Cell Therapy Training Lead

Legend Biotech

Cell Therapy Training Lead

Legend Biotech

Ghent, Belgium

About the job

Legend Biotech is recruiting a Cell Therapy Training Lead for the CAR-T European Manufacturing Hub in Ghent.

Legend Biotech is establishing two state of the art CAR-T manufacturing centers in Ghent (Belgium) together with our collaboration partner Janssen Pharmaceutica.

CAR-T (chimeric antigen receptor T cell therapy) is an innovative approach to treat blood cancer by harnessing the patients own immune system. The therapy is created from the patients own T cells which are engineered to eliminate cancer cells.

Company Introduction

From the very beginning, we've been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients’ bear and the difficulties they face, which drove us to think about what's next.

We believe it's time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we're using that hope to ignite the future of CAR-T cell therapy.

Strategic Collaboration

Legend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Role Overview

The Training Lead is responsible for developing the Training Strategy and overseeing training activities for the facility team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing.

This individual will partner with other functions to develop the required capabilities to support personalized cell therapy production through safe and compliant operations according to cGMP requirements.

This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production.

The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Major Responsibilities

  • Leads the development and deployment of an effective training program/academy for all plant functions and personnel that support daily clinical production and strategically prepares for commercial supply of a CAR-T product;
  • Leads, directs and coaches a team of operational trainers in the execution and follow up of the training programs;
  • Determines and manages training requirements for new hires and all user groups. Manages the onboarding and qualification of new hires within the manufacturing hub;
  • Oversees and schedules training skill checks and qualifications for all staff and functions. Performs training assessments for new and updated procedures;
  • Works collaboratively with functional leads for procedure alignment and determining training needs based on roles and functional objectives;
  • Supports plant team in support of the Cornerstone on Demand (CSOD) learning management system (LMS);
  • Maintains and reports quality training metrics and work collaboratively with all functions to develop strong professional skills and capabilities across the organisation;
  • Prepares information and supports internal and external regulatory inspections.

Key Relationships

Ability to interact with all levels within the organization - Operations, Quality, HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering, Validation.

Requirements

  • A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required;
  • A minimum of 4 years relevant work experience is required with compliance training experience in the pharmaceutical industry. A minimum of 3 years of Learning Management Systems (LMS) experience. It is preferable that the candidate have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems;
  • In depth knowledge of cGMP regulations related to aseptic manufacturing of cell based products;
  • Good verbal and written communication skills combined with excellent organizational skills;
  • Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels;
  • The candidate must be highly organized and capable of leading and working in a team environment with a positive attitude under minimal supervision;
  • Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members;
  • Strong analytical, problem solving and critical thinking skills;
  • Project and Change management;
  • Transparent, Passionate, Fearless and Accountable;
  • Fluent in Dutch.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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