Legend Biotech
Legion 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 commercialise
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.
Position: Specialist, QA Process Excellence Location: Raritan, NJ
Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. The role also provides oversight of technical operations activities, including data or document review, risk assessments, CAPAs, and continuous improvement activities. The Specialist serves as a subject‑matter expert for the manufacturing process and provides quality oversight for technical teams.
Key Responsibilities
Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities.
Provide guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations.
Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol‑driven activities such as tech transfer and process validation.
Assist in the development of process, operational, and quality improvements for manufacturing.
Assist in the review and development of process‑related protocols and documentation.
Provide technical quality oversight for electronic batch records.
Support manufacturing and technical operations teams in troubleshooting and resolving complex scientific / technical problems.
Evaluate quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations.
Provide Quality Oversight for batch records, change controls, SOPs, non‑conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.
Handle multiple priorities daily while remaining flexible and responsive to frequently shifting priorities.
Work independently to perform assigned tasks.
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
May support CSV activities as needed.
May support equipment qualification activities as needed.
Requirements
Minimum of a Bachelor’s Degree in Science or equivalent technical discipline.
5+ years relevant work experience or equivalent. Preferably experience working in an aseptic manufacturing facility within quality assurance, manufacturing compliance, clinical quality, or cell therapy; a portion of the 5 years must include quality assurance experience.
Strong knowledge of cell therapy processes strongly preferred.
Experience with Manufacturing Execution Systems (MES) design/development and validation preferred.
Experience with Computer System Validation (CSV) is a plus.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
Experience reviewing/auditing GMP documentation.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and make critical decisions with limited information.
Ability to work independently and to Escalate to management when required.
Detail‑oriented and able to follow procedures closely.
Ability to identify and assess possible gaps and to work collaboratively to address such issues.
Highly organized and capable of working in a team environment with a positive attitude.
Strong proficiency with Microsoft Office applications.
The anticipated base pay range is:
$75,972 USD - $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 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; paid time off: 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide 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, colour, 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.
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Quality Assurance
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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 commercialise
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.
Position: Specialist, QA Process Excellence Location: Raritan, NJ
Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. The role also provides oversight of technical operations activities, including data or document review, risk assessments, CAPAs, and continuous improvement activities. The Specialist serves as a subject‑matter expert for the manufacturing process and provides quality oversight for technical teams.
Key Responsibilities
Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities.
Provide guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations.
Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol‑driven activities such as tech transfer and process validation.
Assist in the development of process, operational, and quality improvements for manufacturing.
Assist in the review and development of process‑related protocols and documentation.
Provide technical quality oversight for electronic batch records.
Support manufacturing and technical operations teams in troubleshooting and resolving complex scientific / technical problems.
Evaluate quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations.
Provide Quality Oversight for batch records, change controls, SOPs, non‑conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.
Handle multiple priorities daily while remaining flexible and responsive to frequently shifting priorities.
Work independently to perform assigned tasks.
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
May support CSV activities as needed.
May support equipment qualification activities as needed.
Requirements
Minimum of a Bachelor’s Degree in Science or equivalent technical discipline.
5+ years relevant work experience or equivalent. Preferably experience working in an aseptic manufacturing facility within quality assurance, manufacturing compliance, clinical quality, or cell therapy; a portion of the 5 years must include quality assurance experience.
Strong knowledge of cell therapy processes strongly preferred.
Experience with Manufacturing Execution Systems (MES) design/development and validation preferred.
Experience with Computer System Validation (CSV) is a plus.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
Experience reviewing/auditing GMP documentation.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and make critical decisions with limited information.
Ability to work independently and to Escalate to management when required.
Detail‑oriented and able to follow procedures closely.
Ability to identify and assess possible gaps and to work collaboratively to address such issues.
Highly organized and capable of working in a team environment with a positive attitude.
Strong proficiency with Microsoft Office applications.
The anticipated base pay range is:
$75,972 USD - $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 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; paid time off: 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide 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, colour, 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.
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Quality Assurance
#J-18808-Ljbffr