Operations Process Trainer, Aseptic Process

Company: Legend Biotech
Location: Raritan
Posted on: January 20, 2026

Job Description:

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 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 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. Li-DD1 Li-Onsite 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 vacation days, personal days, sick time, 11 company 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. Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. 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.

Keywords: Legend Biotech, Freeport , Operations Process Trainer, Aseptic Process, Healthcare , Raritan, New York