Mahyar Sameti
Principal Quality Control Analyst @eGenesis
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WORK HISTORY
Principal Quality Control Analyst @eGenesis
Cambridge, MA, US
Lead method transfer and qualification activities in support of our pre-clinical and clinical programs-) Execute QC testing to support release and stability analysis for drug substance and drug product-) Manage method qualification and release testing conducted at contract testing organizations-) Conduct testing investigations and deviations to support root cause analysis and corrective and preventative actions, as required-) Implement QC systems and procedures compliant with cGMP-) Manage programs for critical laboratory reagents, assay controls/reference standard, and equipment-) Independently analyze and summarize data in technical reports and presentations-) Author, review, and/or approve data, logbooks, SOPs, CoAs, analytical methods, protocols, reports, deviations, and other quality records-) Maintain the QC Unit in a state of compliance and inspection readiness
EDUCATION
Islamic Azad University, Science And Research Branch
Bachelor's degree, Biomedical/Material Engineering
Florida Institute of Technology
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
Islamic Azad University, Science And Research Branch
Master's degree, Biomedical/Medical Engineering
ABOUT MAHYAR SAMETI
With a solid foundation in biomedical engineering, my career focuses on leveraging cutting-edge CRISPR technologies to ensure the highest quality in therapeutics. My role involves meticulous oversight of quality control (QC) sample processes, including routine and non-routine testing, which is pivotal for the safe and effective use of medical interventions. Skills in flow cytometry, aseptic techniques, and cell culture, developed through hands-on experience, are central to my daily responsibilities.I am passionate about contributing to transformative gene-editing treatments, where my expertise supports robust protocol development and sample management. Coordinating with external testing laboratories and analyzing data trends are key aspects of my work, aligning with a commitment to innovation and excellence in medicine. My dedication to advancing healthcare solutions is reflected in the strategic implementation of Good Clinical Practice (GCP) principles and a comprehensive approach to quality control.
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