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cGMP Process Development (PD) Specialist

Join to apply for the cGMP Process Development (PD) Specialist role at USC Rossier Global Executive Ed.D.

Apply Keck School of Medicine Los Angeles, California

The University of Southern California (USC), founded in 1880, is located in downtown LA and is the largest private employer in the city. As an employee, you will be part of a world-class research university and the "Trojan Family."

USC’s Keck School of Medicine is seeking a dynamic individual for process development and manufacturing of cell and gene therapies and other biological products. The Process Development (PD) Specialist will develop procedures for production, identify necessary equipment, implement process changes for cGMP compliance, support technology transfer, and develop assays for product characterization. The role also involves establishing viral and non-viral vector platforms under cGMP conditions.

Job Responsibilities

• Lead process development, optimization, and scale-up activities for cell therapies and biologics, including project planning and SOP review.
• Set up labs, purchase and install equipment, and establish lab SOPs.
• Provide technical direction, training, and support during tech transfer, ensuring cGMP compliance.
• Design and produce viral vectors, perform assays, support testing and product release, and prepare documentation for IND applications.
• Conduct process development studies, perform gap analyses, and recommend solutions.
• Promote an inclusive environment and uphold USC's ethical principles.
• Perform other duties as assigned, with the understanding that responsibilities may evolve.

Qualifications

Degree in a related scientific field, with at least 3 years of experience in cellular or biological manufacturing, process development, and analytical methods. Experience with scale processes, cell culture platforms, and cGMP regulations is required. Excellent communication skills are essential. A PhD is preferred, with 5+ years of experience being advantageous.

Compensation

Annual salary range : $93,900.53 - $100,000. The position is fixed-term for 3 years. USC considers various factors in salary offers, including experience and internal equity.

Additional Details

Other Information

Position posted on 03 / 09 / 2025. Employment type : Full-time, Mid-Senior level, in Management and Manufacturing within Higher Education.

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