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...