Description

Legend Biotech is seeking QC Technical Trainer III as part of the Quality team based in Raritan, NJ.

Role Overview

The QC Technical Trainer is an exempt level position working within QC Microbiology training team. This individual will be responsible for performing training activities for Quality Control Microbiology team members who support cGMP Clinical and Commercial Cell Therapy testing. This role will require technical experience, effective communication, coordination, and collaboration across relevant cross functional groups to enable robust testing and release of products to patients. This position is primarily a M-F schedule, with potential nights or weekends temporary coverage as needed.

Key Responsibilities

• Lead, coach, and deliver trainings for the Quality Control Microbiology team and Operations team (as needed).
• Be responsible for conducting training and qualifying QC Microbiology Specialists on QC test methods.
• Work closely with QC Onboarding Associate(s)/QC Leads/Supervisors to ensure planned training events were completed as scheduled and provide feedback as needed.
• Conducts Observation, Side-by-Side, and Instructor Led Training inside of laboratory and CAR-T cGMP Manufacturing facility.
• Conducts knowledge and skill check and independent performance qualifications for Quality Control Microbiology inside of laboratory and CAR-T cGMP Manufacturing facility.
• Ensure testing and training is completed in compliance with all applicable procedures, standards and GMP regulations.
• Support day to day Quality Control Microbiology activities as needed.
• Perform peer review/ approval of laboratory data as needed.
• Helps write or revise SOPs, Work Instructions, Job Aids, knowledge, and skills assessments.
• Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel.
• Work cross functionally with the training team to ensure the development/ qualification processes.
• Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution.
• Provide awareness trainings to the Quality Control Microbiology team.
• Performs trainings within CAR-T manufacturing facility inside of cleanroom environments.
• Serve as subject matter expert for Learning Management Systems.
• Support the maintenance and reporting of quality training metrics.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• A Minimum of 0-2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with biosafety cabinets is required.
• Candidate must have experience working within an aseptic manufacturing facility, preferably within quality control, quality assurance, training/systems applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practices is required.
• Experience with training methodology, adult learning theory, and train-the-trainer programs.
• Curriculum and module design experience.
• Detailed knowledge of CAR-T QC test methods and related equipment is required
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate occasional weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights
  and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.

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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.

Benefits

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company 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 full-time 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.

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