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Legend Biotech US

Technical Trainer

Legend Biotech US, Raritan, New Jersey, us, 08869

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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. Legend Biotech is seeking Technical Trainer

as part of the

Technical Operations

team based in

Raritan, NJ. Role Overview Technical Trainer will be responsible for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with Training team members in collaboration with management in Operations to support personalized cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients. Key Responsibilities Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, Supply Chain) that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product Manages, plans, coordinates, prepares and performs hands-on training curriculum in areas of general use, foundational and core skills, systems, unit operations and aseptic processing

Prepares and maintains training lab, materials and equipment

Conducts Observation, Side-by-Side, and Instructor Led Training Conducts knowledge and skill checks and independent performance qualifications for Operations

Helps write or revise SOPs/Work Instructions, knowledge 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

Performs training for new hires

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

Serve as subject matter expert for Compliance & Training systems Knowledge of LMS system

Supports the maintenance and reporting of quality training metrics

Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

Job duties include operating an industrial vehicle; Ability to lift a minimum of 50 lbs and stand for a long period of time

Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses. Requirements

A minimum of a Bachelors Degree in Science, Information Science or equivalent technical discipline 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 #Li-DD1 #Li-Onsite The anticipated base pay range is: $66,063 - $86,706 USD 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 Legends 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. Apply for this job

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(the Agreement) with Legend Biotech USA Inc.(the Company), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me. Access to Company Confidential Information.

I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below. I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a)not use or disclose any Confidential Information; (b)keep all Confidential Information confidential at all times; and (c)not copy, reproduce or modify any Confidential Information. Definition of Confidential Information.

For purposes of this Agreement, Confidential Information shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know-how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof;

provided, however,

that Confidential Information shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure. Third Party Information.

I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer. I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public. Remedies for Breach.

I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Companys right to obtain such relief shall not limit its right to obtain other available remedies. General.

The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California. This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company. Please print your name if you agree to the terms and conditions set forth in the applicant Non-Disclosure Agreement. *

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