Supervisor, Cell Therapy Manufacturing
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About The Position
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. We are looking for a dynamic individual to join and contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility, including CAR-Ts, iPSCs, Adeno-Associated Virus (AAV), and Lentivirus (LV). The ideal candidate should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, with a willingness and aptitude for adopting new technology, an ability to build relationships, and work effectively in a cross-functional team, while committing to the highest safety and quality standards. In this role, you will lead right-first-time cGMP manufacturing of cell and gene therapy products, which includes aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish, and final product visual inspection. You will also lead manufacturing/operations start-up activities, including authoring SOPs, batch records, reports, risk assessments, and managing material ordering. Your responsibilities will include providing constructive input on team selections for equipment, process, and material flows, creating and maintaining training materials, and ensuring effective collaboration with cross-functional teams to ensure right-first-time technology transfer. You will work closely with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, and Change Controls, while ensuring the highest safety and quality standards in service of our colleagues and patients. Additionally, you will generate and manage batch records, run reports, and batch data for manufacturing and scale-up activities, while proactively identifying opportunities for improvements in process, safety, quality, and cost. You will play an integral role in providing hands-on technical, organizational, and leadership expertise to the start-up activity for ElevateBio's state-of-the-art cGMP cell and gene therapy manufacturing facility. This includes ensuring the safety of assigned areas and work practices in accordance with the EHS program, reviewing Job Hazard Analyses (JHA) regularly, and providing daily management oversight for the team to ensure processes are executed with cGMP. You will also be responsible for recruiting and developing staff, maintaining and reporting department metrics to drive operational improvement, and balancing daily production demands to ensure right-first-time execution.
