cGMP Process Development (PD) Specialized Laboratory Technician

About the role

The cGMP Process Development (PD) Specialized Laboratory Technician at the USC/CHLA cGMP Facility supports process development activities related to the scale-up and optimization of cell therapy processes. This includes performing laboratory procedures, conducting quality control tests, maintaining equipment, and supporting technology transfer.

Responsibilities

• Performs moderate to complex laboratory procedures related to cell therapy development, including media preparation, cell expansion, harvesting, cryopreservation, and cell culture.
• Conducts quality control testing to ensure product safety, purity, and compliance, using 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.
• Executes laboratory experiments related to process development, preparing, operating, and cleaning equipment.
• Performs routine quality control tests and assays on materials, products, and processes to ensure compliance with standards.
• Monitors environmental conditions in cGMP cleanrooms, conducting viable and non-viable particulate monitoring and surface sampling.
• Maintains awareness of emerging laws, regulations, industry best practices, and advancements in cell therapy and cGMP manufacturing.
• 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.
• Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions.

Requirements

• 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.

Qualifications

• 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 development.
• Supervisory: 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.

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.

Benefits

N/A

Pay

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 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.

Schedule

Fixed-term position for 3 years.