cGMP Associate Director Process Development

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

• Manages and implements 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.
• develops and reviews standard operating procedures, protocols, process development reports, and technical reports
• Sets up labs for process development work (e.g., purchases and installs equipment, establishes lab SOP). Participates in vendor management and qualification visits as needed.
• Acts as the technical expert for process development, offering guidance and instruction on clinical manufacturing and cGMP design considerations.
• Assists cGMP facility management in determining necessary resources and support to effectively carry out projects.
• Offers training to manufacturing and quality control teams during the tech transfer process.
• Designs and produces viral vectors and characterizes them by performing varied in vitro and in vivo assays.
• Supports in-process testing, product characterization, final product release and comparability testing.
• Creates Chemistry, Manufacturing, and Control (CMC) documentation for Investigational New Drug (IND) applications. Develops validation plans for new products and ensures facility compliance with relevant regulations in collaboration with senior staff.
• Designs, carries out, summarizes, and presents process development studies while ensuring thorough documentation practices.
• Identifies problems and deficiencies through gap analyses and risk assessments.
• Offers suggestions for studies and solutions to improve the manufacturing process.
• Participates in regular meetings with the management team to provide updates on project progress, facility requirements and to address any other necessary items.
• 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.
• Performs 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 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.

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.

Salary : $130,000 - $139,000