Legend Biotech is seeking a Sr. Master Data Governance Specialist as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

We are actively seeking a proficient Sr. Master Data Governance Specialist with a specific focus on SAP Extended Warehouse Management (EWM) master data and materials orchestration throughout the End-to-End Manufacturing & Supply lifecycle. This role is pivotal in leading the design and execution of the Global Manufacturing & Supply (GMS) data governance process, from material creation to consumption across Warehouse, Materials Planning, Work Centers, Bill of Materials / Recipes, Costing and Quality Inspection attributes. This role will partner with the IT team and collaborate in the design-implementation of Legend's Master Data Management program. We are looking for a well-organized and process-oriented leader, with strong understanding of Manufacturing & Supply Chain Management operations, who can translate operational and technical data requirements into actionable programs and activities supporting execution of SAP day-to-day production processes.

The ideal candidate has expertise in developing and implementing data process workflows, identification / segmentation of core manufacturing and material data objects, and expertise in deployment of SAP MDG, especially EWM master data and inclusive but not limited to MM, SD, FI, etc., particularly within the biotech industry. As the functional GMS Data Specialist, you will play a vital role in executing and overseeing the BUILD and RUN operational aspects of SAP data creation within Legend's Manufacturing network.

Your role will involve collaborating with cross-functional business teams, IT and SAP Integration partners to define and optimize business processes, create data migration/conversion activities, and ensure adherence to regulatory requirements, including SoX, and CFR Part 21 and GxP as applicable. By driving the successful delivery of SAP solutions, you will contribute to the seamless operation of critical data processes within Legend Biotech.

Key Responsibilities

• Your primary role will be to design, implement, and deploy a global standard and data creation workflow process that supports GMS business activities, and in line with IT's MDG template.
• Utilize your extensive master data expertise to demonstrate a profound understanding of SAP EWM master data and configuration elements, MDG Materials, BOM, Recipes, MRP, MPS, Work Centers, Batch Management, Quality Inspection, Costing, among others.
• Collaborate with business stakeholders, collaboration partners, and business process owners to conduct comprehensive analysis on all GMS material management aspects addressing data creation, data quality, governance needs and dealing with all data interconnectivity with other systems.
• Build and drive plans to improve data practices for operational, reporting and analysis needs – Inclusive of development of processes, control, and best business practices around data management.
• Build organization understanding of data lifecycles from creation to end use, working with subject matter experts in various business functions, operations, and IT teams.
• Create and maintain process maps, data objects, and user guides, to ensure a comprehensive knowledge base.
• Manage and support all site-specific projects with respect to new product launches, alternate material sources, alternate BOM/recipes, etc. and collaborate on required change control deliverables where applicable.
• Provide expert-level support for SAP MDG modules, addressing functional issues, incidents, and change requests. Work closely with the support team to prioritize and resolve tickets efficiently.
• Oversee change management procedures, including business engagement, impact analysis, documentation review and approval, user testing reviews, and ensure smooth and controlled changes to minimize risks and disruptions associated with GMS activities.
• Identify opportunities for process improvement and optimization within the MDG areas, leveraging SAP functionalities and best practices to drive efficiency and effectiveness while maintaining regulatory compliance.
• Embrace and promote Agile principles and values within the team and projects, fostering a culture of continuous improvement and iterative development.
• Create an environment that encourages open communication, teamwork, and innovation, contributing to a positive and collaborative work culture.

Requirements

• Minimum of 5 years' experience in SAP MDG - Material Master, Planning, Procurement, Vendors Data Objects, Customer, Vendor, etc.
• Minimum of +3 years developing and implementing MDM solutions and data governance processes, including hands-on design and configuration
• Experience with leading business process reengineering and business process assessment.
• Exceptional communication and interpersonal skills, with the aptitude to effectively engage and influence stakeholders at all levels.
• Demonstrated capability to lead and manage cross-functional teams, fostering collaboration, and achieving high-performance outcomes; demonstrated ability to lead and manage change initiatives while driving organizational transformation.
• Advanced technical knowledge of SAP EWM Master Data specifically and in at least two (2) of the Production, Materials Management, and/or Quality modules

This position is designed as a hybrid role; however, we are also open to considering fully remote candidates.

