cGMP Vector Manufacturing Specialist

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, Department of Medicine is seeking a dynamic individual to work on manufacturing cell and gene therapies and other biological products for internal/external users in the university’s current Good Manufacturing Practices (cGMP) facility. The Vector Manufacturing Specialist is responsible for establishing workflows, SOPs, and practices for manufacturing operations and develops methods for improving manufacturing processes. Establishes and manages the productions schedule and daily tasks as well as calibration and maintenance plans. Ensures that all production activities are performed according to cGMP requirements.

Job Accountabilities

• Creates technical reports and specifications, maintaining appropriate records. Drafts, writes, and edits scientific reports, papers, journal articles, and abstracts. Assists in preparing grant applications.
• Establishes production processes, modifying raw materials, components, and process parameters as necessary to ensure quality. Devises, validates and/or refines processes to optimize the manufacturing process. Improves yields and reduces costs by investigating alternative machinery and materials and addressing quality and efficiency issues in bottleneck areas. Advises on equipment modifications to optimize new product development.
• Implements appropriate and effective regulatory strategies. Participates in all relevant internal/external audits and inspections, maintaining set quality standards and ensuring the program meets GMP requirements.
• Reviews Chemistry, Manufacturing, and Controls (CMC) information and any relevant clinical/non-clinical documentation. Assists in completing and coordinating successful submissions of Investigational New Drug (IND) applications. Develops formulas, assays, and specifications to ensure compliance with finished product release criteria.
• Stays current with developments in the field and presents information on research and program work at appropriate meetings, journal clubs, and seminars. Helps develop new courses at the undergraduate and graduate level.
• 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 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.

The annual rate range this position is $92,070 - $103,950. 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' 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: Bachelor's degree Bachelor's degree Pharmacy Or Bachelor's degree Biology Or Bachelor's degree in related field(s)
Minimum Experience: 3 years in cellular or biological manufacturing and with process development and analytical methods
Minimum Skills: Familiarity with manufacturing methods and procedures. Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs). Experience applying sound technical judgement to a variety of manufacturing scenarios. Excellent planning and time management abilities. Excellent written and oral communication skills.
Preferred Education: Master's degree Biotechnology Or Master's degree in related field(s)
Preferred Skills: 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. Extensive leadership experience.