Senior Manager/Associate Director, External Manufacture

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 a Senior Manager/Associate Director, External Manufacture as part of the Global Manufacturing Supply team based in Raritan, NJ.

Role Overview

This position will be responsible for managing the technical transfer and clinical/commercial manufacture of cell therapy products in our external manufacture organization. He/she will be the business owner of the project: overseeing the project, driving the deliverables, managing the risks, and updating the senior leadership and stakeholders on the status and plans. This position will also serve as a liaison between CMO, internal functional groups, and our partner JNJ. The position will require excellent business acumen and strong technical expertise.

Key Responsibilities

• Manage and oversee all the CMO activities from apheresis delivery till timely DP shipment. Ensure flawless and timely execution of the production plan at the CMO’s.
• Leads the management review process with CMO’s based on agreed KPI’s
• Drives and steers continuous improvement at the CMO and ensure timely execution of capacity, Tech Transfer and improvement projects.
• Establish and manage excellent working relationship with internal stakeholders and external partners.
• Manage the CMO tech transfer and clinical/commercial manufacture: trouble shooting problems, conducting investigations, track timeline and KPIs, overseeing capacity expansion, monitoring budget, driving cost reduction and quality improvement and serve as Person in Plant.
• Serve as the liaison between internal functional groups, such as global MS&T, Supply Chain, Technical Development, Quality and the CMO teams to collaboratively drive the deliverables and timelines
• Conduct risk and gap analysis, maintain risk registry and develop mitigation strategies.
• Provide timely and accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager and cross functional stakeholders.
  
  
  

Requirements

• B.S. or more advanced degree is required, in related technical disciplines: engineering, biological science, pharmaceutical science etc.
• Minimum 5+ years of industrial biologics CMC development or manufacturing experience, Cell therapy manufacture experience is desirable.
• Minimum 3+ years of experience in independently managing a CMO project is required.
• Excellence skill in relationship management
• Results driven with strong analytical, problem solving and critical thinking skills.
• Experience in a fast-paced and dynamic environment.
• Excellent time-management, organizational and communication skills.
• Strong business acumen and change management experience.
  
  
  

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.

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Matched 401K
• Flexible Spending Account
• Health Savings Account
• AD&D Insurance
• Short-Term Disability
• Long-Term Disability
• Paid Maternity Leave
• Paid Paternity Leave
• Pet Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Accident Insurance
• Legal Insurance
• Commuter Benefits
• Employee Assistance Program