Operations Manager

Legend Biotech is seeking an Operations Manager (2nd Shift) as part of the Technical Operations team based in Raritan, New Jersey.

Role Overview

The CAR-T Operations 2^nd Shift Manager is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. This position is an onsite position working Monday to Friday on the 2^nd shift.

Key Responsibilities

• This individual will oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
• This individual will be a site management resources and point of contact for all 2^nd shift employees.
• This individual will be the primary point of contact for 2^nd shift Technical Operation’s supervisors of their respective areas of oversite.
• This individual will take direction and guidance from their Associate Director and or Senior Managers of the process areas
• This individual will also oversee the hiring, development, and performance management of staff, and assign personnel to execute daily production schedules.
• This individual will create/revise operational procedures, including manufacturing work instructions, master batch records, forms, etc.
• This individual will be responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.
• This individual will support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
• This individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
• This individual will also lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Establish key 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 5 years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 3 years supervisory experience. Cell/Gene Therapy experience preferred.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Clear and succinct verbal and written communication skills.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Basic project management skills, responsiveness to issues, and demonstrated passion for creating new medicines
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including daily overtime and weekends, as required by the manufacturing process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.
• Technology & Automation: Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.

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