cGMP Associate Director, Process Development

University of Southern California; Los Angeles (CA); On-site; USD 130,000 - 140,000; Full time

Job summary

University of Southern California seeks an Associate Director of Process Development (cGMP) to lead manufacturing operations and process development for cell and gene therapies. You will drive strategy, oversee tech transfer to cGMP facilities, and ensure project milestones are met with quality and compliance.

Preferred candidates hold a Master’s degree in a scientific field and have 4+ years in cellular/biological manufacturing, including leadership and QA experience.

Qualifications

• 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.

Responsibilities

• Develops and implements strategies that proactively identify and mitigate risks.
• Establishes strategic goals and objectives for product manufacturing operations.
• Oversees tech transfer to cGMP manufacturing and quality control.
• Leads process development and optimization for cell therapy products, including viral vectors.
• Authoring CMC documentation and SOPs / technical reports.

Skills

Leadership

Communication

Education

Master's degree in pharmaceutical sciences

Doctorate in biotechnology

Job description

About the University

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.

Position Overview

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.

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.

Qualifications

• 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.

Term and Salary

This is a 3 year fixed-term position.

Salary: The annual base salary range for this position is $130,000 - $140,000.

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.

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.

Minimum Education: Master's degree Pharmaceutical Sciences Or Master's degree in 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 Biotechnology Or Doctorate in 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.

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 or USC policy. USC observes affirmative action obligations consistent with state and federal law.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at [phone], or by email at [e-mail]. Inquiries will be treated as confidential to the extent permitted by law.

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USC is a leading private research university located in the heart of downtown Los Angeles – a global center for arts, technology and international business. As the largest private employer in the city – responsible for more than $5 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.

As a USC employee, you will enjoy excellent benefits and perks, and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work.