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

Role Overview

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Shift Options Available:

• Wed–Sat, 2nd Shift

Key Responsibilities

• Lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
• Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
• Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• 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. 

Requirements

• Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
• A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Availability to work in a day shift (1st or 2nd shift) is required.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
• Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be 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 and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records
• A working leader who can participate in production runs in critical situations when needed.
• Ability to lift a minimum of 25 lbs. and stand for a long period of time. 

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Legend Biotech is seeking a Program Lead, Cell and Gene Therapy as part of the Global Manufacturing and Supply team based in Raritan, NJ.

Role Overview

The program Lead will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role will lead strategic planning, drive execution, propose options to senior leadership, of the commercial manufacturing introduction activities across late-stage and commercial programs, ensuring technical excellence, regulatory readiness, operational execution, and seamless cross-functional alignment. The position requires close collaboration with cross-functional teams including R&D, process development, MSAT, global facility & engineering, Quality, procurement, regulatory affairs, and finance.

Key Responsibilities

Strategic Leadership

• Define and drive the internal commercial manufacturing strategy for iLVV.
• Evaluate internal/external options for iLVV commercial manufacturing, and seek stakeholder feedback.
• Present options and recommendations to senior leadership for decision-making.
• Provide clear, concise, and timely updates to senior management regarding program progress, risks, and strategic considerations.
• Motivate and inspire cross-functional teams, building momentum, alignment, and ownership.
• Make decisive, data-driven, and sometimes tough decisions to advance program objectives under aggressive timelines.

Planning & Execution:

• Develop detailed business and implementation plans and timeline for late stage clinical and commercial manufacturing to deliver launch milestones.
• Oversee facility fitness and readiness and ensure alignment with stakeholders on commercial tech transfer and production timelines.

Cross-Functional Collaboration

• Partner with R&D for process development and technology transfer.
• Work closely with engineering and Somerset facility teams for infrastructure planning.
• Drive decision-making that balances scientific rigor, speed, risk, and business impact.
• Coordinate with regulatory and quality teams to ensure compliance with global standards.
• Collaborate with finance to manage budgets and cost projections.

Process Development & Transfer

• Working with MSAT to drive commercial process transfer activities from development to manufacturing.
• Coordinate generation of process descriptions, control strategies, equipment requirements and Bill of Materials.
• Drive establishment of raw material requirements, QC method readiness and facility fit.
• Ensure robust scale-up and validation of vector manufacturing processes.

Manufacturing Site & Operational Readiness

• Ensure manufacturing facilities are prepared for the new product including capacity, equipment, utilities, and staffing.
• Partner with Supply Chain to secure long-lead materials, single-use components, and critical suppliers.
• Oversee line-of-business readiness: QA, QC, MSAT, warehouse, digital systems, labeling, analytics.
• Align on operational procedures (SOP updates, batch records, deviations/corrective actions).

Quality and Compliance

• Ensure compliance with applicable global GMP, ICH, and regulatory expectations.
• Support CMC submissions, PPQ documentation, change controls, and validation packages.
• Collaborate with Quality to ensure inspection readiness and audit support.

Continuous Improvement & Lifecycle Management

• Identify opportunities to optimize manufacturing robustness, cost, and yield post-launch.
• Implement lessons learned, knowledge management systems, and NPI best practices.
• Support product lifecycle changes such as process improvements, site expansions, and supply chain enhancements.

Requirements

Education

BS is required, Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field.

Experience

• Minimum 10+ years in biopharmaceutical manufacturing. Viral vector late processes development/manufacturing experience is required.
• Proven experience in facility scale and layout planning, and commercial process transfer and validation.
• Strong understanding of cGMP requirements and regulatory frameworks for cell and gene therapy products.

Skills

• Strategic thinking and ability to build consensus among peers and influence senior leadership.
• Excellent project management and cross-functional leadership skills.
• Strong communication and stakeholder management capabilities.
• Ability to thrive in a fast-paced, evolving environment.
• Highly goal-oriented, ownership-driven, and laser-focused on execution.
• Comfortable navigating ambiguity and making quick, high-impact decisions.

