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About the Role
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.
Responsibilities
- Manufactures AAV and Adenovirus based gene therapy products in cleanrooms following GMP, including reagent and media preparation, cell culture, virus purification, and aseptic filling.
- Completes required processing documentation, including Product Data Records (PDRs), Nonconformance Reports, and Change Control, following GMP documentation SOPs.
- Performs Quality Control (QC) testings using molecular biology and biochemistry techniques.
- 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, staying abreast of scientific literature and new developments.
- Performs other related duties as assigned.
Requirements
- Bachelor's degree in Science, preferably with biology, bioengineering, and biochemistry majors.
- Prior related experience.
- Comfortable working in a cleanroom wearing an overall gown including facemask and goggles.
Skills
- Excellent communication skills (both verbal and written).
- Demonstrated organizational skills.
- Ability to pay close attention to detail.
- Ability to meet multiple deadlines.
- Ability to handle multiple priorities.
Location
- Upper East Side
Work Type
- Full-time
Experience Level
- Entry Level
Education Level
- Bachelor's Degree
Salary/Compensations
- $26.98 - $30.82
About the Company
- Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of “any person, any study.”
Equal Opportunity
- No person shall be denied employment on the basis of any legally protected status or be subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.
- 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.