*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices Position Summary
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.
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.
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.
Weill Cornell Medicine is a comprehensive academic medical center that's committed to excellence in patient care, scientific discovery, and the education of future physicians in New York City and around the world. Our doctors and scientists-faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization-are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.
Weill Cornell Medicine is a global healthcare leader known for the world-class patient care, cutting-edge research and top-ranked education. Every day, the employees of Weill Cornell Medicine improve lives across the city and around the globe. They help patients stay well, and our benefits and programs aim to help our employees and their families stay well by supporting their physical, financial, and professional health.