Operations Process Trainer, Aseptic Process

Overview

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, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize 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.

Legend Biotech is seeking Operations Process Trainer, Aseptic Process as part of the Technical Operations team based in Raritan, NJ
.

Operations Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will work within an Operations Unit and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust training, regulatory compliance, team readiness, and processing of product prior to release to patients.

• Leads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically prepare for commercial supply of a CAR-T product
• Manages, plans, coordinates, prepares and performs hands-on process training curriculum for specific unit operation qualification.
• Prepares and maintains training lab, materials, and equipment.
• Conducts Observation, Side-by-Side, and Process Qualification activities for new trainees.
• Assess technical qualifications of new Operations trainees.
• Conducts knowledge and skill checks for Operations.
• Work with Operations Management to assess and report on new trainee development.
• Work with Operations Management to develop streamlined and robust qualification process.
• Helps write or revise Operations training procedures, practices, 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.
• 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.
• Knowledge of LMS system.
• Supports the maintenance and reporting of quality training metrics.
• Support daily manufacturing activities when necessary.

• A minimum of a Bachelor’s Degree in a Life Sciences field or equivalent technical discipline/experience is required.
• A minimum of 4 years relevant work experience is required. Candidate must have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management 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, 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.
• 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.

The Anticipated Base Pay Range Is: $75,972 - $99,713 USD
.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual…