Legend Biotech US
Overview
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech is seeking a
QA Shop Floor Specialist II/III
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. 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, and 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. 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 as assigned; tasks may include exposure to biological materials and hazardous chemicals. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Read and interpret documents such as safety rules, operating instructions, and logbooks; good written and verbal communication skills required. Demonstrate an understanding of the process to properly perform assigned tasks; strong proficiency with SAP, electronic batch records (EBR), and quality systems. Ability to summarize and present results; experience with team-based collaborations; ability to determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate with stakeholders, customers and peers; maintain strong decision-making and problem-solving skills under minimal supervision. Ability to manage conflict and issues that arise with internal or external customers. Requirements
Bachelor’s degree in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience. 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. Must be mobile and able to independently transport between sites/locations as required. Ability to communicate with coworkers; physically capable of standing, walking, bending, reaching; lift up to 20 lbs. On-site manufacturing facility work required; punctual and reliable attendance. Willingness to perform other duties as assigned and attend departmental meetings. Strong interpersonal and communication skills; capable of working in a team environment; willingness to learn new skills and procedures. Experience with SAP, electronic batch records (EBR), and quality systems; proficiency with MS Office tools. Ability to interpret and apply safety rules, operating instructions, and logbooks; knowledge of cGMP regulations and FDA/EU guidance related to cell-based products; Good Tissue Practices knowledge preferred. Ability to think critically, troubleshoot issues, and communicate complex issues to management; ability to influence quality and compliance without direct authority. Compensation and Benefits
The anticipated base pay range is: $75,972 - $99,713 USD Legend Biotech is committed to creating a workplace where employees can thrive. We offer a best-in-class benefits package including medical, dental, and vision insurance; 401(k) with company match; equity and stock options for eligible roles; paid parental leave; and a comprehensive paid time off policy. Other benefits include flexible spending and health savings accounts, life and AD&D insurance, disability coverage, and additional programs and resources to support well-being and career growth. EEO Statement
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace. Apply for this job
*
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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech is seeking a
QA Shop Floor Specialist II/III
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. 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, and 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. 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 as assigned; tasks may include exposure to biological materials and hazardous chemicals. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Read and interpret documents such as safety rules, operating instructions, and logbooks; good written and verbal communication skills required. Demonstrate an understanding of the process to properly perform assigned tasks; strong proficiency with SAP, electronic batch records (EBR), and quality systems. Ability to summarize and present results; experience with team-based collaborations; ability to determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate with stakeholders, customers and peers; maintain strong decision-making and problem-solving skills under minimal supervision. Ability to manage conflict and issues that arise with internal or external customers. Requirements
Bachelor’s degree in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience. 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. Must be mobile and able to independently transport between sites/locations as required. Ability to communicate with coworkers; physically capable of standing, walking, bending, reaching; lift up to 20 lbs. On-site manufacturing facility work required; punctual and reliable attendance. Willingness to perform other duties as assigned and attend departmental meetings. Strong interpersonal and communication skills; capable of working in a team environment; willingness to learn new skills and procedures. Experience with SAP, electronic batch records (EBR), and quality systems; proficiency with MS Office tools. Ability to interpret and apply safety rules, operating instructions, and logbooks; knowledge of cGMP regulations and FDA/EU guidance related to cell-based products; Good Tissue Practices knowledge preferred. Ability to think critically, troubleshoot issues, and communicate complex issues to management; ability to influence quality and compliance without direct authority. Compensation and Benefits
The anticipated base pay range is: $75,972 - $99,713 USD Legend Biotech is committed to creating a workplace where employees can thrive. We offer a best-in-class benefits package including medical, dental, and vision insurance; 401(k) with company match; equity and stock options for eligible roles; paid parental leave; and a comprehensive paid time off policy. Other benefits include flexible spending and health savings accounts, life and AD&D insurance, disability coverage, and additional programs and resources to support well-being and career growth. EEO Statement
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace. Apply for this job
*
#J-18808-Ljbffr