Contamination Program Lead

Job Description

Legend Biotech is seeking a Contamination Program Lead to join their Technical Operations team in Raritan, New Jersey. The Contamination Program Lead will spearhead the creation and maintenance of the contamination control strategy program for the Cell Therapy facility, ensuring compliance with FDA and Annex 1 requirements. This role involves cross-functional collaboration to ensure proper disinfection and maintenance of equipment and the facility's environmental control.This individual will be an integral part of the CAR-T Environmental Monitoring Immediate Action team and Contamination Rapid Response Team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Responsibilities:

• Establish and maintain the contamination program/strategy for the site.
• Ensure program alignment across the network and present the strategy during health authority inspections.
• Assess change controls, risk assessments, trend reports, and SOPs/Work Instructions for contamination impact.
• Support significant Environmental Monitoring and Sterility related investigations.
• Support facility expansion activities, ensuring a robust contamination approach.
• Support training on proper contamination/disinfecting of equipment/personnel.

Requirements:

• Bachelor’s Degree in Engineering or Microbiology.
• 8+ years of experience in Technical, Engineering, or Operations in a GMP production environment.
• Experience conducting, supporting, reviewing, and approving cleaning efficacy studies.
• Experience in biotechnology or Cell Therapy preferred.
• Strong organizational skills and microbial background.
• In-depth knowledge of cleaning/sanitizing agents.
• Ability to work independently, prioritize tasks, and integrate cross-functional requirements.
• Experience with relevant regulatory requirements including in EU GMP Annex 1.
• Excellent communication skills and ability to influence decision-making.
• Must be willing to work a hybrid schedule: (At least 3-4 days on site per week)

What This Role Offers:

• Opportunity to lead and maintain a critical contamination control program.
• Cross-functional collaboration with various departments.
• Involvement in facility expansion activities.
• Contribution to ongoing clinical and commercial manufacturing.