cGMP Associate Director, Process Development

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 Trojan Family, which comprises the faculty, students, and staff that make the university what it is. Usc’s Keck School of Medicine, cGMP Department is seeking a dynamic individual to foster and enhance the translation and manufacturing of cell and gene therapies and other biological products for internal and external users. The Associate Director of Process Development (cGMP) will manage all aspects of cGMP laboratory operations, ensuring project deliverables meet schedule, cost, scope, quality, and safety. Job Accountabilities Develop and implement strategies that proactively identify and mitigate risks, establish strategic goals and objectives for product manufacturing operations, and enhance cross‑functional interactions and activity prioritization. Oversee implementation of project plans (e.g., process and assay development and qualification), support tech transfer of processes to cGMP manufacturing, develop and review SOPs, protocols, and technical reports. Work closely with internal and external stakeholders to ensure project success; coach and develop staff and coordinate departmental hiring and staffing plans. Identify improvement opportunities to optimize workflows and eliminate inefficiencies; establish metrics and report on the state of cGMP operations to senior management. Participate in vendor management and qualification visits; attend regular meetings with management to discuss progress, facility needs, and other required items. Ensure timely delivery of project goals; create periodic progress reports summarizing status and potential risks; assist with design and delivery of training courses. Stay current with new and emerging technologies and approaches, leveraging industry knowledge to facilitate opportunities for innovation and continuous improvement. Promote an inclusive environment, foster unbiased opportunities for contributions, and support professional development through journals, conferences, and training courses. Lead process development and optimization efforts of cell therapy products, including design and production of viral vectors and assay development for product testing. Lead technology transfer to cGMP manufacturing and quality control, ensuring efficient scaling and implementation of SOPs and protocols. Oversee laboratory setup and work with cGMP facility management to allocate resources and infrastructure for efficient project execution. Perform other related duties as assigned or requested. The university reserves the right to add or change duties at any time. Qualifications Required: Master’s degree in a scientific discipline (e.g., pharmaceutical sciences, biologics). Four years of cellular or biological manufacturing experience, including process development and analytical methods. Proven experience in leadership or management roles. Demonstrated experience in academic administration and quality management. Solid knowledge of Good Manufacturing Practices (cGMPs, GLPs, GDPs), cellular and gene therapies, translational research, and the business of science. Ability to work as both an individual contributor and as part of a dynamic team. Excellent written and oral communication skills. Preferred: Doctorate in biotechnology or related life science discipline. Experience and knowledge of standard operating procedures in cGMP laboratory settings. Experience in vendor selection and engagement, evaluating vendor data, documenting test plans, and developing deployment workbooks. This is a 3‑year fixed‑term position. Salary: The annual base salary range for this position is $130,000 – $140,000. Factors considered include scope, responsibilities, experience, education, and market data. Equal Opportunity Employer: USC is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law. USC observes affirmative action obligations consistent with state and federal law. USC will consider applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance. Reasonable Accommodations: USC provides reasonable accommodations to applicants and employees with disabilities. Applicants can contact USC Human Resources at View phone number on click.appcast.io or via email at View email address on click.appcast.io for accommodation requests. Notice of Non‑discrimination Employment Equity Read USC’s Clery Act Annual Security Report USC is a smoke‑free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting the following link into your browser: #J-18808-Ljbffr Dormont Manufacturing Co