Cell Therapy Production Associate, Oncology, 3rd Shift

Overview

More than one million people in the United States today are fighting blood cancer. Orca Bio is a late-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 investigational 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.

This is a 3rd shift-based position, working on-site Monday through Thursday, from 9pm to 7:30am. The Cell Therapy Production Associate, Oncology 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.

• Production Associates:
  Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

• 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
• Required to participate in an on-call rotation as needed for weekend and/or holiday shifts

• 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

• Highly detail oriented with special attention to quality and documentation
• Strong work ethic, curiosity to learn and contribute in a fast-paced, collaborative environment
• Excellent interpersonal skills and ability to communicate effectively
• Ability to work both independently and in a collaborative manner
• Highly tolerant…