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, 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 Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Role Overview

The Investigation Associate will be part of the MS&T team and has the mission to: 

  • Own the investigation process and methodologies, create awareness and educate the organization on the importance of and how to adequately and efficiently handle quality investigations.
  • Lead multiple department manufacturing investigations as appropriate and/or establish strategy to quickly driving to root cause to meet critical release windows (the highest priority being safe and timely product release for the patient).
  • Oversee processes and standards and support the implementation of CAPAs related to the manufacturing process together with MS&T process expert, process engineer and knowledge management.
  • Act as the company support for Regulatory Authorities inspection of investigational Manufacturing Science and Technology subjects, accountable to defend the strategy, investigation reporting and potential answer to observation.
  • Build solid and long-lasting connections with different stakeholders in order to ensure smooth alignment and handling of complex investigations, while acting as the shopfloor single point of contact.
  • Contribute to the strategic plan by building up scientific and cGMP specialist capability/expertise (SME) of cell and gene therapy processes and/or process technologies to thrive improvement of Product Quality, Safety and Efficacy.
Major Responsibilities:
  • Process Robustness:
    • Own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving.
    • Provide support and technical expertise to the Technical Operations team in support of ongoing technical transfer (incl. process validation – continuous process verification) and manufacturing operations.
    • Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
    • Recognize the need for, develop/design and implement job aids, templates and processes, focusing on quality investigations to build an efficient and standardized investigation system.
  • Quality & Compliance:
    • Apply and implement appropriate risk assessment methodologies and root cause analysis tools and assess product quality impact.
    • Act as the company support for Regulatory Authorities inspection of investigational Manufacturing Science and Technology subject, accountable to defend the strategy, investigation reporting and potential answer to observation.
    • Stay up to date with regulatory requirements and state of the art guidelines, maintain permanent inspection readiness, actively support regulatory inspections and preparation thereof as SME, and support the implementation of actions resulting from such inspections.
    • Draft, feed, review/revise, and/or support writing of (not limited to):
      • Investigations (incl. impact and risk assessments, corrections, CAPAs)
      • Change controls
      • Development reports
      • Qualification and validation protocols and reports
      • Technical assessments and rationales
      • SOPs and work instructions
      • Batch records
      • Continuously maintain compliance with internal training requirements
    • Recognize and act on potential compliance issues and opportunities for process changes/improvement.
  • Continuous Improvement:
    • Support the implementation of quality investigation resulting CAPAs related to the manufacturing process.
    • To further maintain and lead the investigation dashboard and supporting QEM systems and identify opportunities for improvement.
    • Ensure connection between recurrent deviations and process robustness activities, perform trending and feed the organization based on lessons learned from investigations.
    • Contribute to technical feasibility studies related to process improvement and implementation of new manufacturing and automation technologies.
    • Provide technical expertise and perform technical feasibility studies to support the implementation of process improvements, new manufacturing technologies and automation, that would provide reduction in COGs, increase throughput, capacity and quality compliance. 
  •  Development/Role Specific:
    •  Build strong partnerships in a matrixed environment, i.a. by liaising with different internal cross functional teams such as Manufacturing (Operations), QC (IPL) Supply Chain, Engineering and  Quality, as well as effectively integrating with external collaborators, to drive projects/programs 
      forward and ensure efficient execution of process validation and production schedules (clinical and commercial).
    • Ensure seamless flow of knowledge and information across functions, departments, and with other sites when applicable, resulting in fast and effective resolution of issues.
    • Self-develop by actively seeking and following training courses and conferences, with focus on extending product and process knowledge, as well as supporting investigations. Also further codevelop the MS&T team and entire organization by sharing intelligence.
    • Act as delegate for Investigator Lead responsibilities upon request.
    • Participation of key/industry leading conferences, job days and other opportunities to promote the organization and CAR-T technology



A minimum of a Master’s degree in Engineering, Science, Pharmacy or related field or 
equivalent experience required


Minimum 2-3 years of operations experience within a cGMP environment (manufacturing/quality/development) in the biotech/biopharma industry and preferably cell/gene therapy.

Capabilities, Knowledge, and skills:

  • Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
  • Ability to work independently and successfully under minimal supervision and integrate cross-functional issues and balance competing priorities effectively.
  • Born team player.
  • Excellent scientific writing
  • Being able to manage shifting priorities and multiple tasks simultaneously to meet critical deadlines in a fast paced and dynamic, growing environment.
  • Positive and pro-active attitude.
  • Results driven while working within GMP framework of procedures and rules.
  • Excellent organizational skills.
  • Strong analytical mind, problem solving and critical thinking skills. Being able to trouble shoot and resolve complex scientific/technical problems.
  • Advanced computer skills and practical knowledge.
  • Clear communicator with ability to build strong partnerships.
  • Accurate, Authentic, Transparent, Passionate, Fearless and Accountable


Fluent Dutch and English 


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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