Biomanufacturing Associate II

Responsibilities

• Perform routine cGMP manufacture of cell and gene therapy products including aseptic processing, cell isolation, culturing, and cryopreservation
• Lead manufacturing start-up activities such as authoring SOPs, batch records, and risk assessments
• Provide training to the team on equipment use, processes, and material flows
• Maintain cleanrooms in an organized and ready state
• Collaborate with cross-functional teams including Quality Assurance, Process Sciences, and Engineering to ensure successful technology transfer
• Resolve issues such as deviations, CAPAs, and Change Controls
• Generate and manage batch records, run reports, and batch data

Requirements

• Bachelor’s degree in biological sciences or related engineering
• 2-3+ years of experience in cGMP biotech manufacturing, preferably in cell and gene therapies
• Proficiency in aseptic technique and/or processing
• Experience with primary cell culture and equipment such as CliniMACS, bioreactors, or chromatography skids
• Strong communication and computer skills (Microsoft Excel, PowerPoint, Word)
• Ability to stand, walk, and lift up to 50 pounds while wearing PPE

Preferred Qualifications

• 2+ years of experience in project leadership
• Experience with CAR T, TCR, NK, AAV, or LV therapies

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.