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 a Training Specialist, Aseptic Operations as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Training Specialist, Aseptic Operations will be responsible for the scheduling and coordination of training and aseptic process qualification (APQ) program for Raritan CAR-T Manufacturing team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with Operations management in collaboration with Quality Assurance Microbiologists , to develop a comprehensive training journey for new aseptic operators. This role will require learning principles experience, effective communication, leadership, coordination and collaboration across relevant cross functional groups and stakeholders to enable robust APQ training program for advancement of Raritan CAR-T Operators.

Key Responsibilities

Leads and owns the Aseptic training, qualification, requalification schedule weekly.
Develops end-to-end aseptic training plans for new and current operators.
Assigns curricula to new and current aseptic operators according to learning journey as needed.
Maintains tracking and scheduling of yearly requalification’s.
Tracks progress of Aseptic Operators and ensures on time completion of training.
Track and maintains KPI’s that impact site production capacity.
Plan and meet site capacity goals by ensure the sufficient quality and quantity of aseptic operators.
Collaborates and stays connected with Operations and QA Micro.
Works on aseptic training improvement projects that make a positive impact on the APQ Program.
Collaborates with Process Engineering, Technical Support, Planning, and other advanced areas on implementation projects that may impact APQ program.
Identifies APQ needs and expectations, monitors progress, addresses and resolves gaps in training requirements for Operations and other support areas.
Elevated access level in LMS to capture training compliance in real-time, assign training as needed, and run reports.
Supports the maintenance and reporting of QA training metrics.

Requirements

A minimum of a Bachelor’s Degree in Science, Information Science or equivalent experience is required.
A minimum of 5 years relevant work experience is required.
Candidate must have experience working within an aseptic manufacturing facility, preferably in QA or QA Micro, training, project management, learning management systems, or quality systems.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Experience with training methodology, adult learning theory, scheduling, and training plans.
LMS experience

Capabilities, Knowledge, and skills:

Advanced computer skills and practical knowledge of MS Office Suite (advanced Excel experience preferred), 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.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
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.

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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.

Training Specialist

Aseptic Operations

Legend Biotech

Capabilities, Knowledge, and skills:

6 month growth

1 year growth

2 year growth

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