Cell & Gene Therapy QC Analytics Associate

Columbia University in the City of New York; New York (NY); Vor Ort; USD 66.000 - 80.000; Vollzeit

Zusammenfassung

Columbia University in the City of New York is seeking a Quality Control and Analytics Associate to support the development, qualification, validation, and execution of analytical and QC assays for cell and gene therapy products at the Columbia Institute for Cell Engineering and Therapy (CICET).

This role manages external testing activities, applies expertise in molecular biology and sequence analysis, and ensures compliance with cGMP standards, data integrity requirements, and quality systems.

Qualifikationen

• Bachelor's degree or equivalent required.
• Minimum of 1 year of relevant laboratory experience in mammalian cell culture, molecular biology, analytical testing, or QC environments.
• Hands-on proficiency with cell culture and molecular biology techniques, including qPCR, dPCR, PCR, and nucleic acid handling.
• Demonstrated ability to execute laboratory aseptic techniques, analyze sequence data, and perform DNA/RNA sequence alignments.
• Strong computer proficiency with standard business applications (Microsoft Office, Teams, Zoom).

Aufgaben

• Develop, optimize, qualify, and execute analytical and molecular assays, including qPCR/dPCR, cloning, gene editing, and nucleic acid isolation.
• Manage external biosafety and contract testing activities, including test requests, sample shipments, chain-of-custody, and result review.
• Perform release, in-process, characterization, and stability testing in line with cGMP, GDP, and data integrity requirements.
• Author, review, and maintain controlled documents (SOPs, test methods, protocols, reports) and use QMS/LIMS systems.
• Maintain QC lab organization, inventory, and equipment readiness; coordinate with cross-functional teams on testing priorities.

Kenntnisse

Molecular biology

qPCR/dPCR

Cell culture

Data analysis

Documentation/compliance

Ausbildung

Bachelor's degree

Tools

qPCR

dPCR

PCR

Nucleic acid handling

Jobbeschreibung

Columbia University in the City of New York is seeking a Quality Control and Analytics Associate to support the development, qualification, validation, and execution of analytical and QC assays for cell and gene therapy products at the Columbia Institute for Cell Engineering and Therapy (CICET).

This role manages external testing activities, applies expertise in molecular biology and sequence analysis, and ensures compliance with cGMP standards, data integrity requirements, and quality systems.