Training Specialist

**Company Information**

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.

**Position Overview**

The position will be responsible for performing training activities for employees which support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with Training team members in collaboration with management in different divisions 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 aseptic handling experience, technical experience, effective communication, training skills, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

**Major Responsibilities**
- Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, Supply Chain) that supports daily clinical production and commercial supply of a CAR-T product
- Manages, plans, coordinates, prepares and performs hands-on training curriculum in areas of general use, foundational and core skills, systems, unit operations and aseptic processing
- Prepares and maintains training lab, materials and equipment
- Conducts Observation, Side-by-Side, and Instructor Led Training
- Conducts knowledge and skill checks and independent performance qualifications for Operations
- Helps write or revise SOPs/Work Instructions, knowledge and skills assessments
- Performs training assessments for new and updated procedures
- Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for Operations
- Supports evaluation of appropriate compliance courses for Operations
- Performs training for new hires
- Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel
- Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution
- Supports the maintenance and reporting of quality training metrics

**Education**:
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.

**Experience**:
A minimum of 5-10 years relevant work experience is required.

Fluency in Dutch is a requirement

**Capabilities, Knowledge, and skills**:

- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue PracticesKnowledge and experience on aseptic processing
- Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs
- Curriculum and module design experience
- Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems
- Good verbal and written communication skills
- Excellent organizational skills
- Ability to effectively prioritize and execute tasks in a fast-paced environment
- Works well in a team-oriented, collaborative environment
- Proactive and continuous improvement oriented****:

- Ability to lead with influence
- cGMP manufacturing
- 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 management
- Change management
- Transparent, Passionate, Fearless and Accountable
- Fluent in both Dutch and English
- Knowledge of LMS system

LI-AG1

Legend Biotech maintains a drug-free workplace.