Operations Specialist

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

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 Labs.
• Collaborates with Technical Operations who are responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data management.
• Partners with Operational Excellence to implement improvements.
• Writes, reviews, owns and updates SOPs.
• Owns, provides assessments and takes actions in support of change controls.
• Owns CAPAs and associated project plans.
• Supports events such as Root Cause Analysis (RCAs) and FMEAs.
• Participates in kaizens and other project initiatives.
• Supports any business improvement efforts.
• Supports permanent 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 technique.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8. 

• 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.
• Fundamental understanding of Lean principles and tools, 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 ownings 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.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.
• Physical dexterity sufficient to use computers and documentation.
• Solution-oriented mentality, capable of developing new procedures and alternate paths to overcome identified opportunities for improvement. 

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