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Technical Operations Support Associate

2 months ago


Raritan, New Jersey, United States Legend Biotech US Full time
Company Overview

Legend Biotech is a pioneering global biotechnology firm focused on addressing and ultimately curing life-threatening illnesses. With our headquarters in Somerset, New Jersey, we are at the forefront of developing advanced cellular therapies utilizing a variety of technological platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

In 2017, Legend Biotech established a global collaboration with Janssen, a subsidiary of Johnson & Johnson, to co-develop and commercialize ciltacabtagene autolecuel (cilta-cel). This strategic alliance aims to leverage the strengths and expertise of both organizations to enhance the potential of immunotherapy in treating multiple myeloma.

Legend Biotech is currently seeking an Operations Support Specialist to join the Technical Operations team.

Position Summary

The Operations Support Specialist will be an integral member of the Technical Operations team, responsible for the production of personalized cell therapies that meet both clinical and commercial needs within a sterile cGMP environment. The role involves working within a team on an assigned production shift schedule.

Key Responsibilities
  • Assist in process operations by executing specific support tasks and real-time floor service activities (e.g., kitting and kit cleaning, inventory oversight, data entry, sample management, and aseptic practices for equipment cleaning and cryopreservation) in accordance with standard operating procedures and batch records, while meticulously documenting production data.
  • Ensure timely task completion while adhering to safety protocols, quality systems, and cGMP standards.
  • Foster strong collaborations with Manufacturing, Warehouse, Engineering, and Quality teams, contributing as part of a cross-functional group to fulfill production requirements as per the shift schedule.
  • Contribute to the enhancement of manufacturing processes and collaborate with colleagues to drive continuous improvements and efficiencies within cell therapy Technical Operations.
Qualifications
  • High School Diploma with relevant experience required; or a Certificate or Associate's degree in a scientific or health services field preferred, with a Bachelor's degree in a related field being advantageous.
  • A minimum of 0-1 years of operational experience in a cGMP setting within the biotech or biopharma sector.
  • Proficient in computer skills to navigate specialized software and databases.
  • Ability to cultivate strong partnerships and effectively collaborate with external stakeholders to advance projects in a matrixed environment.
  • Capability to work independently, prioritize tasks, and manage multiple responsibilities simultaneously while addressing cross-functional issues and balancing competing priorities.
  • Excellent verbal and written communication skills with a keen attention to detail and adherence to procedures.
  • Familiarity with cGMP regulations and FDA guidelines pertaining to the manufacturing of cell-based products.
  • Physical ability to lift a minimum of 50 lbs. and maintain standing positions for extended periods.
  • Vision and hearing capabilities sufficient to operate in a job environment, along with physical dexterity to use computers and document production records.
  • Ability to handle human-derived materials in a BSL-2 cleanroom setting.
  • Physical dexterity to operate computers and maintain documentation.
  • Willingness to accommodate shift work, including evenings and weekends, as dictated by the manufacturing process.
  • Flexibility to manage unplanned overtime with minimal notice.


Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We ensure equal employment opportunity without discrimination or harassment based on various characteristics protected by law.

Legend Biotech maintains a drug-free workplace.