About the role
<p><strong>Rotation Schedule:</strong></p> <p><strong>Week 1: Shift B: Thursday to Saturday from 0700 to 1930</strong></p> <p><strong>Week 2: Shift B: Wednesday to Saturday from 0700 to 1830</strong></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).&nbsp;</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>&nbsp;</strong></p> <p><strong>Essential Functions and&nbsp;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.</