The Columbia Initiative in Cell Engineering and Therapy (CICET) is seeking a highly motivated Staff Associate I. The Staff Associate I, reporting to the Assistant 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.

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 Assistant 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.

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.

Columbia University is an Equal Opportunity Employer / Disability / Veteran

Pay Transparency Disclosure

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.

About Columbia University

Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.

Connections working at Columbia University