Supervisor, Commercial Manufacturing, 2nd Shift

Orca Bio•Sacramento, CA

25d•$75,000 - $100,000•Onsite

About The Position

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. 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. This is a 2nd shift-based position , working on-site Monday through Friday, from 3pm to 11:30 pm.

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

Nice To Haves

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

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