Abhilash Tripathi
Scientist Ii @FUJIFILM Biotechnologies
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WORK HISTORY
Scientist Ii @FUJIFILM Biotechnologies
Bryan–College Station, TX, US
Served as Analytical Lead for an AAV program, leading a team of 8 analytical scientists to establish and qualify analytical methods supporting GMP execution. Led assay qualification/validation activities by authoring protocols, executing studies, and preparing reports in alignment with ICH Q2(R2) principles to support GMP and phase-appropriate use. Partnered cross-functionally with Process Development (Upstream/Downstream), Manufacturing, QC, and QA to drive method transfer readiness, troubleshoot execution risks, and enable timely batch testing. Enabled completion of the first GMP run within 10 months of method transfer and assay qualification, supporting IND-enabling timelines and CMC deliverables. Supported broader AAV analytical workflows (e.g, qPCR/ddPCR, assay controls strategy, system suitability, reportable range) to ensure robust release and in-process decision making. Implemented NGS-based assays/workflows for identity or adventitious agent applications; contributed to bioinformatics data processing and reporting.
EDUCATION
Jaypee University of Information Technology
Master's Degree, Biotechnology
South Dakota Mines
Graduate Student, Chemical and Biological Engineering
Kendriya Vidyalaya
High School
SKILLS
ABOUT ABHILASH TRIPATHI
Analytical development scientist in biotech with 8+ years of experience across industry and research. I lead cross-functional delivery for gene therapy programs—translating data into decisions, aligning stakeholders, and building repeatable processes that reduce risk and improve quality.Currently, I am an Analytical Lead managing a team of 8 scientists and partnering with Process Development, Manufacturing, QC, and QA to enable GMP execution. Recent work includes helping deliver a first GMP run within 10 months and supporting an IND filing.
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