Global Process Steward

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 Global Process Steward as part of the Global MSAT team based in Raritan, NJ.

Role Overview

This position is a senior technical role in the global MSAT organization. This individual will be responsible for all technical scope for the approved Carvykti commercial process and overall program within Legend and with our program partner Janssen. This effort will extend to representing MSAT on joint technical and CMC committees. The candidate will also be required to collaborate within a cross functional team of experienced cell therapy professionals whose responsibility it is to deliver a best-in-class high volume marketed CAR-T product. This effort is business critical and part of a multi-site global manufacturing network whose aim is to maintain Legend’s competitive advantage in the Multiple Myeloma space. This individual is required to ensure the success and overall sustainability of global commercial program by adhering to industry best practices and sound cell therapy technical principles and deliver a process platform is robust and consistent. Portfolio management is required to implement process improvements, optimization, capacity expansion, and cost of goods / non-conformance reduction efforts worldwide.

Key Responsibilities  

• Represent MSAT at joint technical and CMC committees
• Partner closely with senior Janssen technical team to achieve global alignment on all technical Carvykti scope
• Provide technical direction and support of an expanding global manufacturing network for best-in-class CAR-T product.
• Work collaboratively with internal and external partners to drive global process platform improvements and cost reduction initiatives
• Drive strategy across multiple disciplines and functions to implement process changes / improvements, increase robustness, drive down OOS rates and improve delivery times to patients
• Ensure global alignment on process platform parameters, unit operations and analytical methods at both internal and external CMO sites for both cell and vector processes
• Ensure global records are consistent and maintained to achieve consistent performance worldwide for both Legend and partner sites.
• Provide technical support and leadership during Agency Inspections, filing of Submissions, and IRs.
• Maintain global master batch record and documentation on the platform process description and collaborate to the global change control process and global investigations.

Requirements

• B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field.
• Minimum 8 years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
• Extensive experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.
• Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
• Experience in a cross functional CMC team as a technical representative driving global commercial programs in cell therapy
• Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits
• Experience in implementing and managing commercial process improvements and changes
• Experience in driving consistency across multiple manufacturing sites.
• Experience in collaborating with external partners and CMOs preferred
• Extensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations support.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Results driven with strong analytical, problem solving and critical thinking skills.
• Strong experience working in a cross-functional organization with multiple partners with competing priorities.
• Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.

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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.