Operations Supervisor

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,
 T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From
 our three R&D sites around the world, we apply these innovative technologies to
 pursue the discovery of safe, efficacious and cutting-edge therapeutics for
 patients worldwide.

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). 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 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.…