QC & Analytics Associate, Cell & Gene Therapy

Columbia University Irving Medical Center; New York (NY); On-site; USD 66,000 - 80,000; Full time

Job summary

The Quality Control and Analytics Associate role at Columbia Institute for Cell Engineering and Therapy (CICET) supports development and validation of analytical and QC assays for cell and gene therapy products. You will manage external testing and ensure compliance with cGMP data integrity and quality systems.

Collaborating with Process Development, GMP Manufacturing, Quality Assurance, and external labs, you will drive product development, release, and ongoing quality oversight while

Qualifications

• Bachelor's degree or equivalent in education and experience.
• Minimum 1 year of relevant lab experience in mammalian cell culture, molecular biology, analytical testing, or QC environments.
• Hands-on proficiency with qPCR, dPCR, PCR, and nucleic acid handling.
• Ability to analyze sequence data and perform DNA/RNA sequence alignments.
• Strong computer proficiency with standard business apps (Office, Teams, Zoom).

Responsibilities

• Develop, qualify, and execute analytical and molecular assays (qPCR/dPCR).
• Coordinate external testing, sample shipments, chain-of-custody, and results documentation.
• Perform release, in-process, characterization, and stability testing per cGMP and data integrity requirements.
• Prepare and manage controlled documents; use eQMS/LIMS for recordkeeping.
• Collaborate with Process Development, GMP Manufacturing, QA, and external labs to align testing priorities and timelines.

Skills

qPCR / dPCR

Molecular biology techniques

Cell culture

Sequence analysis

Documentation & recordkeeping

Collaboration & communication

Education

Bachelor's degree or equivalent in education and experience

Tools

Electronic quality management systems (eQMS)

LIMS

Microsoft Office

Job description

The Quality Control and Analytics Associate role at Columbia Institute for Cell Engineering and Therapy (CICET) supports development and validation of analytical and QC assays for cell and gene therapy products. You will manage external testing and ensure compliance with cGMP data integrity and quality systems.

Collaborating with Process Development, GMP Manufacturing, Quality Assurance, and external labs, you will drive product development, release, and ongoing quality oversight while