BioSpace
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 ciltacabtagene autolecuel (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 CQV Specialist II
as part of the
Technical Operations
team based in
Raritan, NJ .
This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The individual will handle day‑to‑day activities including execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The role requires CQV and engineering experience, ability to work independently, and to drive effective communication, coordination and collaboration across cross‑functional groups to establish a strong, compliant CQV program that enables robust production, testing and release of product to patients.
Key Responsibilities
Execute the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
Manage multiple and complex CQV projects, provide status reports and coordinate with other departments or outside contractors/vendors to complete tasks.
Support and/or own technical and quality investigations, CAPAs and corrections.
Develop and perform required remediation efforts and associated CAPA plans.
Author, own and execute master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
Execute, own, assess and participate in the creation, revision and review of change controls, SOPs, and other documentation.
Participate in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans and Annual Product Reviews.
Work collaboratively with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain and Planning teams.
Requirements
Minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
Minimum of 4 years relevant work experience, preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance or manufacturing compliance.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and make critical decisions with limited information.
Proficiency in applying process excellence tools and methodologies.
Ability to independently manage a portfolio of ongoing projects.
Attention to detail and adherence to procedures.
Highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills.
Experience summarizing and presenting results; team‑based collaboration experience is required.
Detailed knowledge of cGMP and cGTP related to CAR‑T manufacturing or cell processing.
Ability to identify and remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required; 600, 601 and 610 preferred.
Experience authoring and executing documentation including Batch Records, SOPs, Work Instructions, CQV protocols.
Experience with TrackWise, CMMS and Maximo.
Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).
Language: English.
Anticipated base pay range: $81,273 – $106,669 USD.
Benefits 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 vesting 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 (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 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 ciltacabtagene autolecuel (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 CQV Specialist II
as part of the
Technical Operations
team based in
Raritan, NJ .
This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The individual will handle day‑to‑day activities including execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The role requires CQV and engineering experience, ability to work independently, and to drive effective communication, coordination and collaboration across cross‑functional groups to establish a strong, compliant CQV program that enables robust production, testing and release of product to patients.
Key Responsibilities
Execute the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
Manage multiple and complex CQV projects, provide status reports and coordinate with other departments or outside contractors/vendors to complete tasks.
Support and/or own technical and quality investigations, CAPAs and corrections.
Develop and perform required remediation efforts and associated CAPA plans.
Author, own and execute master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
Execute, own, assess and participate in the creation, revision and review of change controls, SOPs, and other documentation.
Participate in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans and Annual Product Reviews.
Work collaboratively with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain and Planning teams.
Requirements
Minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
Minimum of 4 years relevant work experience, preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance or manufacturing compliance.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and make critical decisions with limited information.
Proficiency in applying process excellence tools and methodologies.
Ability to independently manage a portfolio of ongoing projects.
Attention to detail and adherence to procedures.
Highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills.
Experience summarizing and presenting results; team‑based collaboration experience is required.
Detailed knowledge of cGMP and cGTP related to CAR‑T manufacturing or cell processing.
Ability to identify and remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required; 600, 601 and 610 preferred.
Experience authoring and executing documentation including Batch Records, SOPs, Work Instructions, CQV protocols.
Experience with TrackWise, CMMS and Maximo.
Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).
Language: English.
Anticipated base pay range: $81,273 – $106,669 USD.
Benefits 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 vesting 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 (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 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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