Axent Biosciences is seeking exceptional, highly motivated, and talented bioengineers/scientists to join our mission to revolutionize cell therapy manufacturing using Axent's 3D cell manufacturing platform. In this full-time Process Development role, the successful candidate will work with the R&D team in the iconic Bakar Labs to develop scalable upstream manufacturing processes for human pluripotent stem cells (hPSCs) and hPSC-derived cell types toward the goal of technology transfer to a cGMP manufacturing facility. The successful applicant will have a background in bioprocess engineering, biomaterials handling and characterization, automated liquid transfer systems, bioreactor operation, and hPSC culture and differentiation. Experience with 3D cell culture formats is preferred.
* Collaborate with R&D scientists and engineers to scale up, optimize, and tech transfer our cell manufacturing platform with a focus on upstream processes (biomaterial handling and characterization, hPSC expansion and differentiation, bioreactor process development and operation).
* Provide high-quality hPSC-derived cells to other scientists working on downstream process development, analytical assay development, and quality control.
* Collaborate with colleagues in downstream process development and analytical development to establish critical process parameters for critical quality attributes of the cell product(s).
* Evaluate platform technologies and instrumentation for internal use or potential outsourcing opportunities, and work with outside vendors for customized systems.
* Maintain accurate and thorough records of research and deliver formal scientific presentations and reports internally to interdisciplinary teams and supervisor(s) including progress reports, technical proposals, drafts of new protocols, standard operating procedures, batch records and other process and cGMP documentation.
* Support technology transfer and generation of data for regulatory fillings
* Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned.
* This position requires hands-on laboratory work with weekend and/or evening hours as necessary.
* B.S./M.S./Ph.D with 4+ years of relevant lab experience in chemical engineering, bioengineering, or a related discipline.
* Experience developing processes for the operation of bioreactors and closed bioprocessing systems
* Experience working with viscous biomaterials in large scales, bioprinting equipment, pumps, bead generation, particle size analysis.
* Experience working in a regulated environment; preferably in cell therapy.
* Experience with mammalian cell culture and culturing primary cells, ESCs or iPSCs, in-vitro differentiation of ESC/iPSCs. 3D culture and differentiation of hPSCs is a plus.
* Excellent teamwork, oral/written communication, time management, analytical, critical thinking, record-keeping, and organizational skills.
* High scientific integrity, committed to ethics and scientific rigor.