Quality Control and Analytics Associate, CICET

Columbia University Irving Medical Center; New York (NY); Vor Ort; USD 66.000 - 80.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

qPCR / dPCR

Molecular biology techniques

Cell culture

Sequence analysis

Documentation & recordkeeping

Collaboration & communication

Ausbildung

Bachelor's degree or equivalent in education and experience

Tools

Electronic quality management systems (eQMS)

LIMS

Microsoft Office

Jobbeschreibung

Grade 103

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $66,300 - $80,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Quality Control and Analytics Associate supports the development, qualification, validation, and execution of analytical and quality control (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. The Associate collaborates closely with Process Development, GMP Manufacturing, Quality Assurance, and external testing laboratories to support product development, release, and ongoing quality oversight.

Responsibilities

Responsibilities include:

• Analytical Method Development & Molecular Biology: Develop, optimize, qualify, and execute analytical and molecular assays, including qPCR/dPCR, cloning, gene and base-editing applications, and nucleic acid isolation and preparation. Perform DNA and RNA sequence analysis, alignment, and interpretation using bioinformatics tools.
• External Testing Coordination: Manage external biosafety and contract testing activities, including test request submissions, sample shipment coordination, chain-of-custody tracking, and review and documentation of final results.
• Quality Control & Compliance: Perform release, in-process, characterization, and stability testing in accordance with cGMP, GDP, and data integrity requirements. Support quality investigations, deviations, out-of-specification (OOS) results, and corrective and preventive action (CAPA) activities.
• Documentation & Laboratory Systems: Author, review, and maintain controlled documents, including SOPs, test methods, protocols, and reports. Utilize electronic quality management systems, laboratory information systems, and vendor portals while ensuring accurate, timely, and compliant recordkeeping.
• Laboratory Operations & Cross-Functional Collaboration: Maintain QC laboratory organization, inventory, and equipment readiness. Partner closely with Process Development, GMP Manufacturing, Quality Assurance, and external testing laboratories to communicate testing priorities, report findings, identify risks, and support project timelines.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience 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, including experience with digital platforms, document repositories, and standard business applications (Microsoft Office, Teams, Zoom).

Preferred Qualifications

• 2+ years of relevant experience in a cell and gene therapy, analytical development, or cGMP/QC laboratory setting.
• Specialized experience in cell and gene editing workflows (CRISPR/base-editing) and construct verification.
• Practical experience with flow cytometry, human cell manipulation, and cellular therapeutic product testing.
• Prior experience coordinating testing with external contract/biosafety laboratories or working within electronic quality management systems (eQMS / LIMS).

Other Requirements

• Medical clearance and participation in applicable medical surveillance programs, if required.
• Potential bloodborne pathogen exposure
• Successful completion of all required institutional compliance, regulatory, and systems training.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.