Legend Biotech
CQV Specialist II
Legend Biotech is a global biotechnology company dedicated to treating and ultimately curing life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of platforms, including autologous and allogenic CAR‑T, TCR‑T, and NK cell‑based immunotherapies.
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel) for multiple myeloma.
Role Overview This position will provide Commissioning, Qualification, and Validation support to the cGMP clinical and commercial cell‑therapy manufacturing plant. The role involves day‑to‑day execution, protocol management, vendor management, handling deviations, corrections, and remediation efforts for facility, equipment, systems, and processes, ensuring safe and compliant manufacturing operations per cGMP requirements. The candidate will work independently and coordinate across cross‑functional teams to establish a robust CQV program that enables production, testing, and release of product for patients.
Key Responsibilities
Execute commissioning, qualification, requalification, validation, and associated maintenance activities within the plant.
Manage multiple and complex CQV projects, provide status reports, and coordinate with departments or external contractors/vendors.
Support and/or own technical and quality investigations, CAPAs and corrections.
Develop and perform 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.
Collaborate with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain and Planning.
Requirements
A bachelor’s degree in science, engineering or a related technical discipline.
Minimum four years of relevant experience, preferably in an aseptic manufacturing facility, cell‑therapy, testing facility, QA or manufacturing compliance.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, and Good Tissue Practices.
Strong interpersonal and written or oral communication skills.
Ability to process complex information, make critical decisions with limited information, and apply process‑excellence tools and methodologies.
Ability to independently manage a portfolio of ongoing projects and pay close attention to detail.
Experience authoring and executing documentation including Batch Records, SOPs, Work Instructions, CQV protocols.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 (and preferably 600, 601, 610).
Experience with TrackWise, CMMS and Maximo.
Proficient with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
English language proficiency.
The anticipated base pay range is $81,273 USD to $106,669 USD.
Benefits
Medical, dental and vision insurance.
401(k) retirement plan with company match that vests fully on day one.
Equity and stock options available to 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 and 3 floating holidays.
Flexible spending and health savings accounts.
Life and AD&D insurance.
Short‑term and long‑term disability coverage.
Legal assistance and supplemental plans such as pet, critical illness, accident and hospital indemnity insurance.
Commuter benefits.
Family planning and care resources, well‑being initiatives, 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. Legend’s policy ensures 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.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Other
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Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel) for multiple myeloma.
Role Overview This position will provide Commissioning, Qualification, and Validation support to the cGMP clinical and commercial cell‑therapy manufacturing plant. The role involves day‑to‑day execution, protocol management, vendor management, handling deviations, corrections, and remediation efforts for facility, equipment, systems, and processes, ensuring safe and compliant manufacturing operations per cGMP requirements. The candidate will work independently and coordinate across cross‑functional teams to establish a robust CQV program that enables production, testing, and release of product for patients.
Key Responsibilities
Execute commissioning, qualification, requalification, validation, and associated maintenance activities within the plant.
Manage multiple and complex CQV projects, provide status reports, and coordinate with departments or external contractors/vendors.
Support and/or own technical and quality investigations, CAPAs and corrections.
Develop and perform 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.
Collaborate with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain and Planning.
Requirements
A bachelor’s degree in science, engineering or a related technical discipline.
Minimum four years of relevant experience, preferably in an aseptic manufacturing facility, cell‑therapy, testing facility, QA or manufacturing compliance.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, and Good Tissue Practices.
Strong interpersonal and written or oral communication skills.
Ability to process complex information, make critical decisions with limited information, and apply process‑excellence tools and methodologies.
Ability to independently manage a portfolio of ongoing projects and pay close attention to detail.
Experience authoring and executing documentation including Batch Records, SOPs, Work Instructions, CQV protocols.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 (and preferably 600, 601, 610).
Experience with TrackWise, CMMS and Maximo.
Proficient with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
English language proficiency.
The anticipated base pay range is $81,273 USD to $106,669 USD.
Benefits
Medical, dental and vision insurance.
401(k) retirement plan with company match that vests fully on day one.
Equity and stock options available to 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 and 3 floating holidays.
Flexible spending and health savings accounts.
Life and AD&D insurance.
Short‑term and long‑term disability coverage.
Legal assistance and supplemental plans such as pet, critical illness, accident and hospital indemnity insurance.
Commuter benefits.
Family planning and care resources, well‑being initiatives, 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. Legend’s policy ensures 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.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Other
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