Operations Associate

Legend Biotech·
Raritan, New Jersey, United States
2w ago
EntryManufacturingNeurology
From $57K/yr(estimated)

Description

<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><div class="col-xs-12 no-horiz-padding"><hr><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking <strong>Operations Associate</strong> as part of the <strong>Technical Operations </strong>team based in <strong>Raritan, NJ. </strong></span> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.</span></p> <p class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Shift Schedule: Wed-Sat 1st Shift</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><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;">Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform tasks on time in a manner consistent with quality systems and cGMP requirements.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Work in a team based, cross-functional environment to complete production tasks required by shift schedule.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Aid in the development of manufacturing processes including appropriate documentation.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Handle human derived materials in containment areas.<br></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 schedule adjustments to meet production.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Accurately complete documentation in SOP’s, logbooks and other GMP documents.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrate training progression through assigned curriculum.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Wear the appropriate PPE when working in manufacturing and other hazardous working environments.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure materials are available for production.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Color Perception both eyes 5 slides out of 8</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 ongoing production schedule by:</span> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Report to work on-time and according to the shift schedule.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform other duties as assigned.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Attend departmental and other scheduled meetings.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Practice good interpersonal and communication skills.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrate positive team-oriented approach in the daily execution of procedures.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Promote and work within a team environment<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Learn new skills, procedures and processes as assigned by management and continue to develop professionally.<br></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 investigation efforts as required.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for audit preparation and participation.</span></li> </ul> </li> </ul> </div> <div class="col-xs-12 no-horiz-padding"> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Requirements</span></h3> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">HS Diploma required with 3 – 5 Years Biotech/Pharmaceutical experience or equivalent industry experience // OR // Associates Degree required in Life Sciences or Manufacturing with 2 - 3 years of related experience // OR //Bachelors Degree required in Life Sciences with 0 - 2 years Biotech/Pharmaceutical experience or equivalent industry experience<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Interpret a variety of instructions furnished in written, oral, diagram or schedule form.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Follow instructions<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Knowledge of Process Excellence Tools<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Is frequently required to communicate with coworkers.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.<br></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 lift 25 lbs.<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Needs to perform gowning procedures to work in manufacturing core.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-DD1</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Onsite</span></p> <hr></div> <p> </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>$57,445</span><span class="divider">—</span><span>$75,396 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>
Legend Biotech

Legend Biotech

BIOTECHNOLOGY

Cell Therapy

LocationNJ - Piscataway
Open Jobs106
Gene TherapyCell Therapy
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