Manufacturing Lead Operator

The role

This individual will produce personalized cell therapy in a sterile cGMP environment. They will perform process unit operations including cell culture, purification, aseptic processing, and cryopreservation.

What you will do

• Establish effective time management and prioritization of job requirements.
• Support the development of CAR-T manufacturing processes.
• Work with technical support and engineering personnel to drive continuous improvements.
• Provide general production floor oversight in ISO 5 and ISO 7 environments.
• Perform process unit operations including cell culture, purification, aseptic processing, and cryopreservation.
• Record production data and information in a clear, concise format.
• Troubleshoot patient specific product issues to ensure continuous flow of operations.
• Establish key stakeholder relationships with internal and external stakeholders.

Required qualifications

• Bachelor’s degree in life science/engineering, or related field or equivalent experience
• Minimum of 2 years of operations experience within a cGMP environment in the biotech/biopharma industry
• Prior experience in manufacturing, maintenance, quality, testing, or engineering
• Ability to build strong partnerships and integrate with external collaborators
• Ability to work independently and manage multiple tasks simultaneously
• Clear and succinct verbal and written communication skills
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products
• Ability to lift a minimum of 50 lbs
• Ability to stand for a long period of time
• Sufficient vision and hearing capability to work in job environment
• Physical dexterity sufficient to use computers and document production records
• Ability to handle human derived materials in BSL-2 cleanroom facility

Nice to have

• Prior experience in an aseptic manufacturing environment

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight weeks of paid parental leave after three months of employment
• Paid time off including vacation, personal, sick, floating holidays, and eleven company holidays
• Flexible spending and health savings accounts
• Life, AD&D, short-term and long-term disability coverage
• Legal assistance
• Supplemental plans including pet, critical illness, accident, and hospital indemnity insurance
• Commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States
• Participation in the E-Verify program

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company is advancing the next generation of cell therapy.