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Legend Biotech is seeking a Manager, Operations Training as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Manager, Operations Training, will be responsible for managing the training team who lead training activities for the overall plant operation team members who support cGMP Commercial Cell Therapy Manufacturing. This individual will oversee the Training team members in collaboration with department management in Operations and Quality to support personalized cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support the organization door to floor program and ramp-up of commercial production. The role will require technical experience, 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 a holistic, effective training program for all plant functions and personnel that support daily commercial production.
• Manages training team to plan, coordinate, prepare and deploy training curriculum.
• Perform training assessments for new and updated procedures.
• Oversee and schedule training skill checks and qualifications.
• Support evaluation of appropriate compliance courses.
• Leads and works with training team to manage training requirements for new hires.
• Work collaboratively with functional leads for procedure alignment based on roles.
• Serve as subject matter expert for Compliance & Training systems.
• Oversees onboarding for all new manufacturing operators.
• Knowledge of LMS system.
• Maintain and report quality training metrics.
• Prepares information for internal and external audits.
• Ensure productivity, timeliness, and quality of Change Controls and CAPA implementation.

Requirements

• A minimum of a Bachelor’s Degree in Science; advanced degree preferred.
• A minimum of 5-8 years relevant work and management experience is required. It is preferable that the candidate have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Must be 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 and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Works well in a team-oriented, collaborative environment.
• Demonstrated track record of driving continuous improvement initiatives.
• Proven leadership and team management skills.

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Legend Biotech is seeking a Facility Engineer as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for facilities engineering support, design, and implementation for mechanical systems and equipment, and work order management 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 the organization in maintaining commercial production at a state-of-the-art cell therapy facility. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Demonstrates professional execution of the planning, development, and implementation of construction and/or repair programs for engineering driven initiatives.
• Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and installations.
• Identifies, investigates, and analyzes a wide range of complex facilities, utilities, systems, equipment or manufacturing issues and develops a robust solution for remediation.
• Oversees, reviews, and approves the work of external engineering design and planning consultants; ensures that engineering designs are consistent with contract specifications and all relevant regulations and engineering standards.
• Supports the review of equipment, building, and other job plans within the CMMS for effectiveness, applicability, and compliance. Ensure all equipment is operated and maintained within a validated/qualified/certified state.
• Gathers and analyzes data, blueprints, and reports.
• Supports tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous improvement activities such as preventive maintenance optimization, risked based asset management programs, and analyze equipment for proper balance of preventive to corrective work order ratio.
• Supports maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
• Ensures regulatory and job training remains current by promptly completing required training.
• Complies with all company and/or site policies and procedures.
• Demonstrates willingness to learn new skills as required.
• Available for other duties as required.
• Ensures site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration.
• Ability to work independently and with minimal guidance/oversight.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. 

Requirements

• B.Sc./M Sc. in chemical, mechanical, electrical, industrial engineering or similar field is required
• Minimally 5+ years of experience as a facility engineer or working within an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions
• Experience with HVAC and building management systems is required
• Experience with SAP and MS Office is required
• Proficiency in English (verbal and written) and strong communication skills
• Experience with a CMMS or similar maintenance management system is preferred
• cGMP manufacturing familiarity is preferred
• Ability to apply engineering principles and techniques to the solution of equipment, buildings, and infrastructure.
• Construction/project management principles. 

Legend Biotech is seeking an Associate Manager, QA Shop Floor as part of the Quality team based in Raritan, NJ.

Monday - Friday / 2nd Shift

Role Overview

The Associate Manager, QA Shop Floor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.

Key Responsibilities

• Read, interpret, and revise documents such as SOPs, work instructions.
• Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
• Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
• Independently makes appropriate and compliant GMP decisions.
• Independently resolves problems using quality systems.
• Lead quality driven continuous improvement projects.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Support QASF team growth and development.
• Must be able to be Aseptic Gown Qualified.
• Possess the ability to positively influence peers, key stakeholders, and management.
• Generates shift schedules, to ensure efficient coverage for all operational needs.
• Maintain quality practices in accordance with state and federal regulatory requirements.
• Supports the completion of corrective and preventive actions, as necessary.
• Supports internal/external audits.
• Supports Quality risk assessment teams.
• Review/approve documents as a Quality on the Floor Subject Matter Expert (SME).
• Remain current in skills and industry trends.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.

