Specialist, QA Process Excellence

<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"> </p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>Specialist, QA Process Excellence</strong> as part of the <strong>Quality </strong>team based in <strong>Raritan, NJ</strong>.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist in the development of process, operational, and quality improvements for manufacturing.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist in the review and development of process-related protocols and documentation.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide technical quality oversight for electronic batch records.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work independently perform assigned tasks.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">May support CSV activities as needed.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">May support equipment qualification activities as needed.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Drive continuous improvement. </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </li> </ul> <p class="col-xs-12 no-horiz-padding"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Requirements</strong></span></p> <ul> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">5+ years relevant work experience or equivalent. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 5 years must include quality assurance experience.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong knowledge of cell therapy processes strongly preferred.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience with Computer System Validation (CSV) is a plus.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience reviewing/auditing GMP documentation.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong interpersonal and written/oral communication skills.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to quickly process complex information and make critical decisions with limited information.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work independently and escalate to management when required.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Detail-oriented and able to follow procedures closely.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to identify and assess possible gaps and work collaboratively to address such issues.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Must be highly organized and capable of working in a team environment with a positive attitude.</span></li> <li class="col-xs-12 no-horiz-padding" style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong proficiency with using Microsoft Office applications. </span></li> </ul> <p class="col-xs-12 no-horiz-padding"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-RP1</span></p> <p class="col-xs-12 no-horiz-padding"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Onsite</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>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.</p> <p>Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.</p> <p>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&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.</p></div><div class="title">Pay Range (Base Pay): </div><div class="pay-range"><span>$75,972</span><span class="divider">—</span><span>$99,713 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.</strong></span></p> <p> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>EEO Statement</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.</span></p> <div> </div> <div><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For information related to our privacy policy, please review: <a href="https://legendbiotech.com/privacy-policy-2/" target="_blank">Legend Biotech Privacy Policy.</a></span></div></div>