Metrology Tech I

Legend Biotech is seeking a Metrology Tech 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 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

• Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product.
• Plans, coordinates, and performs timely execution of daily activities related to calibration and instrumentation.
• Ensures proper materials, tools, standards, parts and spare parts are identified and available.
• Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating procedures.
• Supports the planning, coordination, and performance of timely calibration during shutdowns.
• Responsible for performance of IFM calibration outcomes; reviews CPI/KPI/GPI where applicable.
• Participates in the development of calibration data sheets, metrology job plans and associated master plans.
• Participates 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.
• Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.
• Helps support 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.
• Promotes 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.
• Provides technical expertise in area of responsibility by effectively interfacing and collaborating with key stakeholders and functions.
• Actively participates in all regulatory and internal audits of the facility.
• Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.
• Helps improve metric 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, Validation
  Qualification. 

Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

Requirements

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field. Trade / Technical School Certification or Certification in Craft required. Military equivalent of Trade / Technical School certification.
• Minimally 4+ 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).
• 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 being a member of high performing teams with a strong sense of mission.
• 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.

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