Legend Biotech US
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 autologous and allogeneic CAR-T, TCR-T, and NK cell-based immunotherapy. From our R&D sites around the world, we pursue safe, efficacious, and cutting-edge therapeutics for patients worldwide.
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 ensures quality and maintains the highest standards in compliance with company policies, procedures, and all applicable regulations. Key Responsibilities
Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues. Real time review of all documentation and reporting in support of process unit operations, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs). Support aseptic process simulations to ensure sterility is not compromised. Support material release in SAP for in-house reagents. Strive to reduce non-conformances by proactively driving compliance. Support Investigations team by providing quality 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 meet business objectives. Must be able to aseptically gown / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Support regulatory inspections and audits as needed. Adhere to safety policies, quality systems, and cGMP requirements, and comply with state and federal regulations. Other duties may be assigned as needed. Duties may involve exposure to biological materials and hazardous chemicals. Demonstrate strong attention to detail, organization, and ability to work with minimal supervision in a team setting. Proficient in SAP, electronic batch records (EBR), and quality systems; able to summarize and present results and collaborate with stakeholders. Ability to interpret problems and determine appropriate resolutions to ensure compliance and minimize risk. Ability to manage conflicts and issues with internal or external customers. Must discern the criticality of issues and communicate complex matters to management. Requirements
Bachelor’s degree in Life Sciences or Engineering. 4+ years Biotech/Pharmaceutical experience or equivalent. 2 years of relevant quality experience in an aseptic manufacturing facility (QA, manufacturing compliance, clinical quality, technical operations, or cell therapy). Experience with quality support in clinical manufacture is preferred. Flexibility to work on weekends, as needed. Must be mobile and able to travel between sites as required. Excellent written and verbal communication skills; strong interpersonal abilities; team-oriented approach. Ability to operate in ISO 5 clean rooms and biosafety cabinets; aseptic processing experience. Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing and Good Tissue Practices. Proficiency with manufacturing applications (SAP), EBRs, and quality systems; strong MS Office skills. Ability to work on-site at the manufacturing facility; ability to stand, walk, bend, and lift up to 20 lbs as needed. Benefits and EEO
Legend Biotech is committed to creating a workplace where employees can thrive. We offer a comprehensive benefits package to support well-being, financial stability, and long-term career growth, including medical, dental, and vision insurance; a 401(k) plan with company match; equity and stock options for eligible roles; paid parental leave; paid time off; and additional voluntary benefits such as flexible spending accounts, life and disability coverage, and more. We also provide commuter benefits, well-being programs, and peer-to-peer recognition. EEO Statement Legend Biotech is an 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 Biotech maintains a drug-free workplace.
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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 ensures quality and maintains the highest standards in compliance with company policies, procedures, and all applicable regulations. Key Responsibilities
Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues. Real time review of all documentation and reporting in support of process unit operations, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs). Support aseptic process simulations to ensure sterility is not compromised. Support material release in SAP for in-house reagents. Strive to reduce non-conformances by proactively driving compliance. Support Investigations team by providing quality 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 meet business objectives. Must be able to aseptically gown / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Support regulatory inspections and audits as needed. Adhere to safety policies, quality systems, and cGMP requirements, and comply with state and federal regulations. Other duties may be assigned as needed. Duties may involve exposure to biological materials and hazardous chemicals. Demonstrate strong attention to detail, organization, and ability to work with minimal supervision in a team setting. Proficient in SAP, electronic batch records (EBR), and quality systems; able to summarize and present results and collaborate with stakeholders. Ability to interpret problems and determine appropriate resolutions to ensure compliance and minimize risk. Ability to manage conflicts and issues with internal or external customers. Must discern the criticality of issues and communicate complex matters to management. Requirements
Bachelor’s degree in Life Sciences or Engineering. 4+ years Biotech/Pharmaceutical experience or equivalent. 2 years of relevant quality experience in an aseptic manufacturing facility (QA, manufacturing compliance, clinical quality, technical operations, or cell therapy). Experience with quality support in clinical manufacture is preferred. Flexibility to work on weekends, as needed. Must be mobile and able to travel between sites as required. Excellent written and verbal communication skills; strong interpersonal abilities; team-oriented approach. Ability to operate in ISO 5 clean rooms and biosafety cabinets; aseptic processing experience. Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing and Good Tissue Practices. Proficiency with manufacturing applications (SAP), EBRs, and quality systems; strong MS Office skills. Ability to work on-site at the manufacturing facility; ability to stand, walk, bend, and lift up to 20 lbs as needed. Benefits and EEO
Legend Biotech is committed to creating a workplace where employees can thrive. We offer a comprehensive benefits package to support well-being, financial stability, and long-term career growth, including medical, dental, and vision insurance; a 401(k) plan with company match; equity and stock options for eligible roles; paid parental leave; paid time off; and additional voluntary benefits such as flexible spending accounts, life and disability coverage, and more. We also provide commuter benefits, well-being programs, and peer-to-peer recognition. EEO Statement Legend Biotech is an 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 Biotech maintains a drug-free workplace.
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