cGMP Process Development (PD) Specialized Laboratory Technician

University of Southern California (USC); Los Angeles (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

The University of Southern California (USC) is seeking a cGMP Process Development Specialized Lab Technician. This role involves supporting cell and gene therapy development through laboratory procedures, quality control testing, and technology transfer, requiring a specialized scientific degree and experience in the field.

Qualifications

• 2-3 years in cell therapy development required.
• Strong communication skills and ability to work in teams essential.
• Familiarity with FDA and cGMP regulations needed.

Responsibilities

• Execute laboratory experiments related to process development.
• Conduct quality control tests to ensure compliance.
• Maintain and calibrate laboratory equipment.

Skills

Attention to detail

Teamwork

Problem-solving

Education

Bachelor's degree in Biological Science or Biotechnology

Master's degree (preferred)

Tools

Laboratory equipment used in cGMP manufacturing

Job description

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 comprises the faculty, students and staff that make the university what it is.

USCs Keck School of Medicine, current Good Manufacturing Practices (cGMP) facility is seeking a dynamic individual to work on the process development and manufacturing of cell and gene therapies and other biological products for internal/external users. The cGMP Process Development (PD) Specialized Lab Technician at the USC/CHLA cGMP Facility is responsible for supporting process development activities related to the scale-up and optimization of cell therapy processes. The role involves assisting in the execution of laboratory experiments, preparing equipment, performing routine testing, and collecting and documenting data for process optimization and development studies. The Process Development (PD) Specialized Lab Tech helps set up process development labs, maintains inventory, and ensures all equipment is calibrated and ready for use. Additionally, this role supports the technology transfer process from development to manufacturing and ensures compliance with cGMP guidelines.

Job Accountabilities

• Performs moderate to complex laboratory procedures related to cell therapy development. Utilizes specialized techniques and technology to achieve results (e.g., media preparation, cell expansion, harvesting, cryopreservation, and cell culture) and conducts quality control testing to ensure product safety, purity, and compliance, utilizing methods such as sterility testing, endotoxin assessment, mycoplasma detection, and flow cytometry. Supports cGMP manufacturing activities by performing aseptic techniques in a fully gowned cleanroom environment. Assists in executing laboratory experiments related to process development (e.g., preparing, operating, cleaning equipment).
• Performs routine quality control tests and assays on materials, products, and processes to ensure compliance with standards. Conducts environmental monitoring in cGMP cleanrooms (e.g., viable and non-viable particulate monitoring and surface sampling). Follows established SOPs and adheres to regulatory guidelines, ensuring compliance with cGMP and safety protocols. Maintains awareness of emerging laws, regulations, industry best practices, and advancements in cell therapy and cGMP manufacturing.
• Prepares, calibrates, and maintains laboratory equipment for use. Participates in routine lab maintenance and ensures a clean, safe, and organized working environment across all departments. Monitors inventory of lab supplies and materials, ensuring sufficient stock for ongoing operations and timely ordering.
• Collects, documents, and records data accurately, maintaining detailed and organized electronic records. Assists with technology transfer activities, ensuring smooth transition of processes between development and manufacturing. Supports process optimization efforts by gathering and analyzing data from experiments and production runs.
• Stays up to date with the latest advancements, regulations, and best practices in cell therapy and cGMP manufacturing. Engages in professional development and training to enhance skills and ensure compliance with evolving industry standards.
• 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.

Salary Range:

The hourly rate range for this position is $26.50 - $29.81. 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.

*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 in Biological Science And/Or Biotechnology Minimum Experience: 2 years in cell therapy development Preferred Education: Master's degree Preferred Experience: 3 years in cell therapy developmentSupervisory: May supervise student, temporary and/or resource workers.Minimum Skills: Proficiency in operating and maintaining laboratory equipment used in cGMP manufacturing and quality control testing. Strong attention to detail and ability to follow standard operating procedures (SOPs) and quality assurance principles meticulously. Excellent communication and teamwork skills to collaborate effectively with cross-functional teams. Ability to troubleshoot and resolve technical issues in a timely manner. Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) related to cGMP.

Quick Apply Link: https://usccareers.usc.edu/job/-/-/1209/78605378672