GMP Technician I

Weill Cornell Medical College•New York, NY

3d•Onsite

About The Position

Responsible for manufacturing and performing quality control (QC) tests of gene therapy products in compliance with the quality system established in the Belfer Gene Therapy Core Facility and the FDA and/or EU Good Manufacturing Practice Standards for early drug development phase.

Requirements

Bachelor's degree in Science, preferably with biology, bioengineering, and biochemistry majors.
Prior related experience.
Excellent communication skills (both verbal and written).
Demonstrated organizational skills and ability to pay close attention to detail.
Ability to meet multiple deadlines and handle multiple priorities.

Responsibilities

Manufactures AAV and Adenovirus based gene therapy products in cleanrooms following GMP. Procedures include reagents and media preparation, cell cuture and virus purification using filtration, gradient and/or chromatography methods, and aseptic filling.
Completes required processing documentation, including Product Data Records (PDRs), Nonconformance Reports, Change Control, CAPA etc. following the Standard Operating Procedures (SOPs) for GMP documentation.
Performs Quality Control (QC) testings using techniques of molecular biology and biochemistry.
Drafts and revises Standard Operating Procedures (SOPs) and Production Data records (PDRs).
Participates in equipment qualification (EQ) and process validation.
Participates in GMP process development and process transfer activities.
Prepares and maintains detailed records, logs and summary reports of all procedures and results.
Performs environment monitoring.
Participates in production room sanitization.
Attends GMP meetings and training programs and other institutional meetings and training programs.
Conducts library research and literature searches.
Keeps abreast of scientific literature and new developments in laboratory products.
Performs other related duties as assigned.