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cGMP Process Development (PD) Specialized Laboratory Technician

University of Southern California

Job Accountabilities Perform moderate to complex laboratory procedures related to cell therapy development, including media preparation, cell expansion, harvesting, cryopreservation, and cell culture. Conduct quality control testing to ensure product safety, purity, and compliance, using methods such as sterility testing, endotoxin assessment, mycoplasma detection, and flow cytometry. Support cGMP manufacturing activities by performing aseptic techniques in a fully gowned cleanroom environment. Assist in executing laboratory experiments related to process development (preparing, operating, and cleaning equipment). Perform routine quality control tests and assays on materials, products, and processes. Conduct environmental monitoring in cGMP cleanrooms (viable/non‑viable particulate monitoring and surface sampling). Follow established SOPs and regulatory guidelines, ensuring compliance with cGMP and safety protocols. Prepare, calibrate, and maintain laboratory equipment; participate in routine maintenance and keep a clean, safe, organized environment. Monitor inventory of lab supplies and materials, ensuring adequate stock and timely ordering. Collect, document, and record data accurately in detailed electronic records. Assist with technology transfer activities, ensuring smooth transition of processes between development and manufacturing. Support process optimization efforts by gathering and analyzing data from experiments and production runs. Engage in professional development and training to enhance skills and stay updated with industry standards. Promote an inclusive working environment, fostering unbiased opportunities. Successful Candidates Must Demonstrate Bachelor's degree in Biological Science or Biotechnology (minimum). Master’s degree preferred. Minimum 2 years in cell therapy development (3 years preferred). Demonstrated knowledge of biotechnology, cell therapy, FDA regulations, and clinical trials. Strong communication and writing skills, with the ability to work independently and as part of a dynamic team. Proficiency in operating and maintaining laboratory equipment used in cGMP manufacturing and quality control testing. Strong attention to detail and adherence to SOPs and quality assurance principles. Ability to troubleshoot and resolve technical issues promptly. Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) related to cGMP. Ability to supervise students, temporary staff, or resource workers if required. Salary Range and Employment Details Hourly rate: $26.50 – $29.81. 3‑year fixed‑term position. Additional Information 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. The university will consider applicants with criminal records in a manner consistent with applicable laws. Background screening requirements are described in the USC Background Screening Policy AppendixD. USC provides reasonable accommodations to applicants and employees with disabilities. #J-18808-Ljbffr University of Southern California

Vacancy posted 5 days ago
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