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

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

Requirements

• BS/BA required in technical discipline: Engineering, Science, or similar field.
• GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Demonstrated experience owning and driving SOPs, change controls, investigations, CAPAs and other quality system actions to completion.
• Strong understanding and proven application of problem-solving tools and techniques.
• Fundamental understanding of Lean principles and tools, Lean Six Sigma Green is desirable.
• 3 years of experience leading and/or supporting improvement or remediation efforts is desirable.
• Proven 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.

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