Staff Associate I - GMP Cell Therapy Process Developer

American Society of Gene & Cell Therapy; New York, Northern (NY, KY); Hybrid; USD 75.000 - 95.000; Vollzeit

Zusammenfassung

Columbia University’s The Columbia Institute for Cell Engineering and Therapy (CICET) seeks a Staff Associate I to advance cell and gene therapy manufacturing. reporting to the Associate Director of PD and GMP manufacturing, you will collaborate with QC, Facility Management, QA, and research teams to scale production into a robust cGMP process, producing cell therapy drug products for Phase 1/2a trials.

You will apply GMP knowledge, design experiments, perform process development, document

Qualifikationen

• Bachelor's degree or higher in biology, biotechnology, cell biology, biochemistry, bioengineering, or related field with ~4 years' experience recommended.
• Hands-on CAR-T or viral vector process development and/or GMP cell manufacturing experience.
• Strong understanding of CAR-T operations and vector production platforms.

Aufgaben

• 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 - uses analytical skills to solve moderately complex problems, GMP training, and sound judgment and precedent.
• Decision Making/Autonomy - works within guidelines to design experiments, plan projects, conduct experiments, and analyze data.
• Technical Expertise - perform process development experiments and GMP manufacturing, maintain reagents and equipment for daily operations.
• Communication - document batch activities in real-time using GMP-compliant systems and controlled documents; contribute to project discussions and methodology.

Kenntnisse

CAR-T process development

Viral vector process development

GMP manufacturing

Data analysis

Ausbildung

Bachelor's degree in biology, Biotechnology, Cell Biology, Biochemistry, Bioengineering, or a related field

Tools

GMP documentation systems

Controlled documents management

Jobbeschreibung

Columbia University’s The Columbia Institute for Cell Engineering and Therapy (CICET) seeks a Staff Associate I to advance cell and gene therapy manufacturing. reporting to the Associate Director of PD and GMP manufacturing, you will collaborate with QC, Facility Management, QA, and research teams to scale production into a robust cGMP process, producing cell therapy drug products for Phase 1/2a trials.

You will apply GMP knowledge, design experiments, perform process development, document