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Validation Lifecycle & Technical Lead

Raritan, New Jersey, United States

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 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 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.

 

Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. 

Role Overview

This position represents a critical support role in the global MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both within Legend but also externally with our program partner Janssen. This effort will extend to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the commercial governance structure. The candidate will also be required to collaboratively work within identified sub-teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a multi-site global manufacturing network responsible for manufacturing an approved cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working on Quality related sub-teams such as change control sub-teams and investigational sub-teams.  The material/ raw material scope includes working both internally and with external partners to track changes to our material/ raw material program and develop best practices for evaluation of changes to the same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template efforts worldwide as part of collaborative working groups and cross functional partners.

Key Responsibilities  

  • Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material sub-teams to support global best practices
  • Partner closely with Legend and Janssen partners to complete supporting technical documentation with an eye for global alignment templates
  • Work collaboratively with internal and external partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycle
  • Align global documentation strategy
  • Provide input and review for validation documents including master plans, PPQ and comparability protocols and reports
  • Serve as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limits
  • Develop and align a variety of process validation documentation templates ranging from control strategies to PVP and PPQ templates
  • Support global initiatives related to quality/compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program)
  • Contribute to developing and/or improvements to quality systems in support of global implementation of changes (e.g., process and material changes

Requirements

  • B.S. required.
  • Minimum 5 years of industrial biologics experience, CAR-T experience is highly desirable.
  • Candidate must have experience in Cell Therapy, MSAT and/or Quality/Compliance (particularly in material/ raw material enrollment and release).
  • Experience in a cross functional commercial team in driving global programs and/or initiatives.
  • Experience in developing, writing and approving technical documents.
  • Experience with Quality systems (Change control, investigations, LIMs, etc.).
  • Extensive technical writing experience.
  • Knowledge in cell therapy validation industry best practices is highly preferred.
  • Ability to think critically and demonstrated troubleshooting and problem-solving skills.
  • Results driven with strong analytical, problem solving and critical thinking skills.
  • Experience working in a cross-functional organization with multiple partners with competing priorities.

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Benefits

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 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 - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

 

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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