Metrology Tech I

About the role

Legend Biotech is seeking a Metrology Tech as part of the Technical Operations team based in Raritan, NJ. This position will provide metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing, partnering with various Technical Operation functions to support personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The role will support the organization’s 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.

Responsibilities

• Provide 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.
• Plan, coordinate, and perform 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.
• Support the planning, coordination, and performance of timely calibration during shutdowns.
• Responsible for performance of IFM calibration outcomes; review CPI/KPI/GPI where applicable.
• Participate in the development of calibration data sheets, metrology job plans, and associated master plans.
• Participate in the development, implementation, and sustainment of emergency response programs and other safety programs.
• Assist 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 the optimization of calibration frequencies through a calibration interval management program, including minimally invasive instrumentation tasks that support calibration interval extension.
• Partner with stakeholders to 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 drive continuous improvement.
• Provide technical expertise 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.
• Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.
• Help 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.
• Minimum 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.
• 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, earn their respect and trust, and provide 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 the 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).
• Ability 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.

Pay

The base pay range is $83,711 USD – $109,870 USD. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits

• Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• Eight (8) weeks of paid parental leave after just three (3) months of employment.
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Voluntary benefits including flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.