Cell Therapy Production Associate, Oncology (1st - 3rd Shifts)
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 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.
MANY POSITIONS AVAILABLE!
- 1st shift: 7am-3:30pm, M-F
- 2nd shift: 3pm-11:3pm, M-F
- 3rd shift: 9pm-7:30am, M-Th
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 manufacturing shift supervisor, 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.
Key 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
- Required to participate in an on-call rotation as needed for weekend and/or holiday shifts
Minimum Qualifications:
- 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
Preferred Qualifications:
- Experience working in GMP-compliant environments
- Involvement in investigations, deviations, and change control processes
- B.S. degree in Biological or related sciences
Physical Demands:
- Must be able to remain in a stationary position ~50% of the time while in a biosafety cabinet/cleanroom environment, which includes wearing a PPE gown
- Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
- Occasional need to ascend/descend stairs within workspace; job requires standing/walking
Personal Qualities:
- 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 and respectful of all team members
- A sense of humor is always appreciated