cGMP Quality Control (QC) 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 the manufacturing of biologics and drugs for cell and gene therapy of internal/external users in the university's current Good Manufacturing Practices (cGMP) facility. The Quality Control (QC) Specialist is responsible for designing, developing, evaluating, and implementing quality control testing, assays, and procedures for materials and final cell therapy products manufacturing. The position will also be responsible for ensuring consistency with current Good Manufacturing Practice (cGMP) principles.

Job Accountabilities:

Supports cGMP manufacturing operations with responsibility for quality control. Performs cGMP batch release testing to ensure pharmaceuticals and biopharmaceuticals are of the highest possible quality before being applied to patients. Writes and reviews qualifications (e.g., installation, operation, performance), facility operation plans and reports, standard operating procedures, and batch records as required. Completes batch record documentation, all appropriate equipment log entries, and cGMP documentation. Operates instrumentation needed for cell and gene therapy manufacturing (e.g., cell counters, bioreactors, centrifuges, biological safety cabinets). Assists in technology transfer of manufacturing processes from pre-clinical into cGMP environment. Provides verification of facility operations and equipment, along with advanced problem-solving, troubleshooting, and consultation support, as needed. Supervises and directs junior staff to achieve project goals. Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects. Maintains confidentiality for patient identification, specimen labeling, and specimen verification during batch testing. Performs duties in a clean room environment, when needed and while fully gowned (e.g., mask, coverall, gloves), following cGMP guidelines and using aseptic techniques. Works with senior staff to ensure facilities' compliance with all applicable regulations. Attends routine meetings with the management team for progress reports on projects, facility needs, and discussion of any other required items. Improves current methods and evaluates innovative techniques in quality control testing for cell therapy and biologics. 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:

Bachelor's degree or higher in biotechnology or closely related 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. Extensive leadership experience.

Salary Range:

The annual base salary range for this position is $87,576.76 - $92,000. 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 candidate'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. This is a 3-year fixed-term position. 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:

Bachelor's degree

Minimum Experience:

3 years

Supervises:

May lead one or more employees performing similar work

Minimum Field of Expertise:

Bachelor's degree in a scientific discipline (e.g., pharmaceutical, biologics). Three years' experience in cellular or biological manufacturing with quality control responsibilities. Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs). Experience with standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work as an individual contributor and in a dynamic team environment. Excellent written and oral communication skills.

Preferred Education:

Master's Degree Preferred Experience:

5

Years Preferred Field of Expertise:

Biotechnology and life sciences 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. 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. 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 (213) 821-8100, or by email at uschr@usc.edu . Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: https://wd5.myworkday.com/usc/d/inst/1$9925/9925$125114.htmld