Opportunity Description
Description
Position Summary
The Experienced Quality Control Analyst II will be responsible for supporting the manufacture of AAV Viral Vector Gene Therapy Drug Products through the performance of Analytical/Bioanalytical testing of starting materials, in-process/finished drug product, stability samples, as well as process characterization and development projects.
Essential Position Requirements
• Performs Analytical/Bioanalytical testing of starting materials, in-process/finished drug product and stability samples, primarily utilizing analytical test methods, product and residual content assays, and/or other compendial methods as required.
• Performs product characterization assays to support product development and PPQ campaigns.
• Supports method qualification, method validation and transfer to the QC laboratories, as needed.
• Monitors lab equipment for instrumentation issues or calibration needs.
• Provides input and authorship of document revisions rela...
Position Summary
The Experienced Quality Control Analyst II will be responsible for supporting the manufacture of AAV Viral Vector Gene Therapy Drug Products through the performance of Analytical/Bioanalytical testing of starting materials, in-process/finished drug product, stability samples, as well as process characterization and development projects.
Essential Position Requirements
• Performs Analytical/Bioanalytical testing of starting materials, in-process/finished drug product and stability samples, primarily utilizing analytical test methods, product and residual content assays, and/or other compendial methods as required.
• Performs product characterization assays to support product development and PPQ campaigns.
• Supports method qualification, method validation and transfer to the QC laboratories, as needed.
• Monitors lab equipment for instrumentation issues or calibration needs.
• Provides input and authorship of document revisions rela...
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