QC Lab Assistant, GMP, Shared Resource Core Facility (Good Manufacturing Practices)
About The Position
Memorial Sloan Kettering Cancer Center is hiring a QC Lab Assistant for its GMP Shared Resource Core Facility in New York, NY. The role builds, compiles, reviews, and trends test-result details to support release of cell and gene therapy products manufactured within the facility. The assistant partners with Manufacturing, Process Development, and Quality Assurance teams to support receipt, handling, processing, and testing of Quality Control samples throughout the manufacturing lifecycle. The position plans and coordinates QC laboratory activities and maintains accurate QC documentation, test records, and result logs for each manufactured product in compliance with GMP requirements and the established quality control program. It also supports cell therapy operations and patient infusion activities, quality systems, and data management. Additional work includes analytical development assay activities, such as assay qualification and method optimization, to support product characterization and release testing.
Requirements
- Bachelor’s degree or equivalent in Biology, Chemistry, Pharmaceutical Sciences, Biochemistry, or another related scientific field.
- Three years of experience in the position offered or a related position.
- Three years of experience with molecular biology techniques, including qPCR, PCR, flow cytometry, DNA extraction, and cell-based assays.
- Three years of experience with gene editing techniques, including CRISPR-mediated gene knockout and single-cell cloning.
- Three years of experience drafting SOPs and designing and planning experiments.
- Three years of experience in data analysis, interpretation, and trending.
- Three years of experience maintaining laboratory equipment and documenting results under GLP conditions.
- Three years of experience with Microsoft Word, PowerPoint, Excel, FlowJo, GraphPad Prism, and SnapGene.
Responsibilities
- Build, compile, review, and trend test-result details to support release of cell and gene therapy products.
- Partner with Manufacturing, Process Development, and Quality Assurance teams on receipt, handling, processing, and testing of Quality Control samples throughout the manufacturing lifecycle.
- Plan and coordinate QC laboratory activities.
- Maintain QC documentation, test records, and result logs for each manufactured product in compliance with GMP requirements and the quality control program.
- Support cell therapy operations and contribute to patient infusion activities, quality systems, and data management activities.
- Perform and support analytical development assay activities, including assay qualification and method optimization, for product characterization and release testing.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
