Director of GMP Facility

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

The GMP Facility in the School of Medicine is designed for the manufacturing of cell and gene therapies for early phase clinical trials. The facility consists of seven ISO classified cleanrooms and support spaces with supporting utilities and infrastructure for manufacturing purposes, a storage warehouse for raw and finished product, a freezer farm, and an adjacent Quality Control laboratory. GMP operations may include the collection, processing, storage, and release of cell therapy and related products, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The GMP Facility consists of 5 pillars: process development, manufacturing, quality control, quality assurance, and finance/administration. Additionally, the GMP Facility hosts two educational programs: the Facility Operations Training Program (GMP FOTP) aimed at B.S./M.S. level students interested in developing a career path in cell and gene therapy manufacturing, and the GMP Professional Training Program (GPTP) for science professionals interested in cell and gene therapy development.

Your Role on the Team

The Director of the GMP Facility independently manages and provides technical direction in conjunction with the medical director for the GMP Facility on UCI's main Irvine Campus. Together, they work with leadership and the Cell and Gene Therapy Oversight Committee to develop the long-term vision and goals for the facility. Additionally, the Director develops policies and procedures, as well as managing ongoing operations of the program and oversees an operational budget to achieve objectives. The Director has 3 main responsibilities: 1) Oversee operations and coordination of 5 pillars within the GMP Facility, including team management, creating and revising standard operating procedures, ensuring staff training appropriate for their roles, and maintaining a safe and compliant GMP environment. 2) Oversees business development activities, including marketing the capabilities of the facility, building relationships with sponsors, and creating scopes of work and negotiations for incoming projects. The Director is responsible for creating an annual budget and ensuring that the GMP Facility operates staff and equipment in accordance with that budget. This role may also contribute to grant submissions for the support of the facility. 3) Oversees all educational and training programs, including quality by design studios for incoming projects. This role must lead staff with accountability-based performance evaluations, setting clear roles and responsibilities, and resolves conflicts that arise fairly and with compassion. The Director must act with professionalism, efficiency, strategic thinking, creative problem-solving, appropriate communications, and strong time-management, prioritization, and project management skills to oversee the dynamic activities associated with an academic GMP facility.

What It Takes to be Successful

Required:

• Academic or research background and recognized expertise in selected area.
• Expert oral and written communication skills.
• Leadership experience in academic and / or government agencies.
• Demonstrated expertise in building collaborations between academia, industry and / or governmental agencies.
• Demonstrated expertise with program building within a leading academic institution and administrative, budgetary, human resources and financial principles and practices.
• Expert ability to work with dynamic and diverse group of faculty, staff and students.
• Managerial experience and proven success in managing a complex research or academic program(s).
• Strong negotiation skills and verbal and written communication skills; ability to influence / persuade all levels of staff.
• Skills in organization and customer service to effectively manage multiple important priorities.
• Organizational skills sufficient to prioritize duties in an ever-changing environment.
• Must possess technical vocabulary to meet facility needs.
• Ability to listen, collect information, and give instructions in an effort to support, clarify, or resolve problems.
• Tact and diplomacy skills to meet the needs of a highly interactive position.
• Ability to work well under pressure to meet commitments and to remain flexible with a variety of changing demands.
• Ability to manage several projects or tasks simultaneously and to exercise appropriate judgment when prioritizing projects of assignments.
• Ability to work as a member of a team and to assist colleagues as needed.
• Ability to function and work in a diverse work environment.
• Knowledge of federal and state legislation and regulatory requirements pertaining to the GMP laboratory.
• Advanced degree in related area and / or equivalent experience / training.
• At least 5 years of experience in research roles with progressively complex responsibilities.
• Previous managerial experience.
• Prior experience with GMP manufacturing, cell and gene therapies preferred.

Preferred:

• Terminal degree in a related field (PhD, MD, etc.) preferred but not required.

Special Conditions:

• Some travel to conferences and for business development activities will be required (~10%)