Gene Therapy Analyst

A company is looking for a Contract, Analytical Science & Technology - Gene Therapy. Key Responsibilities Manage change controls, deviations, and investigations within the Quality Management System (QMS) Oversee analytical data and data analysis for routine release and stability testing Assist with investigating commercial product complaints/issues across manufacturing sites Required Qualifications Master's in molecular biology, virology, biochemistry, or related field with a minimum of 5 years of relevant experience Knowledge of analytical methods for gene therapy or biologics, particularly potency assays Experience with change controls and investigations within a Quality Management System Strong understanding of CMC analytical and regulatory requirements Hands-on experience with laboratory operations and quality metric programs

Feb 20, 2025 - 16:20
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Gene Therapy Analyst
A company is looking for a Contract, Analytical Science & Technology - Gene Therapy. Key Responsibilities Manage change controls, deviations, and investigations within the Quality Management System (QMS) Oversee analytical data and data analysis for routine release and stability testing Assist with investigating commercial product complaints/issues across manufacturing sites Required Qualifications Master's in molecular biology, virology, biochemistry, or related field with a minimum of 5 years of relevant experience Knowledge of analytical methods for gene therapy or biologics, particularly potency assays Experience with change controls and investigations within a Quality Management System Strong understanding of CMC analytical and regulatory requirements Hands-on experience with laboratory operations and quality metric programs