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QA Batch Disposition 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.

 

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Legend Biotech is seeking Title as part of the Department team based in Location. 

Role Overview

This exempt-level position is responsible for performing a wide range of activities to support the release of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities  

  • Lead the team responsible for QA oversight of final CAR-T product batch record review and release practices.
  • Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities, including manual and electronic practices.
  • Establish and implement cGMP procedures to ensure compliant practices from all employee participating in the release process.
  • Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
  • Support HR supervisory activities for designated team members.
  • Support Investigations team by providing quality and compliance input for continuous improvement; and remediations.
  • Lead quality driven continuous improvement projects to reduce turnaround time for batch review / release.
  • Require minimal direction to complete tasks, know how to attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.
  • Provide direction to the batch review/ release team to meet department and business goals.
  • Maintain Batch Status Spread Sheets up to date.
  • Collaborate with (cross)functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results to allow for timely release of final product batches according to department and business plan.
  • Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review/release process.
  • Contribute to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
  • Perform duties under limited supervision and according to standard operating and manufacturing procedures.
  • Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Maintain quality practices in accordance with state and federal regulatory requirements.
  • Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
  • Ensure readiness of records for regulatory inspections and internal audits.
  • Review, compile, and organize batch data.
  • Review, compile, batch documents for retention and archival.
  • Ability to utilize multiple electronic quality systems.

Requirements

  • Bachelor’s degree required in Life Sciences or Engineering, with 6+ years Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices
  • Great attention to detail and ability to follow the procedures.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  • Good written and verbal communication skills are required.
  • Ability to collaborate well with stakeholders, customers, and peers.
  • Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
  • Is frequently required to communicate with coworkers.
  • While performing the duties of this job, the employee is regularly required to stand, walk; climb, bend, and stoop; and reach with hands and arms.
  • Ability to lift 20 lbs.
  • Report on working on time and according to the company policy.
  • Perform other duties as assigned.
  • Attend departmental and other scheduled meetings.
  • Practice good interpersonal and communication skills.
  • Demonstrate positive team-oriented approach in the daily execution of procedures.
  • Promote and work within a team environment.
  • Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  • Strong proficiency utilizing electronic Quality Systems per curriculum.
  • Utilizes tools within MS Office and other systems to improve business effectiveness.
  • Support and contribute to projects.
  • Assist in troubleshooting issues related to manufacturing and batch release.
  • Interpret a variety of instructions furnished in written, oral, or diagram.
  • Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
  • Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.
  • Read and interpret documents such as safety rules, operating instructions and logbooks.
  • Review and provide feedback for SOPs

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The anticipated base pay range is:

$93,463 - $122,670 USD

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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  5. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California.  This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

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