Requirements

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Knowledge of CAR-T QC test methods and related equipment is preferred.
• Excellent written and oral communication skill are required.
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with regulatory inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.
• Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
• Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
• Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
• Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
• Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
• Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
• Employs good project management principles to appropriately align time, resources, and budgets.
• Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
• Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
• Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
• Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
• Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.
• Generates new solutions to problems by challenging the status quo and conventional thinking. 

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Legend Biotech is seeking a Junior Associate Facility Engineer as part of the Facilities & Engineering team based in Raritan, NJ.

Role Overview

The Associate Facility Engineer will support the operation, maintenance, and qualification of equipment and systems that enable a Cell Therapy manufacturing facility. This person will assist in equipment monitoring, documentation, and troubleshooting activities under the guidance of more senior engineers. The role requires technical curiosity, attention to detail, and the ability to work in a collaborative team environment. This individual will be part of the CAR-T Equipment team in support of clinical and commercial manufacturing as well as facility improvement initiatives.

Key Responsibilities

• Provide day-to-day technical support for equipment and process support installations. 
• Assist in maintaining reliability and compliance through preventive maintenance programs and equipment monitoring.
• Learn to recognize performance trends, document observations, and propose basic improvements that enhance reliability, safety, and quality.
• Support the development of maintenance and calibration records, work instructions, and SOPs within the Quality Management System.
• Participate in root cause investigations, CAPAs, and change controls by gathering data, preparing documentation, and collaborating with cross-functional teams including QA, Operations, and Validation.
• Work with technical equipment data and documentation to support analyses of the maintenance process and provide input to the Maintenance Manager.
• Help ensure that preventive maintenance and calibration activities are completed and recorded on time.
• Assist with equipment tracking, asset management system updates, and vendor communication under supervision.
• Contribute to improvement projects or new equipment introductions by supporting data collection, documentation, and basic technical evaluations.
• Interact with external service providers and support internal teams to ensure timely execution of service activities.
• Have the authority to make decisions related to technical direction, methodologies, approaches and product development processes. You can also make decisions related to project execution, including timelines, milestones and resource allocation approved by the engineering manager. Higher-level approvals are required for those related to significant batch impact, or elevated resource allocation as directed by engineering manager.

Requirements

• Bachelor’s Degree – Preferably in Engineering or Life Sciences.
• 0–2 years of experience in Facility, Engineering, or Operations (internship or co-op experience in a GMP setting preferred).
• Proficiency of Microsoft office.
• Experience with quality management systems.
• Maximo or SAP.

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Legend Biotech is seeking participants for Legend's Manufacturing Management, Leadership Development Program as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Legend’s U.S. manufacturing network supports clinical trials and commercial CAR-T therapies for patients across the United States, with CARVYKTI® available at more than 140 treatment centers nationwide. Through our collaboration with Johnson & Johnson, we continue to expand manufacturing capabilities across both regions to meet growing patient demand. top

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand

Key Responsibilities

• The Manufacturing Hi-Po Leadership Development Program at Legend Biotech is a 2.5–3 year leadership accelerator designed for high-potential Master’s graduates seeking to build careers at the intersection of advanced therapy manufacturing, operational strategy, and global supply.
• Participants will complete multiple-functional rotations (12 months each) within areas of Global Manufacturing; including Manufacturing Science & Technology (MSAT), Quality, Manufacturing, or Supply Chain over the course of the program. Rotations are tailored based on individual development goals, business needs, and participant interests, allowing candidates to gain targeted experience across key operational functions.
• This structured program integrates high-impact operations experiences, executive mentorship, and a Leadership Development Series focused on developing leaders at every level — from leading self and others to influencing senior stakeholders and driving enterprise-wide business outcomes.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• Recent M.S or M.A Graduate (Class of 2023-2026)
• 2-3 years of professional experience in life sciences, manufacturing, engineering, or supply chain environments
• Strong analytical, problem-solving, and cross-functional collaboration skills.
• Demonstrated leadership potential and aspiration to grow into future operational and enterprise leadership roles.
• Degree in Biomedical Engineering, Supply Chain/Manufacturing, or related discipline.

