cGMP Process Development (PD) Specialized Laboratory Technician

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

Job summary

An innovative institution is looking for a dedicated cGMP Process Development Technician to support the development of cutting-edge cell and gene therapies. This role involves executing laboratory experiments, maintaining equipment, and ensuring compliance with regulatory standards. You will play a crucial part in advancing scientific research and manufacturing processes, contributing to the future of medicine. Join a collaborative team where your expertise will help shape the future of healthcare and improve patient outcomes through groundbreaking therapies.

Qualifications

• 2+ years of experience in cell therapy development.
• Knowledge of FDA and EMA regulatory guidelines.

Responsibilities

• Support process development activities and laboratory experiments.
• Maintain laboratory equipment and ensure compliance with cGMP guidelines.

Skills

Laboratory Equipment Proficiency

Attention to Detail

Communication Skills

Teamwork

Troubleshooting Skills

Education

Bachelor's degree in Biological Science

Master's degree in Biotechnology

Tools

cGMP Manufacturing Equipment

Flow Cytometry

Job description

cGMP Process Development (PD) Specialized Laboratory Technician

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Keck School of Medicine, Los Angeles, California

The University of Southern California (USC), founded in 1880, is located in downtown LA and is the largest private employer in the city. USC's Keck School of Medicine is seeking a dedicated individual for the cGMP Process Development (PD) Specialized Laboratory Technician role, focusing on process development and manufacturing of cell and gene therapies and other biological products.

Role Responsibilities:

1. Support process development activities, including executing laboratory experiments, equipment preparation, routine testing, and data documentation for process optimization and development.
2. Maintain laboratory equipment, manage inventory, and ensure all equipment is calibrated and operational.
3. Assist in technology transfer from development to manufacturing, ensuring compliance with cGMP guidelines.
4. Perform laboratory procedures related to cell therapy development, such as media preparation, cell expansion, harvesting, cryopreservation, and quality control testing (sterility, endotoxin, mycoplasma, flow cytometry).
5. Conduct environmental monitoring and ensure adherence to SOPs and regulatory standards, maintaining a safe and compliant work environment.
6. Gather, record, and analyze data accurately; support process improvements and optimization efforts.
7. Stay informed about industry regulations, best practices, and advancements in cell therapy and cGMP manufacturing.
8. Promote an inclusive and ethical work environment.
9. Perform additional duties as assigned, with the understanding that responsibilities may evolve.

Candidate Requirements:

• Bachelor's degree in Biological Science or Biotechnology; Master’s preferred.
• Minimum 2 years of experience in cell therapy development; 3 years preferred.
• Proficiency with laboratory equipment used in cGMP manufacturing and quality control.
• Strong attention to detail, adherence to SOPs, and knowledge of regulatory guidelines (FDA, EMA).
• Excellent communication, teamwork, and troubleshooting skills.

Additional Details:

• Salary range: $26.50 - $29.81 per hour.
• This is a fixed-term position for 3 years.
• May supervise students, temporary, or resource workers.

USC considers all qualified applicants, including those with criminal records, in accordance with applicable laws and regulations.