Legend Biotech Us
Overview
To be considered for an interview, please make sure your application is full in line with the job specs as found below. 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 CAR-T, TCR-T, and NK cell-based immunotherapies. 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 with Janssen to jointly develop and commercialize 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 Legend Biotech is seeking a
Quality Systems Lead
as part of the
Quality
team based in
Raritan, NJ .
Key Responsibilities
Provide oversight to the CAPA program for the CAR-T manufacturing site.
Oversee metrics, trending, and reporting of relevant quality systems records.
Support CAPA site governance program.
Drive continuous improvement of quality systems processes.
Ensure compliance with current Good Manufacturing Practices (cGMP).
Manage multiple and complex cross-functional projects with many stakeholders.
Support other quality systems activities, as needed.
Support drafting, review and approval of standard operating procedures and any other required documentation.
Collaborate with functional departments to resolve issues.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Require minimal direction to complete tasks, know how to get resources and information from established internal contacts, and consult with supervisor for decisions outside established processes.
Requirements
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline or relevant experience is required.
A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
Strong written and verbal communication, analytical problem solving and conflict resolution skills.
Flexible, highly motivated, with strong organization skills, ability to multitask with attention to detail.
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
Flexibility in work schedule is required.
Effective interpersonal skills with the ability to communicate across all levels of the organization.
Ability to work independently with a high degree of accountability.
Ability to quickly process complex information.
Proficient in applying process excellence tools and methodologies.
Ability to independently be responsible for a portfolio of ongoing projects.
Ability to work with and lead others in a team environment.
Experience developing and setting long-term objectives.
Ability to identify/remediate gaps in processes.
Operational experience with electronic quality systems is required.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Compensation The anticipated base pay range is:
$107,482 - $141,070 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. Benefits include medical, dental, and vision insurance; a 401(k) plan with company match; equity and stock options in eligible roles; paid parental leave; and a comprehensive paid time off policy. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, disability coverage, and other voluntary plans. 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, 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.
#J-18808-Ljbffr
To be considered for an interview, please make sure your application is full in line with the job specs as found below. 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 CAR-T, TCR-T, and NK cell-based immunotherapies. 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 with Janssen to jointly develop and commercialize 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 Legend Biotech is seeking a
Quality Systems Lead
as part of the
Quality
team based in
Raritan, NJ .
Key Responsibilities
Provide oversight to the CAPA program for the CAR-T manufacturing site.
Oversee metrics, trending, and reporting of relevant quality systems records.
Support CAPA site governance program.
Drive continuous improvement of quality systems processes.
Ensure compliance with current Good Manufacturing Practices (cGMP).
Manage multiple and complex cross-functional projects with many stakeholders.
Support other quality systems activities, as needed.
Support drafting, review and approval of standard operating procedures and any other required documentation.
Collaborate with functional departments to resolve issues.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Require minimal direction to complete tasks, know how to get resources and information from established internal contacts, and consult with supervisor for decisions outside established processes.
Requirements
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline or relevant experience is required.
A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
Strong written and verbal communication, analytical problem solving and conflict resolution skills.
Flexible, highly motivated, with strong organization skills, ability to multitask with attention to detail.
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
Flexibility in work schedule is required.
Effective interpersonal skills with the ability to communicate across all levels of the organization.
Ability to work independently with a high degree of accountability.
Ability to quickly process complex information.
Proficient in applying process excellence tools and methodologies.
Ability to independently be responsible for a portfolio of ongoing projects.
Ability to work with and lead others in a team environment.
Experience developing and setting long-term objectives.
Ability to identify/remediate gaps in processes.
Operational experience with electronic quality systems is required.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Compensation The anticipated base pay range is:
$107,482 - $141,070 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. Benefits include medical, dental, and vision insurance; a 401(k) plan with company match; equity and stock options in eligible roles; paid parental leave; and a comprehensive paid time off policy. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, disability coverage, and other voluntary plans. 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, 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.
#J-18808-Ljbffr