cGMP MSAT Manager

University of California, Irvine•Irvine, CA

17h•Onsite

About The Position

The MSAT Manager will have a broad range of responsibilities that maintain the viability of these new facilities for the development, scale up, and production of cellular therapeutics. This program will serve the University of California at Irvine community and extramural organizations. The MSAT Manager will have direct oversight of all aspects of process development for novel gene and cell therapy products. The MSAT Manager will report administratively to the GMP Facility Director. Oversight and direction will also be provided by the Medical Director, other leadership, and the Cell and Gene Therapy Oversight Committee. This reporting structure is consistent with the expectation that the GMP and the cell processing laboratories will cooperate to support investigators across the entire biomedical spectrum residing within multiple UCI academic units, will of necessity interface with UCI Health, and will have significant extramural contracted use. They 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.

Requirements

Adherence to excellent customer service principles.
Organizational skills sufficient to prioritize duties in an ever-changing environment.
Must possess technical vocabulary to meet facility needs.
Must possess knowledge of medical terminology, basic human anatomy, chemistry, biology and molecular biology and technical knowledge to complete assigned tasks.
Ability to listen, collect information, and give instructions in an effort to support, clarify, or resolve problems.
Knowledge of personal computer, word processing, data management, and spreadsheet software.
Knowledge of standard precautions and biosafety.
Knowledge of Occupational Safety and Health Act (OSHA) and laboratory safety regulations.
Outstanding written and oral communication skills. Ability to lead discussions, to particulate test procedures, and to make effective presentations. Utilize effective listening and questioning techniques.
Must be able to write clear technical reports in the scientific format. Must be able to maintain logs and documentation in the same manner.
Maintains appropriate interdepartmental communication.
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.
In depth knowledge of GMP laboratory policies and procedures as documented in SOPs
Teaching and communication skills necessary for interactions with students, and postdoctoral fellows.
Bachelor's degree in related area and / or equivalent experience / training
At least 5 years of experience in research roles with progressively complex responsibilities
Previous experience in a managerial function
Must be able to provide proof of work authorization

Nice To Haves

Some graduate level coursework preferred.
Experience working in a GMP facility, focusing on process development and manufacturing of cellular therapy products
Previous experience managing in vivo studies to support the development of novel cell therapies, including assisting with experiment design
Experience in or knowledge of GMP production procedures and facilities is preferred. Alternatively, the candidate must be willing to be trained for a period of at least 3-6 months in a GMP facility with extensive experience in cell manufacturing.

Responsibilities

Direct oversight of all aspects of process development for novel gene and cell therapy products.
Maintain the viability of new facilities for the development, scale up, and production of cellular therapeutics.
Act with professionalism, efficiency, strategic thinking, creative problem-solving, appropriate communications, and strong time-management, prioritization, and project management skills.