The University of Pennsylvania Abramson Cancer Center and Novartis Pharmaceuticals has formed an alliance to expand the use of personalized T Cell therapy for Cancer patients. The alliance is aimed at bringing a new, personalized immunotherapy approach to patients with a wide variety of cancers. The alliance is an exclusive global research and licensing agreement to further study and commercialize novel cellular immunotherapies using chimeric antigen receptor (CAR) technologies. The agreement, which follows a Penn research team's 2011 publication of breakthrough results in several chronic lymphocytic leukemia patients treated with this personalized immunotherapy technique, paves the way for pivotal studies that have the potential to expand the use of CAR therapies for additional cancers.
The Abramson Cancer Center is currently seeking experienced professionals for the following role within the Translational Research Center:
Quality Systems Manager
Reference Number: 121133769
The candidate will lead efforts to assure compliance with applicable regulations and industry accepted standards that govern good manufacturing practices (GMP) and Good Laboratory Practices (GLP) of cell and gene therapies in the Clinical Cell and Vaccine Production Facility. The candidate will plan, coordinate, and direct a quality systems program designed to ensure continuous production of cells products consistent with established standards, develop and analyze product specifications for release, and establish proposed quality and reliability parameters of the final product. Responsibilities include quality systems operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality standards; identifying and resolving problems; responding to and acting on findings from both internal and external audits; determining system improvements and implementing change. The candidate will formulate and maintain quality control objectives and coordinates objectives with production procedures in cooperation with GMP technical staff. The candidate will develop quality systems plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures, and monitoring inventories. Mentor and supervise junior quality management personnel. The candidate will plan, promote, and organize training activities related to product quality and reliability. Responsibilities include managing quality audits, CAPA, Root Cause Analysis, quality control release testing, writing Standard Operating Procedures (SOP's) and managing quality systems documentation.
The minimum of a Bachelor's
degree and 5 years to 7 years of experience or equivalent combination of
education and experience is required.
Masters of Science in Biology or related field, strongly preferred. Previous training in regulatory affairs and clinical research required with preference given to candidates with academic Investigator-initiated clinical trials experience. Previous experience in dangerous good handling and shipping preferred.
Experience with quality systems required, including any of the following: previous experience in managing quality audits, CAPA, Root Cause Analysis; quality control release testing, managing quality systems documentation including writing/revising SOP's. Position contingent upon funding.
A background check is required for this position.
For more information about working at Penn and to apply for this position, please submit a cover letter and resume online at the University of Pennsylvania’s Human Resource website:
Alternatively you may search by reference number 121133769 at http://jobs.hr.upenn.edu//
The University of Pennsylvania is an equal opportunity, affirmative action employer. Women and minority candidates are strongly encouraged to apply.