Sr. CQV Specialist
Legend Biotech, Raritan, NJ, United States
Company Overview
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 worldwide, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.
Role Overview
This Sr. CQV Specialist will provide Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant in Raritan, NJ. The role requires day‑to‑day execution of protocol management, vendor management, issue resolution, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production. The specialist will represent CQV work in regulator and internal audits and independently drive effective communication and coordination across relevant cross‑functional groups to establish a strong, compliant CQV program enabling robust production, testing and release of product to patients.
Key Responsibilities
Execute commissioning, qualification, requalification, validation and associated maintenance activities within the plant.
Manage multiple and complex CQV projects, collaborating with cross‑functional teams, providing status reports and coordinating with other departments or external contractors/vendors to complete tasks.
Support 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.
Train and support junior team members on different CQV activities.
CQV work to regulatory and internal audit teams.
Make decisions on technical approach, methodology per applicable procedure.
Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.
Requirements
A minimum of a Bachelor’s Degree in science, engineering or equivalent technical discipline.
A minimum of 7 years relevant work experience. Preferred experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance or manufacturing compliance.
Proficiency with Microsoft suite and ERP systems (Maximo, Siemens EMS, Comet, Kneat) and testing systems (Kaye AVS, Kaye Valprobe).
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products and Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to process complex information quickly and make critical decisions with limited information.
Proficiency in applying process excellence tools and methodologies.
Independent management of a portfolio of ongoing projects.
High organization and team‑environment capacity with a positive attitude under some supervision.
Experience authoring and executing documentation including batch records, SOPs, work instructions and CQV protocols.
Compensation
Base pay range: $107,482 USD – $141,070 USD. Performance‑based bonus and/or equity is available to employees in eligible roles.
Benefits
Medical, dental, and vision insurance; 401(k) retirement plan with company match vesting fully on day one; eight weeks of paid parental leave after three months of employment; paid time‑off policy including vacation, personal, sick, floating holidays, and eleven company 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 provides equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
General
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.
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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 worldwide, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.
Role Overview
This Sr. CQV Specialist will provide Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant in Raritan, NJ. The role requires day‑to‑day execution of protocol management, vendor management, issue resolution, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production. The specialist will represent CQV work in regulator and internal audits and independently drive effective communication and coordination across relevant cross‑functional groups to establish a strong, compliant CQV program enabling robust production, testing and release of product to patients.
Key Responsibilities
Execute commissioning, qualification, requalification, validation and associated maintenance activities within the plant.
Manage multiple and complex CQV projects, collaborating with cross‑functional teams, providing status reports and coordinating with other departments or external contractors/vendors to complete tasks.
Support 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.
Train and support junior team members on different CQV activities.
CQV work to regulatory and internal audit teams.
Make decisions on technical approach, methodology per applicable procedure.
Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.
Requirements
A minimum of a Bachelor’s Degree in science, engineering or equivalent technical discipline.
A minimum of 7 years relevant work experience. Preferred experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance or manufacturing compliance.
Proficiency with Microsoft suite and ERP systems (Maximo, Siemens EMS, Comet, Kneat) and testing systems (Kaye AVS, Kaye Valprobe).
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products and Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to process complex information quickly and make critical decisions with limited information.
Proficiency in applying process excellence tools and methodologies.
Independent management of a portfolio of ongoing projects.
High organization and team‑environment capacity with a positive attitude under some supervision.
Experience authoring and executing documentation including batch records, SOPs, work instructions and CQV protocols.
Compensation
Base pay range: $107,482 USD – $141,070 USD. Performance‑based bonus and/or equity is available to employees in eligible roles.
Benefits
Medical, dental, and vision insurance; 401(k) retirement plan with company match vesting fully on day one; eight weeks of paid parental leave after three months of employment; paid time‑off policy including vacation, personal, sick, floating holidays, and eleven company 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 provides equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
General
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.
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