Job Description

The Senior Staff Associate I, reporting to the Assistant Director of PD and GMP manufacturing, will collaborate with 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
• Extensive knowledge in cell and gene therapy scale-up process development (PD), tech transfer, GMP manufacturing, documentation and compliance, and analysis of cell and gene therapy products.
Problem Solving
• Addresses a wide range of complex PD and GMP production issues by applying analytical skills, GMP training, experience, and sound judgment based on established precedents.
Decision Making/Autonomy
• Works independently and collaboratively with the Assistant Director of PD and GMP manufacturing to design, execute, and interpret experiments.
Technical Expertise
• Comprehensive understanding of PD and GMP processes, tools, software and instruments used in the development and manufacturing.
Communication
• Explains complex information; collaborates and builds consensus among the GMP team members and users. May present at conferences and seminars. Participates in the development of funding proposals, manuscripts, and regulatory documentation.

Minimum Qualifications
• Bachelor’s degree in Biology, Biotechnology, Cell Biology, Immunology, Biochemistry, Bioengineering, or a related field and 6 to 10 years of experience; Master’s degree, or equivalent combination of education and experience preferred.
• Work experience cannot substitute for a Bachelor's degree.

Preferred Qualifications
• 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, gene delivery, transduction, expansion, and cryopreservation) and vector production platforms.

Other Requirements
• Potential Bloodborne Pathogen Exposure.
• Successful completion of applicable compliance and systems training requirements.

Salary Range: $85,000.00 - $100,000.00

Applications accepted at: apply.interfolio.com/188618

Equal Employment Opportunity Statement
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.