About the role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Position Summary: You will focus on developing a process for antibody and antibody conjugate manufacturing, and facilitating tech transfer. You will jointly manage a GMP clean room in Menlo Park, CA, including equipment maintenance, inventory, logbook management and so on. You will perform process development and engineering runs in a GMP environment, contribute to process design, troubleshooting, scale-up/scale-out, assay development, and technology transfer to advance Orca’s clinical pipeline from first-in-human through commercialization. This role collaborates closely with members of the manufacturing, quality, facilities, and supply chain teams. \n Essential Duties & Key
Responsibilities: Bridge development and manufacturing activities by translating process learnings into robust, executable procedures, batch records, and tech transfer documentation. Perform development and engineering runs according to written procedures in a GMP environment. Perform investigations on process & product deviations for continuous process improvement. Help to manage a GMP clean room following Orca internal procedures. Share responsibility for equipment maintenance and calibration, inventory, environmental monitoring, and logbook management. Perform experiments and assays which increase process understanding and control. Help to perform stability and formulation studies. Collaborate with external vendors and internal teams to design and implement novel technologies for manufacturing, development, and tech transfer. Support continuous improvements of records and follow the operating procedure with strong attention to details. Maintain detailed records of experiments. Practice good data management and documentation habits. Organize and present data in a manner that is easily understood by other team members in lab notes, reports, and presentations. Closely collaborate with Orca teams across manufacturing, quality control, quality assurance, analytical development, and others. Required
