Description

<div class="content-intro">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&amp;D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. &nbsp; Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson &amp; 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. &nbsp;</div>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&nbsp;individual will be responsible for performing training activities for Quality Control Microbiology team members&nbsp;who support cGMP Clinical and Commercial Cell Therapy testing. This role will require technical experience,&nbsp;effective communication, coordination, and collaboration across relevant cross functional groups to enable&nbsp;robust testing and release of products to patients. This position is primarily a M-F schedule, with potential&nbsp;nights or weekends temporary coverage as needed. Key Responsibilities <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Lead, coach, and deliver trainings for the Quality Control Microbiology team and&nbsp;Operations team (as needed).</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Be responsible for conducting training and qualifying QC Microbiology Specialists on QC test methods.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work closely with QC Onboarding Associate(s)/QC Leads/Supervisors to ensure planned training events&nbsp;were completed as scheduled and provide feedback as needed.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Conducts Observation, Side-by-Side, and Instructor Led Training inside of laboratory and CAR-T cGMP&nbsp;Manufacturing facility.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Conducts knowledge and skill check and independent performance qualifications for Quality Control&nbsp;Microbiology inside of laboratory and CAR-T cGMP Manufacturing facility.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure testing and training is completed in compliance with all applicable procedures, standards and&nbsp;GMP regulations.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support day to day Quality Control Microbiology activities as needed.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Perform peer review/ approval of laboratory data as needed.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Helps write or revise SOPs, Work Instructions, Job Aids, knowledge, and skills assessments.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work cross functionally with the training team to ensure the development/ qualification processes.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Supports investigations and evaluates improvement opportunities for effective compliant training&nbsp;performance leading to sustained right first-time execution.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide awareness trainings to the Quality Control Microbiology team.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Performs trainings within CAR-T manufacturing facility inside of cleanroom environments.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serve as subject matter expert for Learning Management Systems.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support the maintenance and reporting of quality training metrics.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Other duties will be assigned, as necessary.&nbsp;</li> </ul> Requirements <ul> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline&nbsp;is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A Minimum of 0-2 years relevant work experience, preferably within a biological and/or&nbsp;pharmaceutical industry is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience in a Quality Control setting is preferred.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience with biosafety cabinets is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Candidate must have experience working within an aseptic manufacturing facility,&nbsp;preferably within quality control, quality assurance, training/systems applications,&nbsp;quality systems, or learning management systems.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of&nbsp;cell-based products is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Knowledge of Good Tissue Practices is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience with training methodology, adult learning theory, and train-the-trainer&nbsp;programs.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Curriculum and module design experience.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Detailed knowledge of CAR-T QC test methods and related equipment is required</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Excellent written and oral communication skill are required</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Candidates must be able to accommodate occasional weekend and evening work&nbsp;as required by the manufacturing process.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The candidate must be highly organized and capable of working in a team&nbsp;environment with a positive attitude under some supervision.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Comfortable with speaking and interacting with inspectors.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">This position may require occasional travel to partner sites in NJ or PA as business&nbsp;demands.</li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">This position may require up to 5% domestic or international travel as business demands.&nbsp;</li> </ul> #Li-BZ1 #Li-Onsite<div class="content-pay-transparency"><div class="pay-input"><div class="description">The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: 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 voluntary benefits include flexible spending and health savings accounts, life and AD&amp;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 voluntary 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.</div><div class="title">Pay Range (Base Pay): </div><div class="pay-range">$81,273&mdash;$106,669 USD</div></div></div><div class="content-conclusion">Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. &nbsp; 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. &nbsp; Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. <div>&nbsp;</div> <div>For information related to our privacy policy, please review:&nbsp;<a href="https://legendbiotech.com/privacy-policy-2/" target="_blank">Legend Biotech Privacy Policy.</a></div></div>