Senior Quality Control Technologist

Job description



Senior Quality Control Technologist

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title
Senior Quality Control Technologist

Job Profile Title
Quality Control Technologist Senior

Job Description Summary
This position will support Quality Control clinical testing activities for cell and gene therapy clinical trials to treat patients with cancer and HIV supported by the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania. This position reports to the Quality Control Team lead with primary responsibilities that include demonstrating proficiency to perform clinical release testing on cell therapy products, including but not limited to, immunophenotyping (Flow Cytometry), sterility, mycoplasma, viability, residual bead counting, and ex vivo culture assays. Use of sterile technique and universal precautions as well as capabilities to perform immunoassays with primary human cells from study subjects in support of cell and gene therapy clinical trials at the University of Pennsylvania and collaborating institutions, is required. Proven subject matter expertise and ability to lead validation projects to improve and/or optimize current processes is required. Additional responsibilities include equipment, reagent and supply validation for new and improved testing methods. Additional responsibilities may apply. Routine interaction with manufacturing technicians, quality control scientists, quality assurance personnel, and additional support staff is necessary. This position is an Essential University employee and is required to report to work in times of inclement weather and University closure.

Job Description

This position will support Quality Control clinical testing activities for cell and gene therapy clinical trials to treat patients with cancer and HIV supported by the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania. This position reports to the Quality Control Team lead with primary responsibilities that include demonstrating proficiency to perform clinical release testing on cell therapy products, including but not limited to, immunophenotyping (Flow Cytometry), sterility, mycoplasma, viability, residual bead counting, and ex vivo culture assays. Use of sterile technique and universal precautions as well as capabilities to perform immunoassays with primary human cells from study subjects in support of cell and gene therapy clinical trials at the University of Pennsylvania and collaborating institutions, is required. Proven subject matter expertise and ability to lead validation projects to improve and/or optimize current processes is required. Additional responsibilities include equipment, reagent and supply validation for new and improved testing methods. Additional responsibilities may apply. Routine interaction with manufacturing technicians, quality control scientists, quality assurance personnel, and additional support staff is necessary. This position is an Essential University employee and is required to report to work in times of inclement weather and University closure.

Qualifications: Bachelor's degree in Biology or related science required, Master's degree strongly preferred. 3 to 5 years or equivalent combination of experience and education in cell culture or immunology is required. Experience with tissue culture and stringent aseptic technique is required. Previous experience with human primary cell cultures is required. Direct experience culturing T cells and/or dendritic cells is strongly preferred. Working knowledge of HIPAA requirements, and experience with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Laboratory (Research) Practices (GCP) is desired. Experience with testing samples from large scale expansion cultures manufactured in a regulated clean room laboratory environment, according to good laboratory practices (GLP) and good tissue practices (GTP) is strongly desired. Demonstrated proficiency to perform assays in at least one specialized Quality Control functional area (ie. Flow Cytometry, microbiology, viability, ex vivo cell culture) is required. Ability to be cross-trained to perform QC assays across specialized functions is desired. Excellent verbal and written communication skills are required. Previous demonstrated experience working with clinical trials, and in particular, and clinical product release testing is preferred. Knowledge of medical terminology and intellectual capacity to use judgement and critical thinking skills to ensure that the data are accurate, logical, and consistent with institutional and regulatory reporting requirements are required. Efficient time management and ability to multi-task at a given time are essential. Excellent organizational record keeping skills are necessary. Flexibility to work weekends is required. Position is contingent upon funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$59,614.00 - $89,421.00

Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/Senior-Quality-Control-Technologist_JR00025419-1





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Job No:
Posted: 10/8/2020
Application Due: 12/7/2020
Work Type:
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