cGMP Vector Manufacturing Associate

About the role

The USC Keck School of Medicine, current Good Manufacturing Practices (cGMP) facility is seeking a qualified cGMP Vector Manufacturing Associate to join the USC/CHLA cGMP Facility.

Responsibilities

• Performs cell culture, media preparation, cryopreservation, cell expansion, and viral vector production under strict cGMP guidelines.
• Executes aseptic processing, (e.g., cell seeding, passaging, harvesting, and transduction using viral vectors).
• Works closely with manufacturing, PD, QA, and QC teams to align processes, troubleshoot issues, and enhance efficiency.
• Assists in process optimization, scale-up, and validation to improve yield, efficiency, and reproducibility.
• Supports technology transfer from development to full-scale manufacturing.
• Performs data collection and analysis to refine production parameters and enhance process consistency.
• Conducts routine cleaning, calibration, troubleshooting, and maintenance of equipment and analytical instruments to ensure compliance with cGMP standards.
• Manages inventory of reagents, raw materials, and supplies, ensuring availability for seamless production and testing operations.
• Supports analytical testing for product release, stability, and in-process monitoring and support in assay qualification.
• Supports GMP documentation control, Corrective and Preventive Actions (CAPA) and change control processes to maintain quality standards.
• Affords assistance in internal and external audits, batch record review, and deviation investigations to uphold regulatory and quality standards.
• Affords assistance in training operators and new team members on manufacturing procedures, QC testing, and process development protocols.
• Maintains compliance with all safety protocols, regulatory requirements, and workplace standards.

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 Biotechnology and/or Biological Science
• Minimum Experience: 3 years

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).
• 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.

Pay

Salary Range: The hourly rate range for this position is $37.72 - $38.50 .

Schedule

N/A