Operations Process Trainer

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 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.

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

Role Overview

The Operations Process Trainer will be responsible for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with Training team members in collaboration with management in Operations 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.

1st Shift, Mon-Fri

Key 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 strategically prepares for 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

* Serve as subject matter expert for Compliance & Training systems

* Knowledge of LMS system

* Supports the maintenance and reporting of quality training metrics

* Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

* Job duties include operating an industrial vehicle;
Ability to lift a minimum of 50 lbs and stand for a long period of time

* Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.

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. 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…