iovancebiotherapeutics · Philadelphia, Pennsylvania · Philadelphia, Pennsylvania, United States
<p><strong>About</strong><strong> </strong><strong>Iovance Biotherapeutics, Inc.</strong><strong> </strong> </p> <p><a href="https://www.iovance.com/">Iovance Biotherapeutics</a><u>, Inc.</u> is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The <a href="https://www.iovance.com/our-science/til-platform/">Iovance TIL platform</a> spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit <a href="http://www.iovance.com/">www.iovance.com</a>. </p> <p>Amtagvi® and its accompanying design marks, Proleukin<sup>®</sup>, Iovance<sup>®</sup>, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. </p> <p>Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on <a href="http://www.iovance.com/">www.iovance.com</a>. </p> <p><strong>Overview</strong></p> <p>Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). </p> <p>The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.</p> <p>As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use.</p> <p>This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.</p> <p>As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.</p> <p><strong><em>Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1<sup>st</sup> shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.</em></strong><strong> </strong></p> <p> </p> <p style="padding-left: 40px;"></p> <p style="padding-left: 40px;"><strong>Rotation Schedule:</strong></p> <p style="padding-left: 40px;"><strong>Week 1: Shift A: Sunday to Wednesday from 1800 to 0530</strong></p> <p style="padding-left: 40px;"><strong>Week 2 Shift A: Sunday to Tuesday from 1800 to 0630</strong></p> <p> </p> <p><strong>Essential Functions and Responsibilities:</strong></p> <ul> <li>Develop a comprehensive understanding of and be able to proficiently execute Iovance’s GMP cell therapy manufacturing process(es).</li> <li>Complete training sessions and ensure training documentation is maintained.</li> <li>Understand and comply with quality standards and requirements as documented.</li> <li>Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).</li> <li><strong>Preps</strong>: <ul> <li>Provide operational support functions including: <ul> <li>Materials stocking and transfer.</li> <li>Kit preparation.</li> <li>Room readiness.</li> <li>Equipment cleaning activities.</li> <li>And inventory transactions using electronic inventory systems.</li> </ul> </li> <li><strong>Hallway:</strong><strong> </strong> <ul> <li>Material transfer.</li> <li>Tumor receipt.</li> <li>Chain of Information/Chain of Custody transactions.</li> <li>Material incubation.</li> <li>Feeder cell retrieval from liquid nitrogen (LN2) tanks.</li> <li>Able to perform final product visual inspection.</li> <li>Final product cryopreservation in controlled rate freezers.</li> </ul> </li> <li><strong>BSCR:</strong> <ul> <li>Perform biosafety cabinet (BSC) runner duties as assigned.</li&