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Supervisor, Commercial Manufacturing - Night Shift
full timeSacramento, CA
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AT A GLANCE
ManufacturingSupervisor level2+ years experienceFull TimeRegular, Full-Time Employee
Required
- 2+ years experience
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
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 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 Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
Night Shift:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday
Responsibilities
- Supervise and lead a team of associates, cell therapy production, oncology during assigned shift operations.
- Coordinate daily manufacturing activities to meet schedule, and quality and compliance goals.
- Execute and enforce cGMP-compliant SOPs, batch records, and safety procedures
- Provide on-the-floor training, mentorship, and performance feedback to production staff
- Monitor and troubleshoot production activities and equipment, escalating as needed
- Partner with QA and QC to support in-process checks, deviation investigations, and batch record reviews
- Maintain real-time, accurate documentation of manufacturing processes and equipment use
- Support continuous improvement initiatives to increase reliability and efficiency.
- Participate in CAPA and deviation investigations related to manufacturing activities
Requirements
- B.S. degree required in biology or related field
- 2+ years of supervisory or team experience is required
- Strong understanding of aseptic manufacturing practices and clean room operations
- M.S. degree in biology or related field
- Prior experience in cell therapy or other advanced biologics
- Familiarity with deviation investigations, CAPAs and change control processes
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