Aseptic Manufacturing Technician I - Day Shift B [Contract to Hire]

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Rotation Schedule: Week 1: Shift B: Thursday to Saturday from 0700 to 1930 Week 2 Shift B: Wednesday to Saturday from 0700 to 1830 Overview Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). 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. 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. 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. 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. 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 st 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. Essential Functions and Responsibilities: Develop a comprehensive understanding of and be able to proficiently execute Iovance’s GMP cell therapy manufacturing process(es). Complete training sessions and ensure training documentation is maintained. Understand and comply with quality standards and requirements as documented. Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Preps : Provide operational support functions including: Materials stocking and transfer. Kit preparation. Room readiness. Equipment cleaning activities. And inventory transactions using electronic inventory systems. Hallway: Material transfer. Tumor receipt. Chain of Information/Chain of Custody transactions. Material incubation. Feeder cell retrieval from liquid nitrogen (LN2) tanks. Able to perform final product visual inspection. Final product cryopreservation in controlled rate freezers. BSCR: Perform biosafety cabinet (BSC) runner duties as assigned. Balance weight checks and operation. Operation of liquid repeater pump. Operation of tube sealers and welders. Incubator-use for cell culture. EM: Perform in-suite environmental monitoring during the day of process Perform document Environmental Monitoring duties using sample management electronic system. Miscellaneous: Able to train, pass and maintain gowning qualification. Perform logbook review. Attend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation. Ability to work in a team environment and independently as required. ... (truncated, view full listing at source)