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.

Job Description Summary

The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.

The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the “go-to” organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.

Continuation of all GTP positions is contingent upon funding.  

Job Description

Our Vector Core is a state-of-the-art facility which provides vector-related materials and services in support of basic and translational research worldwide, producing vectors in support of IND-enabling research, conduct GLP assays, oversee CMO's in vector production and is expanding to conduct state-of-the art process development.

Due to our program's growth, the Vector Core is looking to add Director, Quality Control (QC) Operations to lead high priority analytical compliance programs and oversee daily internal and external operations for QC testing. 

As the Director, QC Operations, you will partner closely with Manufacturing, Process Development, and Analytical Development to support research programs to ensure we meet project timelines. You will assemble, review, and trend stability data, generating reports as necessary to support regulatory filings. Analytical method support will include but will not be limited to continuous monitoring of method performance (e.g., control charting, invalid rates, etc.), investigation management, data integrity reviews, and authoring and/or review of relevant regulatory documents, Standard Operating Procedures, and Protocols (i.e., method development, implementation and validation, specifications, batch analysis, reference standard, and stability). You will work with Vector leadership to implement IT solutions for compliance purposes and emerge as the Subject Matter Expert for QC/Analytical. You will need a team of scientists with diverse responsibilities to support QC operations. 

Qualified candidates will have a strong background in biologics analytics and quality control testing and experience working under GLP or GMP standards.

Qualifications:

• BS, MS, or PhD in a Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences or other relevant scientific field of study with at least 7+ years of Quality Control experience in a regulated Pharmaceutical or Biotechnology industry; Must have GLP or GMP experience.
• Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
• Proven leadership, organizational and management skills to coordinate cross functional decision making with executive leadership.
• Understanding and familiarity with FDA, European and international regulatory requirements, guidelines, and recommendations for quality system implementation .
• Understanding and experience with oversight of the pharmaceutical quality system including good manufacturing, laboratory, clinical and distribution practices.
• Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
• Experience writing regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections
• Experience validating methods and monitoring commercial method performance.
• Experience in authoring method, specification, reference standard, and stability sections of regulatory submissions
• Experience drafting protocols and technical reports and QC policies and procedures required.
• Experience with statistical analysis of analytical data and stability studies preferred.
• Cross-functional, hands-on experience at a small biotech/biopharma company.

Job Location - City, State

Philadelphia, Pennsylvania  

Department / School

Perelman School of Medicine  

Pay Range

$72,837.00 - $138,391.00  

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.