GMP Technician I

Responsible for manufacturing and performing quality control tests of gene therapy products in compliance with the Belfer Gene Therapy Core quality system and FDA or EU Good Manufacturing Practice Standards for early drug development. This role supports GMP production of AAV and Adenovirus vectors in cleanrooms. Focuses on precise execution to meet regulatory requirements.

Daily tasks include reagents and media preparation, cell culture, virus purification via filtration, gradient, or chromatography methods, and aseptic filling. Completes processing documentation such as Product Data Records, Nonconformance Reports, Change Control, and CAPA per Standard Operating Procedures. Performs QC testing using molecular biology and biochemistry techniques.

Works in the Belfer Gene Therapy Core Facility on the Upper East Side, participating in production room sanitization and environmental monitoring. Attends GMP meetings, training programs, and institutional sessions. Collaborates in a cleanroom environment requiring gowning with facemask and goggles.

Opportunities include drafting and revising SOPs and Production Data Records, equipment qualification, process validation, and GMP process development or transfer. Maintains detailed records, logs, and summary reports. Conducts library research and stays current with scientific literature on laboratory developments.