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
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