Rutgers, the State University of New Jersey is seeking a GMP & Cellular Therapy Program Manager for the Clinical Research Enterprise department at Rutgers Cancer Institute of New Jersey (CINJ).
The Program Manager, GMP and Cellular Therapy (QA/QC) is responsible for ensuring the quality and safety of TCR engineered T cell therapy and other products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. This role is responsible for overseeing and approving the design, implementation, and management of the quality management system for the Cell Therapy Program. The Program Manager, GMP and Cellular Therapy (QA/QC) will lead QMS related projects and serve as an expert resource, providing quality oversight and ensuring regulatory and accreditation compliance for cellular therapy products manufacturing and distribution, clinical services, laboratory services, clinical research, and general support functions such as information systems, facilities and safety related to the Cell Therapy Program.
Among the key duties of this position are the following:
Provides quality oversight and GMP guidance to manufacturing, QC, engineering/facilities. Responsible for developing and maintaining processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP.
Develops and maintains phase-appropriate quality systems for both clinical and commercial manufacturing environments, including document management, deviations, CAPA, change control, training, and auditing.
Approves the design and oversees the implementation of CINJ's cell therapy quality management system, including development, improvement, and review of related SOPs, processes, IT solutions, and quality tools.
Provides QA oversight and leadership to ensure timely disposition and delivery of GMP compliant manufacturing drug products that are fit for purpose.
Protects the safety of patients and HCT/P donors by advising subordinates, as needed and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services.
Minimum Education and Experience:
Bachelor’s degree in life sciences, pharmaceutical, biotech, or biologics manufacturing, or quality management.
Equivalent experience, education and/or training may be substituted for the education requirements.
Minimum five (5) years required (seven (7) years preferred) of specialized experience, including performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting.
Ten (10) years total relevant experience, includes any combination of: 1) specialized experience described above 2) clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting
Minimum two (2) years management experience required, (five (5) years management experience preferred) including supervision, project management, and/or program management.
Required Knowledge, Skills, and Abilities:
Strong working knowledge of quality system and regulatory requirements (21 CRF Part 11/210/211, 21 CFR 1271, ICH 8, ICH 9, ICH 10) in both U.S. and E.U. ID.
Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies.
Expert knowledge of regulations and accreditation standards applicable to cGMP facility and cell therapy program.
Expert ability to apply knowledge of, and interpret applicable federal, state, local, and international regulations and standards, technical specifications, and other guidelines to evaluate compliance.
Expert ability to analyze and interpret observational, operational, and quality data to monitor process performance and to determine if products and services are performing within defined specifications.
Expert ability to conduct studies and investigations, problem analysis, and risk assessments to develop logical and well-documented recommendations.
Highly proficient at preparing and delivering clear, concise, and effective written and oral communications.
Highly proficient at establishing effective interpersonal relationships to meet the goals of the organization.
Computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Familiarity with FACT (Foundation for the Accreditation of Cellular Therapy) Accreditation Standards.
Posting Number: 21ST0295
Location: Downtown New Brunswick
Internal Number: 126403
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.