Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Operations Manager– Investigations and Compliance as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

The position is an exempt level position working within Technical Operations. This individual will be responsible for overseeing Operations related Investigations and general Compliance, as it relates to personalized cell therapy to support process requirements in a sterile cGMP environment.

Key Responsibilities  

• This individual will oversee and provide leadership and technical expertise within the Technical Operations group. The individual will partner with the Operations Management Team to ensure investigations and compliance initiatives are properly assessed and driven to completion.
• The individual will work closely with cross-functional teams to assess compliance risks due to investigations, observations, and findings related to manufacturing activities of the site’s cell therapy processes. This individual will work with the QA team onsite to ensure a compliance to GMP standards and improve Right First-time performance.
• Own various department projects to drive investigation reduction and compliance improvements and drive efficiencies within cell therapy Technical Operations. Develop methods to increase output while maintaining quality by maximizing operation capability and batch record execution.
• This individual will be involved in computerized systems such as Track Wise, Learning Management, Electronic Batch Record, and support implementation of any necessary updates. Support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. This individual will also oversee the hiring, development, and performance management of staff, and assign personnel to tasks.
• This individual will oversee creation/revision of operational procedures, including manufacturing work instructions, master batch records, forms, etc.

Key Relationships

• Establish key stakeholder relationships with internal and external stakeholders.
• Ability to interact with all levels within the organization. 

Requirements

• Bachelor’s degree in engineering or related field or equivalent experience required. 
• A minimum of 10 years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of people leader experience.
• A minimum of 2 years in Cell/Gene Therapy experience and Lean Manufacturing qualifications a plus. 

#LI-NP

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.