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Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. 

Role Overview

The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Schedule: Wed-Sat, 1^st Shift

Key Responsibilities  

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review of all documentation, in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs)
• Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
• Support batch review & material release in SAP for In-house reagents.
• Support Floor Spot-check, audit trail review.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
• Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
• Utilize multiple electronic quality systems, batch records and SAP.
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
• Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
• Provide QA shop floor support for extended periods of time.
• Responsibilities will include but not limited to tasks mentioned above.
• Support regulatory inspections and audits as needed.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Other duties will be assigned, as the need arises.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses
• Color Perception both eyes 5 slides out of 8.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning

Requirements

• Bachelors degree required in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
  
• Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
• Experience with quality support in clinical manufacture is preferred.
  
• Flexible to work on weekends, as needed.
  
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
  
• Is frequently required to communicate with coworkers.
  
• While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
  
• Ability to lift 20 lbs.
  
• Report to work on-time.
  
• Duties are required to be performed on-site at manufacturing facility.
  
• Perform other duties as assigned.
  
• Attend departmental and other scheduled meetings.
  
• Practice good interpersonal and communication skills.
  
• Demonstrate positive team-oriented approach in the daily execution of procedures.
  
• Promote and work within a team environment.
  
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  
• Support and contributes to projects.
  
• Assist in troubleshooting issues related to manufacturing.
  
• Technical knowledge within functional units
  
• Demonstrate an understanding of the process in order to properly perform the assigned tasks.
  
• Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
  
• Utilizes tools within MS Office and other systems to improve business effectiveness.
  
• Read and interpret documents such as safety rules, operating instructions, and logbooks.
  
• Review and provide feedback for SOPs.
  
• Interpret a variety of instructions furnished in written, oral, or diagram.
  
• Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
  
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals,
  
• Aseptic processing in ISO 5 clean room and biosafety cabinets.
  
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  
• Great attention to detail and ability to follow the procedures.
  
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a must.
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
  
• Ability to collaborate well with stakeholders, customers and peers.
  
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
  
• Ability to manage conflict and issues that arise with internal or external customers.

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Legend Biotech is seeking a QA Investigations Lead II/III as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates the quality mindset to strive for excellence, continuous improvement and ethical conduct in attaining and maintaining the highest levels of quality.

Key Responsibilities

• Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).
• Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented.
• Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.
• Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed.
• Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
• Collaborate with site personnel to provide guidance and determine resolution for end-to-end manufacturing issues.
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
• Perform analysis on quality indicating data and identifying trends.
• Contribute to maintain investigation compliance metrics.
• Support investigation process improvement initiatives.
• Job duties performed may require exposure to and handling of biological materials and hazardous chemicals
• Able to work independently and also in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 2-4 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products
• Great attention to detail and ability to follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Excellent organizational skills with the ability to simplify and clearly communicate complex concepts.
• Excellent verbal, written and presentation capabilities.
• Ability to summarize and present results, and experience with team-based collaborations is a must.
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
• Must exhibit strong leadership skills and effectively develop others.
• Ability to collaborate well with stakeholders, customers and peers.
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Must be able to discern the criticality of issues and communicate to management regarding complex issues.
• Ability to manage conflict and issues that arise with internal or external customers.

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Legend Biotech is seeking a  QC Microbiology Lead as part of the Quality team based in Raritan, NJ.

Role Overview

The QC Microbiology Lead is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff,
reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.

Key Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
• Raw material, in-process, environmental/utility, and product release testing.
• Scheduling of daily activities for personnel.
• Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
• Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
• People management or leadership experience is required.
• Experience working with Quality systems is required.
• Experience with quality support in clinical manufacture or NPI is preferred .
• Extensive knowledge of chemical, biochemical and microbiological concepts is required .
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• Good written and verbal communication skills are required.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• This position may require 10% domestic or international travel as business demands.

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Legend Biotech is seeking a Supervisor, QC Investigations as part of the Quality team based in Raritan, NJ.

