Operations Process Trainer

Legend Biotech Corp • Raritan, NJ

59d • Onsite

About The Position

Legend Biotech is seeking Operations Process Trainer 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. Schedule: Mon-Fri, 2nd Shift

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

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 1,001-5,000 employees