Materials Management Specialist

UCI School Of Medicine CGMP Facility Role

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.

The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory.

Your Role on the Team Reporting to the cGMP Quality Assurance Manager the primary objective for this person is to lead GMP warehouse functional areas, including receiving and shipping, inventory control, and materials management. This individual must have experience in warehouse operations, technical skills (space utilization, handling efficiency, managing metric control plan). This person would work closely with fellow functional and cross-functional members including quality assurance and/or manufacturing team performance goals in the areas of safety, quality, and performance. A background in nonclinical development for gene and/or cell therapies and a proven ability to advance novel therapeutic approaches into clinical development is highly desirable. Ability to work in an independent fashion with minimum daily supervision on the manufacturing of biological products is necessary.

What It Takes to be Successful Required: Assist with operations process and improvement projects. Ability to accurately follow procedures with minimum direction. Ability to work effectively in team situations, cross-functionally as well as independently. Excellent oral, written, communication, and interpersonal skills. Strong documentation skills and attention to detail necessary in a GMP environment. Required knowledge of computer word processing, data management, and spreadsheet software. Ability to work designated schedule. Ability to comply with applicable personnel protective equipment requirements. General understanding of pharmaceutical supply chain. Demonstrate technical skills in materials management with the flexibility to handle multiple tasks. Experienced working with contract service providers such as offsite warehouse and logistics. Process-oriented with strong analytical skills for risk identification and management. Excellent verbal and written communication skills and can confidently communicate with all levels of staff in this collaborative work environment. Self-motivated and comfortable in a fast-paced GMP environment with minimal direction and able to adjust workload based upon changing priorities. Proficient in MS word, Excel, PowerPoint, Outlook, and warehouse management software. Bachelor's degree in supply chain, business administration, engineering, or related science discipline. At least one year of relevant Materials Management, Supply Chain, Warehouse/distributions at a pharmaceutical or biotech company. Preferred: Science Lab Administration experience. Special Conditions: Ability to lift up to 50 pounds for approximately 20% of a typical working day. Ability to work seated for approximately 40% of a typical working day. Ability to work standing for approximately 60% of a typical working day. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 65% of a typical workday. Ability to safely work with hazardous or flammable materials; including, but not limited to, chemicals and electrical equipment. Must be able to work overtime and flexible shifts