Role Overview

The Supervisor, QC Micro is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.

Key Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
• Raw material, in-process, environmental/utility, and product release testing.
• Scheduling of daily activities for personnel.
• Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.
• other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
• Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
• People management or leadership experience is required.
• Experience working with Quality systems is required.
• Experience with quality support in clinical manufacture or NPI is preferred.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• Good written and verbal communication skills are required.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

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

Role Overview

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Shift Options Available:

• Wed–Sat, 2nd Shift

Key Responsibilities

• Lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
• Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
• Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• 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. 

Requirements

• Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
• A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Availability to work in a day shift (1st or 2nd shift) is required.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
• Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be 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 and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records
• A working leader who can participate in production runs in critical situations when needed.
• Ability to lift a minimum of 25 lbs. and stand for a long period of time. 

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Legend Biotech is seeking QC Analyst II as part of the Quality team based in Raritan, NJ.

Role Overview

The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities

• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Perform peer review/approval of laboratory data.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
• Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
• Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals. 

Requirements

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Knowledge of CAR-T QC test methods and related equipment is preferred.
• Excellent written and oral communication skill are required.
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with regulatory inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.
• Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
• Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
• Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
• Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
• Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
• Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
• Employs good project management principles to appropriately align time, resources, and budgets.
• Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
• Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
• Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
• Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
• Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.
• Generates new solutions to problems by challenging the status quo and conventional thinking. 

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Legend Biotech is seeking a Continuous Improvement Facilitator as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position provides operational excellence support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.

The Continuous Improvement Facilitator will lead and support a broad range of continuous improvement initiatives for CAR-T Manufacturing, ensuring alignment with site objectives and operational priorities. This role focuses on identifying improvement opportunities, implementing structured problem-solving methodologies, and driving sustainable operational improvements.

The role will require strong facilitation and communication skills to support the deployment of continuous improvement programs. The facilitator will collaborate across cross-functional teams to strengthen a problem-solving culture which supports the timely production, testing, and release of life-saving therapies to patients.

Key Responsibilities

• Support the planning, development, and execution of a continuous improvement initiatives using Lean and Six Sigma manufacturing methodologies, such as standardized work, PDCA, metrics, visual tools, 5S/6S, FMEA, Pareto analysis, and others to improve safety, compliance, cost, process stability, and efficiency.
• Design and implement data collection systems to support operational performance monitoring and continuous improvement initiatives, leveraging tools such as Power BI and Power Automate to automate workflows, visualize key metrics, and enhance data-driven decision-making.
• Facilitate and lead Kaizen events and improvement workshops aimed at improving process performance, reducing waste, driving right-first-time execution, and increasing operational productivity.
• Lead and support value stream mapping exercises, identify bottlenecks and inefficiencies, and collaborate with teams to develop improvement plans to streamline operations.
• Deliver training to team members across different functions in Lean tools, techniques, and methodologies, fostering a culture of problem-solving and continuous improvement at all levels of the organization.
• Support the implementation of key CI projects, assisting with tracking progress, managing resources, and reporting on the outcomes.
• Track and measure the impact of CI initiatives through relevant metrics and KPIs, providing regular updates to leadership on progress and areas of focus for continued improvement.
• Apply and coach change management principles within Operations to support the successful adoption and sustainment of improvements.
• Partner with Operational Excellence and Project Management Office to implement improvements across the organization.

Requirements

• BS/BA required in technical discipline: Engineering, science or similar field
• Lean Six Sigma Green preferred.
• GMP Manufacturing, Quality, Supply Chain experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Minimum of 2 years of experience leading and/or supporting continuous improvement, operational excellence, or process improvement within a manufacturing or regulated environment (e.g., cGMP)
• Knowledge of Lean and/or Six Sigma methodologies and their practical application to improve processes in operational environments such as Manufacturing, Quality, or Supply Chain.
• Experience facilitating Kaizen events and value stream mapping exercises.
• Strong understanding and proven application of problem-solving tools and techniques.
• Ability to engage all levels of the organization, from site leadership to the shop floor.
• Proven experience working and leading in a matrix environment.
• Excellent communication, interpersonal, and team-building skills, with the ability to influence and engage individuals at all levels of the organization.
• 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.
• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
• Proficiency in MS Teams, PowerBI, PowerAutomate preferred.
• 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.
• Solution-oriented mentality, capable of developing new procedures and alternate paths to overcome identified opportunities for improvement.

