Sr. Manager, Maintenance & Metrology

Legend Biotech is seeking a Sr. Manager, Maintenance & Metrology as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for maintenance and metrology support and mechanical system operations 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

• Leads, directs, coaches and develops an effective maintenance and metrology team that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product.
• Manages, plans, coordinates, staffs and prepares timely execution of daily activities related to facility operation, calibrations and corrective, preventative and predictive maintenance and repair.
• Ensures proper materials, 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.
• Manages, plans, coordinates, staffs and prepares timely execution of shutdowns.
• Participates or develops Cals, PMs, job plans and/or master data.
• Establishes and oversees Lock Out/Tag Out programs, Hot Work permits, confined space entry programs, emergency response programs and other safety programs.
• Assists in the creation, tracking and completion of maintenance related quality events, CAPAs, and Out of Tolerance (OOT) situations.
• Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.
• Provides input in the development & execution strategy of calibrations (Cals), preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards.
• 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 and managerial leadership in area of responsibility by effectively interfacing and collaborating with key stakeholders and functions.
• Leads and actively participates in all regulatory and internal audits of the facility.
• Oversees the hiring, development, and performance management of team.
• Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.
• Develops metrics to drive team results in areas of EHS, quality, compliance, cost, delivery and people.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• 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./M.Sc. in Biological/Biochemical Science/Bioengineering related field or equivalent job experience.
• Minimally 8+ years of experience in cGMP cleanroom manufacturing experience under aseptic conditions.
• Technical knowledge in maintenance/metrology management, broad understanding of facilities management, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA).
• Strong knowledge of HVAC operation, building automation and environmental monitoring systems, process maintenance, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience.
• 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.
• Maintenance, metrology and facilities management.
• Computerized maintenance management systems (CMMS).
• EHS and regulatory standards (e.g. EPA, OSHA and DEA).
• HVAC operation, building automation and environmental monitoring systems, process maintenance, instrumentation, automation PLCs, VFDs and electrical practices.
• 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.

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