Knowledge Operations Manager Jobs in Mendham, NJ

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 2nd 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 2nd 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 2nd shift employees.
• This individual will be the primary point of contact for 2nd 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.

#Li-RN1

#Li-Onsite