GMP Technician I

Weill Cornell Medicine; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Weill Cornell Medicine in New York, NY is seeking a GMP-focused professional to manufacture and QC gene therapy products in the Belfer Gene Therapy Core Facility, following FDA/EU GMP standards for early drug development. Bachelor’s degree required.

The role involves hands-on manufacturing of AAV and adenovirus products in cleanrooms, document control, QC testing, SOP updates, equipment qualification, and collaboration with GMP teams to advance process development and transfer.

Qualifications

• Bachelor's degree in Science (biology, bioengineering or biochemistry preferred).
• Prior related experience.
• Excellent communication skills.

Responsibilities

• Manufactures AAV and Adenovirus gene therapy products in GMP cleanrooms.
• Completes processing documentation (PDRs, NCRs, Change Control, CAPA) per SOPs.
• Performs QC testing using molecular biology and biochemistry methods.
• Drafts and revises SOPs and Production Data records.
• Participates in equipment qualification and process validation.
• Supports GMP process development and transfer; maintains detailed records.
• Maintains production room sanitation and attends GMP meetings.
• Keeps up with literature and new product developments.

Skills

Excellent communication

Organizational skills

Attention to detail

Time management

Education

Bachelor's Degree in Science

Job description

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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.

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.


• 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.

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Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans' Readjustment Assistance Act (VEVRRA). We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.