Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
About the role
The Engineer, Packaging and Labeling is responsible for the lifecycle management of Final Drug Product, packaging systems, labeling components, cold chain packaging equipment, and cryopreservation equipment supporting the manufacture and distribution of commercial cell therapy products. This role ensures packaging and labeling systems comply with GMP, regulatory, and patient-specific requirements while maintaining product integrity throughout manufacturing, cryogenic storage, transportation, and delivery.
What they're looking for
- Bachelor’s degree in Life Sciences, Engineering, or related field (required)
- Advanced degree (MS, MBA, or PhD) preferred
- 2+ years of experience in biopharmaceutical manufacturing, with a strong preference for cell or gene therapy, packaging operations and / or cold chain management
- Knowledge of cGMP regulations and regulatory expectations
- Background in lean manufacturing and operational excellence methodologies
More about this 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 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.
The Engineer, Packaging and Labeling is responsible for the lifecycle management of Final Drug Product, packaging systems, labeling components, cold chain packaging equipment, and cryopreservation...
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