Rutgers, The State University of New Jersey is seeking a Director, GMP Facility for the Cancer Immunology and Metabolism Department within the Rutgers Cancer Institute of New Jersey.
Reporting to the Co-Director of the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence, this position is responsible for oversight of the GMP facility and working with collaborating laboratories to transfer, develop, and implement methodologies for the production of cell and gene products for human administration. This position will lead GMP operations, including oversight of standard operational procedures (SOPs), budget development, project management, resource and personnel management, performance of experimental work, development and implementation of experimental protocols, workflow, financial management, and training and supervision of staff.
Among the key duties of this position are the following:
Directs the operations of the GMP facility.
Manufactures cell and gene products for human administration.
Maintains regulatory compliance.
Contributes to trial development strategy and assists with protocol development.
Works with Quality Assurance (QA) group to ensure quality control procedures are established as required by FDA and the cGMP production of translational blood and cellular therapy products.
Plans, conducts, and interprets scientific research experiments for research/development of translational blood and cellular therapy product manufacturing; supervise process development.
Minimum Education and Experience:
Ph.D. in Biomedical Science, Biology, Chemistry, Engineering or related field.
Ten (10) years in scientific research with five (5) years of experience in management in cellular therapies labs, including cGMP facilities, cord blood, in vitro cell culture, related analytical labs, experimental, and clinical trials studies.
Required Knowledge, Skills, and Abilities:
Knowledge of cGMP, GCP, FDA, FACT, and AABB.
Knowledge of laboratory and regulatory requirements in cellular therapy related research.
Working knowledge of IRB and regulatory approvals and developing FDAIND submissions.
Working knowledge of Materials and Technology Transfer including transitioning of research techniques into cGMP production methods and start-up of existing or new processes at internal and external manufacturing facilities.
Knowledge of Microsoft Suite (Word, Excel, PowerPoint, Visio) and general analytics.
Demonstrated ability to work in a fast-paced environment supervising multiple projects and activities simultaneously.
Possesses personal leadership qualities that inspire trust, respect, credibility, and confidence of peers and colleagues and takes the organization to a higher level.
Knowledge of stem cell/cellular therapy/adoptive immunotherapy literature, experience in science-based cGMP manufacturing, demonstrated innovative thinking.
Well-developed interpersonal skills; experienced communicator, ability to provide clear and logical presentation of complex strategic issues.
Demonstrated ability to manage people and to assign work effectively based on staff skills.
Proven ability to design and implement studies with direct translation.
Resilient, energetic, and enthusiastic, responding constructively to challenging new ideas and inputs.
Strategic thinking, innovating with informed, sharp, and objective practical purpose. Experienced in detailed analysis, interpretation, and reporting.
Strong interpersonal skills and networking.
Ability to develop productive relationships with academic scientists and research/business executives in the biotechnology, pharmaceutical, and medical device industries.
Experience in participating and leading cross-functional/matrix project teams.
Proven ability to maintain effective oversight of a project and schedule progress to predetermined milestones, experience in developing and monitoring detailed budgets.
Demonstrated ability to handle pressure and ambiguity; comfortable with the pressure to excel and ability to maintain focus in situations of ambiguity and uncertainty.
Effective oral and communication skills.
Computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Posting Number: 20ST1723
Location: Downtown New Brunswick
Internal Number: 120091
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.