Opportunity Description
Reporting to the Director of Quality Control, the QC Scientist will be responsible for the development, execution, and analysis of flow cytometry assays. Familiarity with additional testing modalities, including ELISA-based assays, is required to provide quality oversight of manufacturing and Quality Control activities, such as in-process and final product testing, to ensure results meet defined specifications prior to release.
All assay development and execution must comply with cGMP regulations and internal Standard Operating Procedures (SOPs). This role requires extensive experience with bioanalytical assays and a strong working knowledge of GMP requirements for late-stage and commercial cell therapy products in the United States.
Key Responsibilities
Coordinate and perform cGMP- compliant testing for product release, in-process controls, and stability samples
Ensure QC equipment is properly qualified, maintained, and calibrated in accordance with...
All assay development and execution must comply with cGMP regulations and internal Standard Operating Procedures (SOPs). This role requires extensive experience with bioanalytical assays and a strong working knowledge of GMP requirements for late-stage and commercial cell therapy products in the United States.
Key Responsibilities
Coordinate and perform cGMP- compliant testing for product release, in-process controls, and stability samples
Ensure QC equipment is properly qualified, maintained, and calibrated in accordance with...