Operations Manager

Responsibilities

• Oversee cell therapy production and ensure safe, compliant manufacturing operations according to cGMP requirements
• Serve as the primary point of contact and site management resource for all 2nd shift employees and supervisors
• Manage hiring, development, and performance of staff while assigning personnel to daily production schedules
• Create and revise operational procedures, manufacturing work instructions, and master batch records
• Support manufacturing investigations, change controls, and maintain inspection readiness for regulatory audits
• Build partnerships with Manufacturing, Engineering, and Quality teams to ensure seamless production execution
• Lead facility operating review meetings and drive continuous improvement projects

Requirements

• Bachelor’s degree in Engineering or a related field, or equivalent experience
• Minimum 5 years of operations experience in a cGMP biotech/biopharma environment
• Minimum 3 years of supervisory experience
• Deep understanding of FDA, EMA, and global regulatory requirements for pharmaceutical manufacturing
• Familiarity with modern manufacturing systems such as MES and ERP
• Ability to work 2nd shift, including daily overtime, weekends, and unplanned overtime as required
• Strong analytical, problem-solving, and project management skills

Preferred Qualifications

• Experience in Cell and Gene Therapy
• Experience with Operational Excellence or Lean Manufacturing

About the Company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies, including CAR-T, TCR-T, and NK cell-based immunotherapies.