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QC Analyst II

Raritan, New Jersey, United States

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 QC Analyst II as part of the Quality team based in Raritan, NJ. 

Role Overview

 The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities  

  • Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP clean room environment.
  • Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
  • Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
  • Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
  • Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.
  • Create, review and approve relevant QC documents, SOP’s and WI’s.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Job duties performed routinely require exposure to and handling of biological materials andhazardous chemicals
  • Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visualacuity corrected to 20/30 (Snellen) or better with corrective lenses.
  • Color Perception both eyes 5 slides out of 8Qualifications

Requirements

  • Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
  • Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required
  • Experience in a Quality Control setting is preferred
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required
  • Knowledge of Good Tissue Practices is required.
  • Detailed knowledge of CAR-T QC test methods and related equipment is preferred
  • Excellent written and oral communication skill are required
  • Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
  • Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Comfortable with speaking and interacting with inspectors.
  • This position may require occasional travel to partner sites in NJ or PA as business demands.
  • This position may require up to 10% domestic or international travel as business demands.
    • Ownership and Commitment:
    • Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
    • Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
    • Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
    • Agility and Prioritization:
    • Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
    • Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
    • Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
    • Employs good project management principles to appropriately align time, resources, and budgets.
    • Teamwork and Communication:
    • Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
    • Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
    • Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
    • Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
    • Continuous Improvement:
    • Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change
    • Generates new solutions to problems by challenging the status quo and conventional thinking.

#Li-Onsite

#Li-DD1

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 law.

Legend Biotech maintains a drug-free workplace.

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