BioSpace
QA Shop Floor Specialist III – 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, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize cilta‑cel (ciltacabtagene autolecuel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Position: QA Shop Floor Specialist III (Quality Operations) – Raritan, New Jersey.
Role Overview The QA Shop Floor Specialist is an exempt level position responsible for floor quality oversight of the production of autologous CAR‑T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. The position ensures quality and maintains the highest standards in compliance within company policies, procedures, and all applicable regulations.
Schedule: Sun‑Wed 1st 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 and internal audits.
Collaborate with site personnel to provide guidance and determine the immediate path forward for manufacturing quality issues.
Review documentation in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs).
Support processes, including aseptic process simulations, commercial and clinical manufacturing, and miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
Support batch review and material release in SAP for in‑house reagents.
Support floor spot‑check and audit trail review.
Proactively drive compliance to reduce non‑conformances in supported areas.
Support the Investigations team with quality and compliance input for continuous improvement and remediation.
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.
Aseptically gown to support Grade B Clean rooms and practice aseptic behavior in controlled areas.
Provide QA shop floor support for extended periods.
Support regulatory inspections and audits as needed.
Adhere to safety policies, quality systems, and cGMP requirements and state/federal regulations.
Other duties as assigned; job duties require exposure to biological materials and hazardous chemicals.
Must meet visual acuity and color perception requirements.
Work collaboratively with quality counterparts across departments.
Requirements
Bachelor’s degree required in Life Sciences or Engineering.
0‑2+ years of 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.
Mobile and able to transport between sites as required.
Frequent communication with coworkers.
Regularly required to stand, walk, climb, bend, stoop, and reach with hands and arms.
Ability to lift 20 lbs.
Report to work on time.
Perform other duties as assigned; attend scheduled meetings.
Good interpersonal and communication skills.
Positive team‑oriented approach and desire to learn new skills.
Support and contribute to projects; troubleshoot issues related to manufacturing.
Technical knowledge within functional units; understand processes to properly perform assigned tasks.
Proficient with SAP, electronic batch records (EBR), and quality systems.
Utilize MS Office and other systems to improve business effectiveness.
Read and interpret safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret instructions in written, oral, or diagram form.
Deal with complexity across drug product, manufacturing process, and end‑to‑end supply chain.
Solve practical problems with limited standardization.
Perform basic arithmetic calculations.
Aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Knowledge of cGMP regulations and FDA/EU guidance on cell‑based product manufacturing and Good Tissue Practices.
Great attention to detail and ability to follow procedures.
Highly organized and capable of working under minimal supervision.
Good written and verbal communication; summarize and present results.
Strong decision‑making; think creatively while maintaining compliance and quality.
Communicate effectively to management regarding complex issues.
Manage conflict and issues with internal or external customers.
Compensation Base pay range: $75,972 – $99,713 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; paid time off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer recognition programs.
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, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize cilta‑cel (ciltacabtagene autolecuel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Position: QA Shop Floor Specialist III (Quality Operations) – Raritan, New Jersey.
Role Overview The QA Shop Floor Specialist is an exempt level position responsible for floor quality oversight of the production of autologous CAR‑T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. The position ensures quality and maintains the highest standards in compliance within company policies, procedures, and all applicable regulations.
Schedule: Sun‑Wed 1st 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 and internal audits.
Collaborate with site personnel to provide guidance and determine the immediate path forward for manufacturing quality issues.
Review documentation in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs).
Support processes, including aseptic process simulations, commercial and clinical manufacturing, and miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
Support batch review and material release in SAP for in‑house reagents.
Support floor spot‑check and audit trail review.
Proactively drive compliance to reduce non‑conformances in supported areas.
Support the Investigations team with quality and compliance input for continuous improvement and remediation.
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.
Aseptically gown to support Grade B Clean rooms and practice aseptic behavior in controlled areas.
Provide QA shop floor support for extended periods.
Support regulatory inspections and audits as needed.
Adhere to safety policies, quality systems, and cGMP requirements and state/federal regulations.
Other duties as assigned; job duties require exposure to biological materials and hazardous chemicals.
Must meet visual acuity and color perception requirements.
Work collaboratively with quality counterparts across departments.
Requirements
Bachelor’s degree required in Life Sciences or Engineering.
0‑2+ years of 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.
Mobile and able to transport between sites as required.
Frequent communication with coworkers.
Regularly required to stand, walk, climb, bend, stoop, and reach with hands and arms.
Ability to lift 20 lbs.
Report to work on time.
Perform other duties as assigned; attend scheduled meetings.
Good interpersonal and communication skills.
Positive team‑oriented approach and desire to learn new skills.
Support and contribute to projects; troubleshoot issues related to manufacturing.
Technical knowledge within functional units; understand processes to properly perform assigned tasks.
Proficient with SAP, electronic batch records (EBR), and quality systems.
Utilize MS Office and other systems to improve business effectiveness.
Read and interpret safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret instructions in written, oral, or diagram form.
Deal with complexity across drug product, manufacturing process, and end‑to‑end supply chain.
Solve practical problems with limited standardization.
Perform basic arithmetic calculations.
Aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Knowledge of cGMP regulations and FDA/EU guidance on cell‑based product manufacturing and Good Tissue Practices.
Great attention to detail and ability to follow procedures.
Highly organized and capable of working under minimal supervision.
Good written and verbal communication; summarize and present results.
Strong decision‑making; think creatively while maintaining compliance and quality.
Communicate effectively to management regarding complex issues.
Manage conflict and issues with internal or external customers.
Compensation Base pay range: $75,972 – $99,713 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; paid time off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer recognition programs.
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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