Quality Control Manager/Manager Research Project B
Job location: Stellar-Chance Laboratories
Employment Type: Full-time
Posted data: 2019-11-14
University OverviewThe 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 TitleQuality Control Manager/Manager Research Project BJob Profile TitleManager Research Project BJob Description SummaryThe Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/Job Description
Responsible for both strategic planning and day to day management of complex and broad range of projects conducted with collaborators both internal and external to Penn. With mentoring from the Principal Investigator, the Research Project Manager will take leadership role in developing study protocols, writing grants, managing the detailed operations of projects, analyzing qualitative and quantitative data, cultivating close relationships with community partner organizations, and drafting/editing manuscripts for submission to peer-reviewed journal. He/she will help develop the team's research strategy and will have ample opportunities to lead projects and co-author papers. Will be required to ensure that studies/research are conducted safely and according to protocol, provide supervision to educators and teams conducting the study/interventions and collaborates with peers from other Universities and funding agencies. Will also be responsible for coordinating grant applications and interacts with funding administrators and the University Business Office. Provides significant contributions to presentations and manuscripts, including multiple drafts for review and dissemination. Plays a primary role in other dissemination activities related to project findings.
The cGMP Quality Control Lab Manager is responsible for testing product intermediate, final products and stability of viral vector to demonstrate that products meet quality and safety specifications. The QC Lab manager will be hands-on in the QC Lab to support all analytical needs and ensure cGMP compliance. In addition, this role will own and review quality records, processes and documents, including method development, method validation, CAPAs, Change Controls and SOPs.
Duties: Hands on manager of QC functions including perform quality tests, method validation, equipment, document and data systems. Create, review, and approve protocols, supporting analytical data, and reports associated with method validation, testing, and release of GMP starting materials, intermediate and final products; Demonstrate technical proficiency in analytical methodology and adherence to cGMP principles; Review and approve Certificate of Analysis; Certificate of Test, and stability studies. Prepare data summaries and study reports; Serve as QC lead on analytical projects teams and production teams; Collaborate with regulatory to support IND filing/amendments on CMC section if required; Evaluate resources, including CROs, requirements to support projects and assure projects remain within budget. Train direct QC reports on job related functions and technical methods; Establish and review training curricula for the QC department to develop a comprehensive QC laboratory training plan. (5%); Other duties as assigned.
Contigent upon funding
Master's Degree with 3-5 years of related experience or equivalent combination of education and experience is required
Office, library, computer room
Typically sitting at a desk or table; Occasional lifting 25 lb. or less; Typically standing or walking
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.