,IM, SC. Western blot, ELISA, FACS antibidy staining, flow cytometry, collecting and harvesting spleens, lymphocyte culture, live animal work of mice assessment in BSL-2 environment, and produced VLV cancer vaccines at large scale. Strong expertise in pharmacokinetics (PK), toxicokinetic (TK), and regulatory submissions. Proven record of contributing to submission-ready documents (IND, NDA, BLA, IB), SEND datasets, and PK/TK report authoring. Adept in interpreting TK data for exploratory toxicology studies, scientific data QC, and ensuring alignment with regulatory requirements. Skilled at cross-functional collaboration, lab operations, and process improvement in GLP/GMP-compliant environments.Processing and data generation for COVID-19 testing at the clinical genomics laboratory (Genomic Medicine-The Jackson Laboratory) to maintain all documentation required for operation under CLIA/CAP certification, including review and writing of SOPs as necessary. Successfully sustained CLIA/CAP certification, including competency and proficiency assessments, training and safety, HIPPA and CITI.