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Operations Gowning Associate

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 a Operations Gowning Associate as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

This position is responsible for performing manufacturing gowning training and the execution of gowning training tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities  

  • Be part of the manufacturing operations team responsible for production of autologous CAR-T productsSupport the Gowning Training Program responsible for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment..
  • Execute Instructor Led Trainings (ILT), Qualifications, and Requalification of Raritan CAR-T Personnel.
  • Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
  • Execute manufacturing gowning activities to supportcommon to cell culturing, purification, aseptic processing, and cryopreservation using appropriate gowning techniques.
  • Perform process unit operations according to gowning training and execution that follows standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
  • Perform tasks on time in a manner consistent with quality systems, and cGMP, and Learning Management System (LMS) requirements.
  • Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
  • Aid in the development of manufacturing gowning processes including appropriate documentation.
  • Drive continuous improvement of gowning techniques and processesmanufacturing operations leveraging own observation as well as input of team members.
  • Handle human derived materials in containment areas.
  • Support schedule adjustments to meet production and business needs.
  • Accurately complete documentation in SOP’s, logbooks, and other GMP documents, and training events.
  • Demonstrate training progression through assigned curriculum.
  • Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
  • Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
  • Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
  • Ensure materials are available for production qualifications and training.
  • Support the ongoing production schedule by:
    • Report to work on-time and according to the shift schedule.
    • 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.
    • Support investigation efforts as required.
    • Responsible for audit preparation and participation.

Requirements

  • HS Diploma required with 4-6 Years Biotech/Pharmaceutical experience or equivalent industry experience 

OR

  • Bachelor's degree required in Life Sciences or Engineering, with 0-2 years Biotech/Pharmaceutical experience or equivalent industry experience
  • Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Follow instructions
  • 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.
  • Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
  • Knowledge of Process Excellence Tools
  • Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
  • 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 25 lbs.
  • Needs to perform gowning procedures to work in manufacturing core.

 

#DD1

#Onsite

The anticipated base pay range is:

$57,445 - $75,396 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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