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Legend Biotech is seeking a Sr. QC Analyst as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities

• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Perform peer review/approval of laboratory data.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
• Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals. 

Requirements

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Knowledge of CAR-T QC test methods and related equipment is preferred.
• Excellent written and oral communication skill are required.
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with regulatory inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.
• Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
• Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
• Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
• Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
• Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
• Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
• Employs good project management principles to appropriately align time, resources, and budgets.
• Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
• Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
• Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
• Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
• Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.
• Generates new solutions to problems by challenging the status quo and conventional thinking. 

#Li-RP1

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Legend Biotech is seeking a Manufacturing Engineer, Technical Support as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Manufacturing Engineer, Tech Support will be part of the Technical Support team and be responsible to support the development and routine operation of a new CAR-T manufacturing process. They will be a subject matter expert for the manufacturing process and equipment primarily responsible for providing front line support to address and resolve manufacturing issues.

Key Responsibilities

• Partner closely with Quality, Compliance, and technical experts to drive accelerated, robust, and consistent resolution and escalation of process issues as applicable while ensuring batch quality and adherence to procedures and instructions.
• Support compliant manufacturing investigations and CAPAs, as subject matter experts.
• Review batch records updates to ensure alignment with the manufacturing process.
• Be a point of contact with equipment suppliers for timely and continuous support.
• Support the monitoring of the manufacturing process and process execution to identify and support opportunities for improvement and waste reduction.
• Represent the technical support team when interfacing with other departments.
• Perform regular manufacturing operations to collect process health data for the identification of process improvement and waste reduction opportunities.
• 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.
• Will be able to make most troubleshooting suggestions, and will work with partners in operations in quality to reach final decisions. For troubleshooting that leads to high process impact, an associate engineer will escalate to our senior team members. Manufacturing engineers will act independently as subject matter experts, especially when working with the Legend investigations team. Manufacturing engineers will independently make procedural updates and perform continuous improvement work.

Requirements

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 3-5 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Fundamental proficiency with the Microsoft office suite.
• Familiarity with Power Apps, Power BI, and Tableau preferred.

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Legend Biotech is seeking a Sr. Manager, QC Microbiology as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities

Key Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of people leaders and associates within the department.
• Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.
• Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Monitor QC method performance through trending analysis for on QC generated test results.
• Represent department during internal and external audits.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor’s Degree in Science, Biology or equivalent technical discipline is required.
• A Minimum of 12 to 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in microbiology quality control laboratory, quality assurance, or cell therapy. A minimum of 3-5 years of leadership experience is also required.
• Experience working with Quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Comfortable with speaking and interacting with inspectors.
• Good written and verbal communication skills are required.
• This position may require up to 10% domestic or international travel as business demands.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Proven people management and leadership experience are required.
• In-depth knowledge and experience in biopharmaceutical analysis method verification is preferred.
• Experience in microbiological test methods and EM is preferred.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying excellence tools and methodologies.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience in developing and setting long-term objectives for individual and teams.
• Have a high sense of responsibility and professionalism with excellent organizational skills, analytical judgment and communication skills.
• Able to work cross functionally and under pressure.

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

Role Overview

The Sr. Manager, Warehouse Operations will work within Technical Operations and be responsible for the ongoing site ramp-up, daily operational management, as well as continuous improvement of cGMP Warehouse Operations within a state-of-the-art cell therapy manufacturing facility. This individual will partner Technical Operations with other functions to support the production and distribution of cell therapy products through safe and compliant operations according to cGMP requirements.

