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Cell Therapy Production Associate, Oncology - Night Shift (Multiple Positions)
full timeSacramento, CA
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AT A GLANCE
Manufacturing2+ years experienceFull TimeRegular, Full-Time EmployeeHigh school diploma required
Required
- 2+ years experience
- High school diploma
- Associate degree
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 Cell Therapy Production Associate, Oncology - Night Shift plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.
Night Shift Hours Worked:
• 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
- Operate and closely monitor advanced manufacturing equipment to support the production of cutting-edge cell therapy products
- Follow and execute standard operating procedures (SOPs) and batch records to perform production activities
- Identify and resolve equipment or process issues, escalating to management as necessary
- Complete all assigned training to maintain required technical proficiency and adhere to cGMP standards
- Operate, monitor, clean, and prepare advanced automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments. All required PPE and GMP-compliant gowning are provided by the company
- Contribute to continuous improvement efforts, including manufacturing efficiency, compliance practices, and support for investigations, deviations, and change control processes
Requirements
- Associate degree and at least 1 year of experience in biomanufacturing, OR
- High School Diploma/GED with a minimum of 2 years of biomanufacturing experience
- Experience working in GMP-compliant environments
- Involvement in investigations, deviations, and change control processes
- B.S. degree in Biological or related sciences
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