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 Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require proven leadership, technical expertise and troubleshooting ability to drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Provide technical expertise, train and manage an effective calibration program that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product
  
• Plan, coordinate, staff and prepare timely execution of daily activities related to calibration and instrumentation
  
• Ensure proper materials, tools, standards, parts and spare parts are identified and available
  
• Perform work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating procedures
  
• Coordinate, staff, prepare and support timely execution of shutdowns
  
• Support oversight of IFM calibration outcomes; reviews CPI/KPI/GPI where applicable
  
• Participate, manage or develop calibration data sheets, metrology job plans and associated master
  
• Participate in the development, implementation and sustainment of emergency response programs and other safety programs
  
• Assists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical documentation
  
• Conduct basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems
  
• Support and maintain the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extension
  
• Partner with stakeholders assist in defining user requirements for new instruments
  
• Responsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment
  
• Promote a collaborative work environment focused on an EHS first mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvement
  
• Provide technical and managerial leadership in area of responsibility by effectively interfacing and collaborating with key stakeholders and functions
  
• Actively participate in all regulatory and internal audits of the facility
  
• Participate in the hiring, development, and performance of the team
  
• Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines
  
• Help improve metrics performance to drive team results in areas of EHS, quality, compliance, cost, delivery and people
• Ability to interact with all levels within the organization: Operations, Quality, HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering, MS&T/Finance

Requirements

• B.Sc. in Biological/Biochemical Science/Bioengineering related field is required. Advanced degree is preferred.
• Must have minimum 8 years of experience in cGMP cleanroom manufacturing experience under aseptic conditions.
• Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA)
  
• Demonstrated ability to build effective and efficient teams and drive change within an organization
  
• Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow
  
• A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
  
• Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations
  
• Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment
  
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels
  
• Proven experience working and leading in a matrix environment
  
• Ability to lead with influence
  
• cGMP manufacturing
  
• Metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices
  
• Computerized maintenance management systems (CMMS)
  
• EHS and regulatory standards (e.g. EPA, OSHA and DEA)
  
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
  
• Strong analytical, problem solving and critical thinking skills
  
• Project management
  
• Change management
  
• Operational excellence, continuous improvement and lean manufacturing
  
• Excellent organizational and communication skills
  
• Transparent, Passionate, Fearless and Accountable
• Language: English

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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.