Associate Manager, QC at Legend Biotech

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 an Associate Manager, QC as part of the Quality team based in Raritan, NJ. Role Overview The QC Associate Manager is an exempt level position with responsibilities for managing the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data and methods, supporting laboratory investigations and ownership of various QC department projects. Key Responsibilities <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensuring adequate training (skills-based, cGMP and safety) of associates within the department</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Oversight of raw material, in-process, environmental/utility, product release, and stability testing, investigation of laboratory non-conformances (events, deviations, and invalid assays), and maintenance, calibration and qualification of laboratory instruments and equipment.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support test method verification, qualification, validation and/or transfer activities in the QC laboratories in conjunction with QC Management and QA Validation/Equipment groups.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations. Make quick, informed decisions with minimal to no supervision during 2nd shift hours.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Other duties will be assigned, as necessary.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Authority to make decisions related to day-to-day processing of batches in the QC laboratory. Decisions must be made in conjunction with the Quality Assurance team if an issue is not addressed by any Legend Biotech Standard Operating Procedure. Decisions related to project execution, including timelines, milestones and resource allocation within budget can be made in collaboration with QC Leadership. Higher-level approvals are required for those related to significant budget allocations, strategic shifts, or major collaborations that have substantial financial or long-term implications.&nbsp;</li> </ul> Requirements <ul> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A minimum of 8 to 10 years of relevant work experience is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A minimum of 2 to 4 years of direct people leadership experience is REQUIRED.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Required shift hours will be Monday-Friday, 5PM-1:30AM</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience in clinical quality, method development, cell banking, cell therapy, or Research &amp; Development is preferred.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">People management or leadership experience is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience working with Quality systems is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience with quality support in clinical manufacturing or NPI is preferred.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Extensive knowledge of chemical, biochemical and microbiological concepts is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Knowledge of cGMP regulations and FDA/EU guidance is required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal to no supervision.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Comfortable with speaking to and interacting with inspectors and supporting additional regulatory audit activities as needed.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Good written and verbal communication skills are required.</li> <li class="col-xs-12 no-horiz-padding" style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.&nbsp;</li> </ul> #Li-RP1 #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">$93,463&mdash;$122,670 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>

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Associate Manager, QC

Description

Legend Biotech