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. We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory
requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives. \n Essential Duties & Key
Responsibilities: Oversee execution of routine manufacturing and occasional scientific protocols Develop and refine procedures for cell separation technologies, sterile connections, and aseptic techniques Serve as subject matter expert for cell therapy processes and new technology Provide verification for results and ensure detailed records are maintained Prepare, maintain, trouble-shoot, and operate instruments Plan the shift - including break management, shift pass downs, and process appropriate decisions Supervise in-room operations and delegate individual tasks based on operator capacity Complete deviations Escalate issues appropriately Review and support continuous improvements of business processes, records, and SOPs Training and coaching employees Other duties as assigned Minimum
