Job Description

Staff Associate I

Position Description

The Columbia Initiative in Cell Engineering and Therapy (CICET) is seeking a highly motivated Staff Associate I.
The Staff Associate I, reporting to the Associate Director of PD and GMP manufacturing, will collaborate with the CICET QC, Facility Management, and QA teams, as well as research teams, to scale and translate research production processes for cell and gene therapy products into a robust cGMP manufacturing process. The specialist will produce cell therapy drug products in a GMP environment to ensure timely, cost-effective, and high-quality products for Phase 1/2a clinical trials.

Responsibilities:

• Functional Knowledge - Knowledge in cell and gene therapy process development, GMP manufacturing, documentation and compliance, and analysis of cell and gene therapy drug substances and products.
• Problem Solving - Utilizes analytical skills to solve moderately complex problems, GMP training, and experience using sound judgment and precedent.
• Decision Making/Autonomy - Works within guidelines from the Associate Director for PD and GMP operations to carry out assigned duties in the design of experiments, project needs, conduct of experiments, and data analysis.
• Technical Expertise - Perform process development experiments and GMP manufacturing in addition to maintaining PD reagents and equipment to ensure efficient day-to-day operations.
• Communication - Participate in planning and discussion of laboratory projects and data with the manager, contribute to experimental design and provide advice on methodology. Accurately document batch activities in real-time using GMP-compliant systems and controlled documents.

Qualifications

• Bachelor’s degree in Biology, Biotechnology, Cell Biology, Biochemistry, Bioengineering, or a related field and 4 years’ experience recommended.
• Hands-on experience in CAR-T or viral vector process development and/or GMP cell manufacturing.
• Strong understanding of CAR-T operations (e.g., T-cell handling, transduction, expansion, and cryopreservation) and vector production platforms.