cGMP Associate Director, Process Development

University of Southern California•Los Angeles, CA

4d•$130,000 - $140,000

About The Position

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 is comprised of 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/external users. The Associate Director of Process Development (cGMP) is responsible for all aspects of operations related to the current Good Manufacturing Practices (cGMP) laboratory, including manufacturing and process development activities, in order to ensure that project deliverables meet schedule, cost, scope, quality, and safety and ensuring continuous improvement by engaging all employees.

Requirements

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.

Nice To Haves

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.

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.