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Legend Biotech

Associate Manufacturing Engineer at Legend Biotech

Raritan, New Jersey, United StatesFull-timeMSAT - RaritanPosted 20 days ago
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About the Role

<div class="content-intro"><p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Legend Biotech entered into a global collaboration agreement with Johnson &amp; Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.</span></p></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is seeking an <strong>Associate Manufacturing Engineer</strong> as part of the <strong>Manufacturing &amp; Supply</strong> team based in <strong>Raritan, NJ.</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Role Overview</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Associate Manufacturing Engineer, Tech Support will be part of the Technical Support team and be responsible to support the development and routine operation of a new CAR-T manufacturing process. They will be a subject matter expert for the manufacturing process and equipment primarily responsible for providing front line support to address and resolve manufacturing issues.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">This individual will partner closely with Quality, Compliance, and technical experts to drive accelerated, robust, and consistent resolution and escalation of process issues as applicable while ensuring batch quality and adherence to procedures and instructions. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support compliant manufacturing investigations and CAPAs, as subject matter experts.&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Be a point of contact with equipment suppliers for timely and continuous support. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Understand key process indicators of the manufacturing process and process execution and support opportunities for improvement and waste reduction.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">&nbsp;Perform regular manufacturing observations to collect process health data for the identification of process improvement and waste reduction opportunities.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Requirements</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">2-3 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide support and technical expertise to the Manufacturing team in support of ongoing manufacturing operations.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to accommodate changes in the schedule including working on shift as necessary to support operational needs.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support initiatives for process, operational, and quality improvements for manufacturing.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain processes at a state of audit readiness and support internal and external inspections as required.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to work with oversight and successfully execute and manage tasks for timely completion, Must respond to shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support the Manufacturing team to troubleshoot and resolve complex scientific/technical problems.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-RN1</span></p> <p><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&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.</p></div><div class="title">Pay Range (Base Pay): </div><div class="pay-range"><span>$78,251</span><span class="divider">&mdash;</span><span>$102,705 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 10pt; 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><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><strong>Work Authorization &amp; Employment Eligibility</strong></span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.</span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>EEO Statement</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">For information related to our privacy notice, please review:&nbsp;<a href="https://legendbiotech.com/privacy-notice/" target="_blank">Legend Biotech Privacy Notice</a>.</span></div></div>