Key Responsibilities

• Lead, direct, coach, and develop an effective Warehouse Operations team responsible for all inbound, outbound, material receipt & inventory management, and distribution processes for raw materials and final drug products.
• Establish a strong relationship between the different teams of the department by identifying clear roles and responsibilities.
• As a management member of the Warehouse team, participate in governances structure design, decision-making process, as well as performance management and initiatives related to the continuous improvement of the warehouse operations.
• Responsible for hiring, development, and performance management of staff (including shift teams) within the warehouse as well as the establishment of key performance indicators for Warehouse Operations.
• Responsible for management of warehouse budget inclusive but not limited to headcount, materials, consumables, services, out of pocket (OOP).
• Serve as BPO of the S4 HANA EWM environment to represent the Warehouse & Operations business requirements and accuracy of inventory, processes and document track. Support implementation of improvement projects to the EWM environment.
• Support the treatment and on time closure of deviations, Quality investigations and CAPA’s related to operational activities. Ensure good CAPA effectiveness checks to keep standards on day-to-day activities and avoid recurrences.
• Take accountability for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS, security requirements. Develop solutions to enhance quality, efficiency, capacity, safety and security.
• Participate in or coordinate projects that involve operations (e.g. material flow, people flow, continuous improvement)
• Interact with key site stakeholders, including but not limited to internal (Planning, Quality, Operations, Vein to Vein, Finance) and external (J&J, Avantor) to the department, on activities linked to his/her area of responsibilities. Be part of EHS improvement and culture change inside the teams. Participate to risk assessments within the Warehouse. Ensure safety observations identified on operational activities are addressed and support implementation of improvements.

Requirements

• Minimum: Bachelor’s degree in Supply Chain, Logistics or related equivalent field experience required. Masters degree desired.
• A minimum of 8-10 years relevant Supply Chain or equivalent experience is required.
• Experience in Pharma or Biologics manufacturing / Supply Chain is highly preferred.
• SAP and EWM experience is preferred • APICS certification is desirable and a strong plus.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Strength in communicating and working effectively with broad stakeholders in various scientific/technical/business disciplines.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Very strong influencing capabilities with an ability to interact and communicate effectively at all levels of the organization and across different functions.
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.
• Advanced knowledge of warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment.
• Advanced proficiency in the use of ERP systems, Warehouse Management Systems, and analytics Ability to promote a mindset of continuous improvement, problem solving, and prevention.

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

Role Overview

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Shift Options Available:

• Sun–Wed, 2nd Shift
• Wed–Sat, 2nd Shift

Key Responsibilities

• Lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
• Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
• Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• 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. 

Requirements

• Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
• A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Availability to work in a day shift (1st or 2nd shift) is required.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
• Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be 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 and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records
• A working leader who can participate in production runs in critical situations when needed.
• Ability to lift a minimum of 25 lbs. and stand for a long period of time. 

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Legend Biotech is seeking a Sr. QA Validation Specialist, CSV & Equipment as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. QA Validation Specialist, CSV & Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity.

Key Responsibilities

• Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site
• Review and approve qualification/validation documentation (specifications, protocols, reports).
• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration).
• Provide expertise and solutions to issues regarding qualification and validation strategies and documentation.
• Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems.
• Assist in the development of validation and qualification related policies, procedures, templates, forms.
• Provides quality oversight on data integrity of systems, instruments, and equipment used at the site.
• Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.
• Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site.
• Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Drive continuous improvement.
• Provide training and guidance to other members of the team.
• Other duties may be assigned, as necessary. 

Requirements

• A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required.
• 7+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus.
• Strong knowledge of GxP compliance.
• Experience in cGMP regulatory body audits.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information.
• Ability to work independently and be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow procedures closely.
• Ability to identify and assess possible gaps and work collaboratively to address such issues.
• Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Experience reviewing/auditing GMP documentation.
• Strong proficiency with using Microsoft Office applications. 

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

Role Overview

This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.

Key Responsibilities

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Train and support the junior team members on different CQV activities.
• Present CQV work to regulatory and internal audit teams.
• Other responsibilities as assigned.
• Making decision on corrective action in deviation events.
• Make decisions on technical approach, methodology per applicable procedure.
• Manager approval required for resource assignment, timeline shift, strategic shift and finance related events. 

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 7 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Ability to use following or similar systems for business needs: Microsoft suite & ERP systems: Maximo, Siemens EMS, Comet, Kneat & Testing system: Kaye AVS, Kaye Valprobe.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols. 

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