(US CITIZENS AND PERMANENT RESIDENTS ONLY)College degreeExperience with aseptic processing Experience with GMP Clean room experienceKnowledge of SOPs and good documentationSalary based on experience. There are 3 levels Under the supervision of the Associate Manager, the Manufacturing Associate processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by Company’s policies or client procedures being performed at each Cellular Production Facility.Responsibilities:Proficiently functions within an ISO Class 7 and 6 clean room environment, ensuring personal and product safetyPerforms cryopreservation of products using DMSO base solutions and controlled-rate freezersProficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devicesManipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpointsThawing and/or washing cryopreserved hematopoietic progenitor cell products either at the Clinical Site or in the facility as specified by standard operating proceduresPerforming facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating proceduresDesired Skills and ExperienceBachelor’s degree in a biologics or related field preferredA minimum of 4 years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing
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