Qualifications
Proven experience in managing manufacturing operations, preferably within the biotechnology or pharmaceutical sector. Strong knowledge of Good Manufacturing Practices (GMP) and quality control processes. Expertise in implementing lean manufacturing principles and continuous improvement methodologies. Exceptional leadership and communication skills, with a proven ability to collaborate across departments. Advanced degree in a relevant field (e.g., Biotechnology, Engineering, Business Administration) is preferred.
About the job
Over one million individuals in the United States are currently battling blood cancer. While the traditional
allogeneic stem cell transplant has provided hope for many, it can also carry significant risks, including fatal outcomes and severe complications such as graft versus host disease. At Orca Bio, a cutting-edge biotechnology firm, we are revolutionizing the transplant process by creating next-generation cell therapies aimed at significantly enhancing survival rates while minimizing risks. Our goal is to not only replace patients' blood and immune systems with healthy alternatives but also to restore their quality of life.
We have established a state-of-the-art 100,000-square-foot manufacturing facility in Sacramento, CA, to guarantee the consistent and reliable delivery of our high-precision cell therapy products. This facility is crucial for advancing our clinical pipeline and ensuring the future commercial availability of our life-saving therapies.
The Director, Commercial Manufacturing will lead our cell therapy manufacturing operations and production support functions to ensure the reliable, compliant, and timely delivery of patient-specific therapies. This role is essential in driving consistent batch execution, operational discipline, and cross-functional collaboration to meet on-time patient delivery, all while upholding the highest quality and safety standards.
The Director will develop and maintain robust production systems, implement lean manufacturing principles, and spearhead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.