Manager, Quality Control

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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.

Position Summary:

The Manager, Quality Control is responsible for providing oversight for the GMP testing of cell therapy products and critical intermediates. Additionally, this role will support regulatory and internal inspections and oversee key aspects of quality control workflows, including leading investigations of out‑of‑specification results and addressing environmental monitoring excursions. This position will work cross-functionally to ensure that products are sampled and tested under applicable regulations and guidelines of current Good Manufacturing Practices (cGMPs). There are regular interactions with internal manufacturing and with service providers. The successful candidate shall be an experienced manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.

Originally posted by MD Stem Cells. View original posting

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