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. The Keck School of Medicine at USC is seeking a highly motivated individual to join the USC/CHLA Cell Therapy program and cGMP Facility. The successful candidate will work on the process development and manufacture of cell and gene therapies, as well as other biological products, in compliance with current Good Manufacturing Practices (cGMP). As the Associate Director of Process Development, the individual will be responsible for creating protocols and methods for the production of various cell and gene therapy products, procuring the necessary equipment and components for cGMP production, making adjustments to the process and reagents to meet cGMP requirements, facilitating technology transfers, and developing assays for product characterization. The individual will also play a key role in establishing viral and non-viral vector platforms within the cGMP facility. Job Accountabilities: Manage and implement the development, optimization, and scaling of processes for the production of cell therapies and biologics in accordance with cGMP guidelines. Create and execute project plans for process and assay development and support the transfer of processes to cGMP manufacturing and quality control. Develop and review standard operating procedures, protocols, process development reports, and technical reports. Set up labs for process development work (e.g., purchases and installs equipment, establishes lab SOP). Participate in vendor management and qualification visits as needed. Act as the technical expert for process development, offering guidance and instruction on clinical manufacturing and cGMP design considerations. Assist cGMP facility management in determining necessary resources and support to effectively carry out projects. Offer training to manufacturing and quality control teams during the tech transfer process. Design and produce viral vectors and characterize them by performing varied in vitro and in vivo assays. Support in-process testing, product characterization, final product release, and comparability testing. Create Chemistry, Manufacturing, and Control (CMC) documentation for Investigational New Drug (IND) applications. Develop validation plans for new products and ensure facility compliance with relevant regulations in collaboration with senior staff. Design, carry out, summarize, and present process development studies while ensuring thorough documentation practices. Identify problems and deficiencies through gap analyses and risk assessments. Offer suggestions for studies and solutions to improve the manufacturing process. Participate in regular meetings with the management team to provide updates on project progress, facility requirements, and to address any other necessary items. Promote 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. Perform 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 a 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 $130k - 139k. 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 candidate'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:

Master's degree in Pharmaceutical Sciences or related field(s). Minimum Experience:

4 years of cellular or biological manufacturing experience (e.g., process development and analytical methods). Minimum Skills:

Master's degree in a scientific discipline (e.g., pharmaceutical, biologics). Proven experience in leadership/management roles. Demonstrated experience in academic administration and quality management. Solid knowledge base in Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs), cellular and gene therapies, translational research, and the business of science. Demonstrated ability to work as an individual contributor and in dynamic team environments. Excellent written and oral communication skills. Preferred Education:

Doctorate in Biotechnology or related field(s). Preferred Experience:

6 years. Preferred Skills:

Doctorate in biotechnology or other related life science disciplines. Experience and knowledge of standard operating procedures in cGMP laboratory settings. Ability to drive vendor selection and engagement, manage relationships, evaluate vendor data, document test plans, and develop deployment workbooks.

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