Sarah Al-Gassimi
Clinical Research Associate at Morphogenesis, Inc.- Claim this Profile
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Bio
Experience
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Morphogenesis, Inc.
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United States
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Biotechnology Research
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1 - 100 Employee
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Clinical Research Associate
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May 2021 - Present
Tampa, Florida, United States Responsible for trial management from startup through closeout including trial design, feasibility, site qualification and initiation, regulatory compliance, and data management. Overall clinical operations responsibilities also include IRB submissions, GCP compliance, trial conduct and management, CRO/CRA management, and trial logistics.
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Bioprocessing Operations Manager
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May 2021 - Present
Tampa, Florida, United States Responsible for operational processes such as production operations, inventory management, equipment management, and all associated documentation. I work closely with Quality Control, Quality Management, Clinical Operations, and Regulatory Affairs to ensure objectives are met in accordance with applicable rules and regulations. I also support interactions with CMOs, CRO partners, and clinical sites.
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Production Manager, Biologics
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Dec 2018 - May 2021
Tampa, Florida, United States Responsible for production associated functions supporting early-phase clinical product manufacturing within the Company's regulated Bioprocessing Facility.
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Production Associate, Biologics
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Aug 2017 - Dec 2018
Tampa, Florida, United States Successfully performed upstream production, downstream production, and aseptic fill-finish processes. Responsible for ensuring all activities and procedures performed are compliant with Morphogenesis Quality Management System.
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Florida Institute of Technology
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United States
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Higher Education
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700 & Above Employee
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Research Assistant
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Mar 2016 - Aug 2016
Melbourne, Florida Area Performed laboratory techniques including, but not limited to protein & DNA extraction, western blot, and agarose gel electrophoresis. Assisted in writing protocols following IACUC guidelines. Managed laboratory purchasing and inventory processes.
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Johns Hopkins Aramco Healthcare (JHAH)
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Saudi Arabia
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Hospitals and Health Care
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700 & Above Employee
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Intern
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2012 - 2013
Dhahran, Saudi Arabia Successfully performed laboratory work assignments including collecting and analyzing specimens for blood bank (including both donor area activities and transfusion medicine), microbiology (bacterial, fungal, viral identification, and antibiotic sensitivity testing), and immunology/serology. This clinical laboratory training program was performed at a CAP-accredited laboratory in good standing.
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Education
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Florida Institute of Technology
Master's degree, Biotechnology -
Imam Abdulrahman Bin Faisal University
Bachelor's degree, Clinical Laboratory Science/Medical Technology/Technologist