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.Â
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. The Manufacturing Specialist is responsible for establishing workflows, SOPs, and practices for manufacturing operations and develops methods for improving manufacturing processes. Establishes and manages the productions schedule and daily tasks as well as calibration and maintenance plans. Ensures that all production activities are performed according to cGMP requirements.
Creates technical reports and specifications, maintaining appropriate records. Drafts, writes, and edits scientific reports, papers, journal articles, and abstracts. Assists in preparing grant applications.
Establishes production processes, modifying raw materials, components, and process parameters as necessary to ensure quality. Devises, validates and/or refines processes to optimize the manufacturing process. Improves yields and reduces costs by investigating alternative machinery and materials and addressing quality and efficiency issues in bottleneck areas. Advises on equipment modifications to optimize new product development.
Implements appropriate and effective regulatory strategies. Participates in all relevant internal/external audits and inspections, maintaining set quality standards and ensuring the program meets GMP requirements.
Reviews Chemistry, Manufacturing, and Controls (CMC) information and any relevant clinical/non-clinical documentation. Assists in completing and coordinating successful submissions of Investigational New Drug (IND) applications. Develops formulas, assays, and specifications to ensure compliance with finished product release criteria.
Stays current with developments in the field and presents information on research and program work at appropriate meetings, journal clubs, and seminars. Helps develop new courses at the undergraduate and graduate level.
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.
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.
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 $103,000. 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: Bachelorâs DegreeMinimum Experience: 3 Years Preferred Education: Masterâs DegreePreferred Experience: 5 YearsSupervises: Supervises â Nature of WorkPreferred Field of Expertise: Biotechnology and life sciences
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.