GMP Gene Therapy Technician I

Weill Cornell Medicine; New York (NY); On-site; USD 37,000 - 42,000; Full time

Job summary

Weill Cornell Medicine on the Upper East Side seeks a GMP Technician I to manufacture and QC gene therapy products in compliance with the Belfer Gene Therapy Core facility standards and FDA/EU Good Manufacturing Practice guidelines for early drug development.

Responsibilities include GMP production in cleanrooms, reagents preparation, cell culture and virus purification, completing documentation, drafting SOPs, participating in equipment qualification and process validation, and maintaining

Qualifications

• 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 culture 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.

Skills

Communication skills

Organizational skills

Attention to detail

Deadline management

Education

Bachelor's Degree

Job description

Weill Cornell Medicine on the Upper East Side seeks a GMP Technician I to manufacture and QC gene therapy products in compliance with the Belfer Gene Therapy Core facility standards and FDA/EU Good Manufacturing Practice guidelines for early drug development.

Responsibilities include GMP production in cleanrooms, reagents preparation, cell culture and virus purification, completing documentation, drafting SOPs, participating in equipment qualification and process validation, and maintaining