Legendcareers
Operations Supervisor
Raritan, New Jersey, United States. Posted 3 months ago
The role
The CAR-T Operations Supervisor directs the daily production of personalized cell therapy in a sterile cGMP environment. This role involves leading production units, supervising personnel, and supporting manufacturing investigations.
What you will do
- Lead and supervise multiple units within the CAR-T process operations.
- Ensure safe and compliant manufacturing operations according to cGMP requirements.
- Lead daily start of shift and wrap up production meetings.
- Assign individuals their daily production tasks.
- Provide guidance and perform production tasks on the production floor.
- Support manufacturing investigations.
- Create and revise operational procedures, work instructions, and master batch records.
- Manage change controls.
- Oversee the development of production personnel and provide input on performance.
- Partner with Manufacturing, Engineering, and Quality to address production issues.
Required qualifications
- Bachelor’s degree in Science, Engineering or related field or equivalent experience
- Minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry
- Prior experience in manufacturing, quality, or engineering
- Excellent communication and organizational behaviors skills
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook)
- Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors
- Strong Leadership skills
- Ability to work independently and manage multiple tasks simultaneously
- Strong analytical, problem solving and critical thinking skills
- Ability to lift a minimum of 25 lbs.
- Stand for a long period of time
- English language proficiency
Nice to have
- Experience with Operational Excellence and/or Lean Manufacturing
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 and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans including pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives and peer-to-peer recognition programs
Before you apply
- Applicants must be authorized to work in the United States
- Employment eligibility will be verified through E-Verify
About the company
Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. The company is advancing the next generation of cell therapy through a portfolio of innovative technologies.