Operations Support Specialist II

Legend Biotech US•Raritan, NJ
•$47,861 - $62,819•Onsite

About The Position

Legend Biotech is hiring an Operations Support Specialist II for its Manufacturing & Supply team in Raritan, New Jersey. The CAR-T Operations Support Specialist will join Technical Operations and support production of personalized cell therapy for clinical and commercial needs in a sterile cGMP environment. Work is performed as part of a team according to an assigned production shift schedule. Duties routinely involve exposure to and handling of biological materials and hazardous chemicals.

Requirements

  • Bachelor’s degree in engineering or a related field, or equivalent experience.
  • 0–1 years of operations experience in a cGMP environment in the biotech or biopharma industry.
  • Ability to build strong partnerships and effectively integrate with external collaborators to advance projects and programs in a matrixed environment.
  • Ability to work independently, prioritize and manage multiple tasks, integrate cross-functional issues, and balance competing priorities.
  • Clear, succinct verbal and written communication skills, attention to detail, and ability to follow procedures.
  • Knowledge of cGMP regulations and FDA guidance related to manufacturing cell-based products.
  • Ability to lift at least 50 lbs and stand for extended periods.
  • Sufficient vision and hearing to work in the job environment, and physical dexterity to use computers and document production records.
  • Ability to handle human-derived materials in a BSL-2 cleanroom facility.
  • Ability to work shifts, including evenings and weekends, as required by the manufacturing process.
  • Ability to accommodate unplanned overtime with little or no prior notice.
  • Must be authorized to work in the United States.

Responsibilities

  • Perform process unit operations, including cell culture, purification, aseptic processing, and cryopreservation, according to standard operating procedures and batch records.
  • Record production data and information clearly and concisely.
  • Complete tasks on time in accordance with safety policies, quality systems, and cGMP requirements.
  • Partner with Manufacturing, Engineering, and Quality and work cross-functionally to complete production tasks required by the shift schedule.
  • Support manufacturing process development and collaborate on continuous improvements and efficiencies within cell therapy Technical Operations.
  • Handle biological materials and hazardous chemicals as required by routine job duties.

Benefits

  • Medical, dental, and vision insurance.
  • 401(k) retirement plan with a company match that vests fully on day one.
  • Eight weeks of paid parental leave after three months of employment.
  • Paid time off including vacation, personal time, sick time, floating holidays, and eleven company holidays.
  • Flexible spending and health savings accounts.
  • Life and AD&D insurance.
  • Short- and long-term disability coverage.
  • Legal assistance.
  • Supplemental pet, critical illness, accident, and hospital indemnity insurance plans.
  • Voluntary commuter benefits.
  • Family planning and care resources.
  • Well-being initiatives.
  • Peer-to-peer recognition programs.
  • Performance-based bonus and/or equity for employees in eligible roles.
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