QC Training Specialist and Coordinator

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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.

Role Overview:

The QC Training Coordinator is a position with training coordination and training responsibilities within QC area, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Major Responsibilities:

The QC Training Coordinator has both training coordination and training responsibilities, as the need arises.

Training coordination responsibilities

• Develops and oversees the planning of the execution, documentation and review of QC IPL and EM trainings in order to meet the qualification needs within the CAR-T QC laboratories in Ghent and to meet the needs for QC-support for manufacturing operations.
• Closely works together with the QC Supervisors to find solutions to urgent or unplanned training-related problems and sets up a system of standard work for trainings.
• Keeps close connection with the training department and the QC trainers of the release labs.
• Closely works together with Supervision, Scheduler and Manufacturing Operations to define the timing of (re)qualifications for visual inspection.
• Executes training related projects (in collaboration with other QC functions) according to project timelines and resource and materials availability. Presents and reports project deliverables to peers and relevant stakeholders.
• Acts as the point of contact for the organization of QC trainings in external labs.
• Supports in the set-up of individual training profiles in Summit for the different function within the QC-teams in Ghent and in the maintenance and reporting of quality training metrics.
• Performs training assessments for new and updated procedures.
• Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for the QC teams in Ghent.
• Serves as subject matter expert for QC training systems.
  
  

Training responsibilities:

• Responsible for the completion of QC training related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Performs trainings related to the QC-methods such as but not limited to GMP, GDP, environmental monitoring, elims, visual inspection, …
• Conducts Observation, Side-by-Side and Instructor Led training
• Ensures training is completed in compliance with all applicable procedures, standards and GMP regulations.
• Prepares and maintains training materials and equipment in the Ghent CAR-T QC laboratories.
• Performs peer review/approval of laboratory data including but not limited to training formbooks and records.
• Creates, revises and reviews relevant QC documents, SOP’s and WI’s.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  
  

The QC Training Coordinator is available for other duties and demonstrates willingness to learn new skills as required.

Qualifications

Education:

• Bachelor’s or master’s degree in science, Bio-Engineering, Pharmacy, Biotechnology, FBLT, MLT or any other related field or equivalent experience required.
  
  

Experience:

• A Minimum of 4 years of relevant experience in a laboratory function within an industrial manufacturing or regulated environment. Experience in a QC lab in a controlled pharmaceutical environment is preferred.
  
  

Key Capabilities, Knowledge, and Skills:

• A passion to make the difference in the life of patients.
• Proven training capabilities.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of pharmaceutical products is required.
• Detailed knowledge of CAR-T QC test methods and related equipment is a plus.
• Knowledge about elims is a plus.
• The candidate must be highly organized, responsible and capable of working in a highly regulated environment with a positive attitude under limited supervision.
• Excellent interpersonal and written/oral communication skills, teamwork oriented. Must exhibit ability to convey information to more junior people within the team in a structured and clear way.
• Ability to interact with external stakeholders related to training and to build strong partnerships with other departments.
• Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs is a plus.
• Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to QC supervisors, QC schedulers, QC analysts and QC support technicians.
• Ability to pay attention to details and follow procedures.
• Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint).
• Fluent in both 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.