Biomanufacturing Associate II

Responsibilities

• Perform routine cGMP manufacture of cell and gene therapy products including aseptic processing, cell isolation, culturing, and cryopreservation
• Lead upstream and downstream processing, aseptic fill finish, and final product visual inspection
• Author SOPs, batch records, reports, risk assessments, and manage material ordering
• Provide training to the team on equipment set-up, processes, and material flows
• Maintain clean rooms in an organized and ready state
• Collaborate with cross-functional teams including Process Sciences, Quality Control, and Quality Assurance to resolve deviations, CAPAs, and Change Controls
• Generate and manage batch records and run reports for manufacturing and scale-up activities

Requirements

• Bachelor’s degree in biological sciences or related engineering
• Proficiency in aseptic technique and/or processing
• Experience with cGMP manufacture or process development for CAR T, TCR, NK, cellular therapies, AAV, LV, or RV
• Advanced understanding of primary cell culture
• Experience with equipment such as CliniMACS Plus, CliniMACS Prodigy, LOVO, bioreactors, chromatography skids, or TFF
• Excellent computer skills including Microsoft Excel, PowerPoint, and Word
• Ability to work rotating 12-hour day shifts and available for overtime including weekends and holidays

About the Company

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization through integrated technologies and manufacturing expertise.