Supports daily manufacturing operations in current Good Manufacturing Practice (cGMP) facilities. Maintains materials, gowning, cleaning supplies, and consumable supplies, manages manufacturing waste streams, cleans equipment, oversees documentation, and supports in other manufacturing duties as required.
The University of Southern California (USC), founded in 1880, is located in the heart of downtown L.A. and is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the âTrojan Family,â which is comprised of the faculty, students and staff that make the university what it is.
USCâs Keck School of Medicine, Department of Medicine is seeking a dynamic individual to work on manufacturing cell and gene therapies and other biological products for internal/external users in the universityâs current Good Manufacturing Practices (cGMP) facility. Core operator supports daily manufacturing operations in the cGMP facility, orders, receives and maintains materials, gowning, cleaning supplies, and consumable supplies, manages manufacturing waste streams, cleans equipment, oversees documentation, and supports in other manufacturing duties as required.
Performs all product manufacturing duties in cGMP facilities, adhering to all applicable gowning and safety requirements. Prepares and properly stores all incoming, intermediate and final products. Performs quality control for incoming, in-process and final products. Generates batch records, chain of custody forms, certificates of analysis and other records. Maintains complete documentation throughout the manufacturing process.
Orders cGMP facility equipment and supplies. Develops an inventory system for ongoing supplies and orders. Supports senior facility staff in maintaining cGMP budgets to ensure efficient use of equipment and materials. Establishes preventative maintenance schedule routines, and designs forms for maintaining documentation of equipment maintenance.
Acts as technical consultant to clinicians and researchers, providing technical assistance within the facility as necessary. Develops, implements and documents standard operating procedures, making updates as necessary. Instructs and oversees cGMP technicians and instructs graduate students and post-doctoral fellows in proper procedures within cGMP facilities. Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects.
Applies appropriate labels to incoming and outgoing products and monitors for proper labeling and handling during manufacturing. Ensures biohazard waste is handled appropriately and that medical waste stream rules and regulations are followed. Works with management to ensure facilities' compliance with all applicable regulations.
Plans and organizes workflows to meet established turnaround times, dispense dates and deadlines. Attends routine meetings with management team for progress reports on projects, facility needs, and discussion of any other required items. Recommends process improvements as appropriate.
Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold principles of the USC Code of Ethics.
Successful Candidates Must Demonstrate:
Degree in directly related specialized scientific field. Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
Fixed term: 3 years
The annual base salary range for this position is $100,000. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidates's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.
Minimum Education: Bachelor's degree OrBachelor's degree Pharmacy OrBachelor's degree Biology OrBachelor's degree in related field(s)Minimum Experience: 3 years in cellular or biological manufacturing with laboratory responsibilitiesMinimum Skills: Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs).Extensitve experience with standard operating procedures in a cGMP laboratory setting.Demonstrated ability to work as an individual contributor and in a dynamic team environment.Excellent written and oral communication skills.Preferred Education: Master's degree Biotechnology OrMaster's degree in related field(s)Preferred Skills: Demonstrated knowledge of all aspects of biotechnology and cell therapy.Demonstrated passion for solving complex scientific issues.Experience with Food and Drug Administration regulations and clinical trials.Extensive leadership experience.
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations.
As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.