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.

#Li-RP1

#Li-Onsite

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.

#Li-RP1

#Li-Onsite

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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#Li-Onsite

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. 

#Li-RP1

#Li-Onsite

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.

#LI-BG1

#LI-Onsite

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.

#Li-RP1

#Li-Onsite

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

#Li-Onsite

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. 

#Li-RP1

#Li-Onsite

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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