Legend Biotech · 2 months ago
Operations Process Trainer, Aseptic Process
Raritan, New Jersey, United States
Full-time
Onsite
Mid Level
$76K/yr - $100K/yr
4+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases, headquartered in Somerset, New Jersey. They are seeking an Operations Process Trainer for the Technical Operations team in Raritan, NJ, responsible for performing process training activities for Operations team members in cGMP Clinical and Commercial Cell Therapy Manufacturing.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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
Qualification
Required
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
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options are available to employees in eligible roles
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2026-01-17
2025-12-18
Company data provided by crunchbase