University of Southern California · 2 months ago
cGMP Associate Director, Process Development
Los Angeles, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$130K/yr - $140K/yr
4+ years expThe University of Southern California (USC) is a world-class research university located in downtown L.A. They are seeking an Associate Director of Process Development to oversee operations related to the cGMP laboratory, focusing on the manufacturing and process development of cell and gene therapies. The role involves developing strategies, ensuring compliance, and fostering cross-functional collaboration to meet project deliverables.
EducationHigher EducationUniversities
Responsibilities
Develops and implements strategies that proactively identify and mitigate risks. Establishes strategic goals and objectives for product manufacturing operations. Enhances and supports cross-functional interactions and activity prioritization. Regularly ensures compliance with all relevant regulatory requirements
Oversees the implementation of project plans (e.g., process and assay development and qualification), support tech transfer of processes to cGMP manufacturing and assays to QC. Develops and reviews SOPs, protocols and technical reports
Works closely with internal/external stakeholders to ensure project success and competition. Coaches and develops staff and coordinates departmental hiring/staffing plans. Identifies improvement opportunities to optimize workflows and eliminate inefficiencies. Establishes metrics and reports on the state of cGMP operations to senior management
Participates in vendor management and qualification visits as needed. Attends regular meetings with management discussing progress reports, facility needs and other required items
Ensures timely delivery of project goals and creates periodic progress reports summarizing status and potential risks. Assists with design and delivery of training courses. Stays current with new/emerging technologies and approaches, leveraging the latest industry knowledge to facilitate opportunities for innovation and continuous improvement
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. Creates staff development opportunities, reads and contributes to journals, and participates in professional organizations, meetings, conferences, seminars, and training courses
Lead process development and optimization efforts of cell therapy products, including the design and production of viral vectors. Support assay development and qualification for product testing
Lead technology transfer to cGMP manufacturing and quality control, ensuring efficient scaling and implementation. Develop and review SOPs, protocols and process development reports. Authoring CMC documentation
Oversee lab setup and work with cGMP facility management to allocate resources and infrastructure for efficient project execution
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time
Qualification
Required
Master's degree in a scientific discipline (e.g., pharmaceutical, biologics)
Four years of cellular or biological manufacturing experience (e.g., process development and analytical methods)
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
Doctorate Biotechnology
Doctorate in related field(s)
6 years of experience
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
Company
University of Southern California
University of Southern California is a private research university offering opportunities for interdisciplinary study and collaboration.
10001+ employees
H1B Sponsorship
University of Southern California has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (253)
2024 (239)
2023 (172)
2022 (207)
2021 (182)
2020 (195)
Funding
Current Stage
Late StageTotal Funding
$19.64MKey Investors
Patient-Centered Outcomes Research InstituteCalifornia Institute for Regenerative MedicineCDA Foundation
2025-02-04Grant· $10.8M
2025-01-30Grant· $5.93M
2024-07-30Grant
Leadership Team
David A Barnhart
Director, USC Space Engineering Research Center
H
Hossein Pourmand
Assistant Vice President, Research Initiatives, University Advancement
Recent News
2026-01-17
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