GMP Technician I, Genetic Medicine
Weill Cornell Medicine
New York, NY
Job posting number: #7152039
Posted: June 5, 2023
Application Deadline: Open Until Filled
Job Description
Position SummaryResponsible 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.
Job 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.
Education
Bachelor's Degree
Experience
Bachelor's degree in Science, preferably with biology, bioengineering, and biochemistry majors.
Prior related experience.
Knowledge, Skills and Abilities
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.
Licenses and Certifications
Working Conditions/Physical Demands
Should feel comfortable working in a cleanroom wearing an overall gown including facemask and goggles.