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Operations Specialist

2 months ago

Raritan, New Jersey, United States Legend Biotech US Full time
{"Role Overview": "Operations Specialist

This position plays a critical role in ensuring the smooth operation of our cGMP Clinical and Commercial Cell Therapy Manufacturing plant. As an Operations Specialist, you will provide operational support to the Technical Operations team, partnering with them to drive and implement improvements in manufacturing operations. Your expertise will be essential in ensuring alignment with overall objectives and priorities of the plant.

", "Key Responsibilities": "
  • Provide general support to all Operating Areas, including Manufacturing, Warehouse, Logistics, and Support Labs.
  • Collaborate with Technical Operations to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation, and data management.
  • Partner with Operational Excellence to implement improvements.
  • Write, review, own, and update SOPs.
  • Own, provide assessments, and take actions in support of change controls.
  • Own CAPAs and associated project plans.
  • Support events such as Root Cause Analysis (RCAs) and FMEAs.
  • Participate in kaizens and other project initiatives.
  • Support any business improvement efforts.
  • Support permanent inspection readiness and actively support internal audits and regulatory inspections.
  • Provide input to studies related to process improvement and implementation of new manufacturing technologies and associated protocols.
  • Provide input and support improvements related to the aseptic environment and technique.
", "Requirements": "
  • BS/BA required in a technical discipline, such as Engineering, Science, or a similar field.
  • GMP Manufacturing, Warehouse, and Logistics experience in the biotech/biopharma industry, with Cell/Gene Therapy cGMP manufacturing experience preferred.
  • Fundamental understanding of Lean principles and tools, with Lean Six Sigma Green desirable.
  • 3+ years of experience leading and/or supporting improvement or remediation efforts.
  • Strong understanding and proven application of problem-solving tools and techniques.
  • Demonstrated experience owning SOPs, change controls, investigations, CAPAs, and other quality system actions.
  • Ability to engage all levels of the organization, from site leadership to the shop floor.
  • Proven experience working and leading in a matrix environment.
  • Able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
  • Strong ownership skills and ability to work independently.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Excellent organizational and communication skills.
", "Company Overview": "

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 and natural killer (NK) cell-based immunotherapy.

", "About Us": "

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel) in 2017. 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.

", "Equal Opportunity Employer": "

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

", "Drug-Free Workplace": "

Legend Biotech maintains a drug-free workplace.

", "Contact Us": "

Please note that we do not accept unsolicited resumes or applications. If you are interested in joining our team, please visit our website for available positions and application instructions.

", "Disclaimer": "

The information contained in this job description is accurate at the time of posting and may be subject to change.

", "Job Type": "Full-time"}