Operations Specialist Jobs

Company Information

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.

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) 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.

Legend Biotech is seeking Operations Specialist as part of the Technical Operations team based in Raritan, New Jersey.

Role Overview

This position will be responsible for providing operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Technical Operations in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for driving and implementing a wide variety of improvements, ensuring alignment in support of the overall objectives and priorities of the plant. The role will require communication, coordination, and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Participates in kaizens and other project initiatives and works with other functional areas to drives these initiatives to completion.
• Provides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocols.
• Provides and/or gathers assessments and takes ownership actions to drive change controls to completion.
• Partners with Operational Excellence to implement operational, process, and business improvements.
• Provides input and supports improvements related to the aseptic environment and personnel technique.
• Provides general support to all Operating Areas, e.g. Manufacturing, Warehouse, Logistics, Support Lab, Cryopreservation, and Operational Excellence.
• Supports routine inspection readiness and actively supports internal audits and regulatory inspections.
• Owns Operations related CAPAs and associated project plans.
• Supports events such as Root Cause Analysis (RCAs) and FMEAs.
• Collaborates with Technical Operation teams responsible for providing process knowledge and expertise in support of GMP investigations, change controls, document revisions, study protocols, process improvement, process validation and data management.
• Supports any operational, process and business improvement efforts.
• Owner and driver of and MBRs, SOPs, and Forms updates to meet established timelines.

Requirements

• Fundamental understanding of Lean principles and tools, Lean Six Sigma Green is desirable.
• Proven ability to engage all levels of the organization, from site leadership to the shop floor
• Excellent organizational and communication skills.
• 3+ years of experience leading and/or supporting improvement or remediation efforts is desirable.
• Strong understanding and proven application of problem-solving tools and techniques.
• BS/BA required in technical discipline: Engineering, Science, or similar field.
• 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.
• Proven experience working and leading in a matrix environment.
• GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Strong analytical, problem solving and critical thinking skills.
• Demonstrated experience owning and driving SOPs, change controls, investigations, CAPAs and other quality system actions to completion.

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.

Legend Biotech maintains a drug-free workplace.

Benefits:

• Health Insurance
• Pet Insurance
• Dental Insurance
• Life Insurance
• Critical Illness Insurance
• Long-Term Disability
• Vision Insurance
• Matched 401K
• AD&D Insurance
• Hospital Indemnity Insurance
• Flexible Spending Account
• Short-Term Disability
• Employee Assistance Program
• Commuter Benefits
• Accident Insurance
• Paid Paternity Leave
• Legal Insurance
• Health Savings Account
• Paid Maternity Leave