Legend Biotech
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 entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview Legend Biotech is seeking a
QA Shop Floor Specialist II/III
as part of the
Quality Operations
team based in
Raritan, New Jersey .
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, miscellaneous runs 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 required (5/8 correct).
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
Qualifications
Bachelors degree required 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.
Strong communication and teamwork skills; ability to document and summarize results and present to stakeholders.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products and Good Tissue Practices.
Proficiency with SAP, electronic batch records (EBR), and quality systems; strong MS Office skills.
Ability to interpret documents, follow SOPs, and work under minimal supervision in a fast-paced environment.
Aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Ability to lift up to 20 lbs and perform on-site duties as required.
Compensation and Benefits The anticipated base pay range is: $75,972 USD - $99,713 USD
Benefits:
We are committed to creating a workplace where employees can thrive—professionally and personally. Our benefits include medical, dental, and vision insurance, a 401(k) plan with company match, and additional programs. Details are provided in the benefits section of our posting.
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.
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Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview Legend Biotech is seeking a
QA Shop Floor Specialist II/III
as part of the
Quality Operations
team based in
Raritan, New Jersey .
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, miscellaneous runs 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 required (5/8 correct).
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
Qualifications
Bachelors degree required 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.
Strong communication and teamwork skills; ability to document and summarize results and present to stakeholders.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products and Good Tissue Practices.
Proficiency with SAP, electronic batch records (EBR), and quality systems; strong MS Office skills.
Ability to interpret documents, follow SOPs, and work under minimal supervision in a fast-paced environment.
Aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Ability to lift up to 20 lbs and perform on-site duties as required.
Compensation and Benefits The anticipated base pay range is: $75,972 USD - $99,713 USD
Benefits:
We are committed to creating a workplace where employees can thrive—professionally and personally. Our benefits include medical, dental, and vision insurance, a 401(k) plan with company match, and additional programs. Details are provided in the benefits section of our posting.
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.
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