Operations Process Trainer, Aseptic Process

Operations Process Trainer, Aseptic Process

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

Role Overview

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.

Key Responsibilities

• 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 streamlines 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.

Requirements

The anticipated base pay range is $75,972 - $99,713 USD

Benefits

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

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 applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.