Aseptic Manufacturing Technician I - Night Shift A [Contract to Hire]

Rotation Schedule: Week 1: Shift A: Sunday to Tuesday from 5:00pm to 5:30am Week 2 Shift A: Sunday to Wednesday from 5:00pm to 4:30am Overview: Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). TLead Aseptic Manufacturing Technician - Night Shift A Sun - Wed-5pm - 5:30am 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.

Qualifications

, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired. Aseptic Manufacturing Technicians are required to work their assigned schedule. e.

Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.

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.

Requirements

as documented. •Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). •Preps: oProvide operational support functions including: ▪Materials stocking and transfer.

▪Kit preparation. ▪Room readiness. ▪Equipment cleaning activities.

▪And inventory transactions using electronic inventory systems. •Hallway: oMaterial transfer. oTumor receipt.

oChain of Information/Chain of Custody transactions. oMaterial incubation. oFeeder cell retrieval from liquid nitrogen (LN2) tanks.

oAble to perform final product visual inspection. oFinal product cryopreservation in controlled rate freezers. •BSCR: oPerform biosafety cabinet (BSC) runner duties as assigned.

oBalance weight checks and operation. oOperation of liquid repeater pump. oOperation of tube sealers and welders.

oIncubator-use for cell culture. •EM: oPerform in-suite environmental monitoring during the day of process oPerform document Environmental Monitoring duties using sample management electronic system. •Miscellaneous: oAble to train, pass and maintain gowning qualification.

oPerform logbook review. oAttend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation. oAbility to work in a team environment and independently as required.

oMust adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. oMust comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. oAdherence to production schedule while maintaining internal production priorities.

oPerform other duties as assigned. Required Education, Skills, and Knowledge •Bachelor’s degree or equivalent experience.