GMP Technician I

Weill Cornell Medicine; New York (NY); Sur place; USD 37 000 - 42 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication skills

Organizational skills

Attention to detail

Deadline management

Formation

Bachelor's Degree

Description du poste

Title

GMP Technician I

Location

Upper East Side

Org Unit

Belfer Gene Therapy Core

Work Days

Monday-Friday

Weekly Hours

35.00

Exemption Status

Non-Exempt

Salary Range

$26.98 - $30.82

• 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.

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.

Working Conditions/Physical Demands

Should feel comfortable working in a cleanroom wearing an overall gown including facemask and goggles.

Cornell University Diversity and Inclusion Statement

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." No person shall be denied employment on the basis of any legally protected status or 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.