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Legend Biotech is seeking an Operations Supervisor as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Key Responsibilities

• This individual will lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• This individual will lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
• This individual's primary responsibility will be to work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• This individual will support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
• This individual will work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• This individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• This individual will support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
  • Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
  • Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
  • Color Perception both eyes 5 slides out of 8
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

Requirements

• Bachelor's degree in Science, Engineering or related field or equivalent experience required.
• A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required. Excellent communication and organizational behaviors skills are required. Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required. Availability to work in a day shift (1st or 2nd shift) is required.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
• Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
• 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.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records.
• A working leader who can participate in production runs in critical situations when needed.
• Ability to lift a minimum of 25 lbs. and stand for a long period of time.

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